diff --git a/IWRS/Patients/IncomingSourceReports/2026-06-02 42847922MDD3003 Subject Summary Report.xlsx b/IWRS/Patients/IncomingSourceReports/2026-06-02 42847922MDD3003 Subject Summary Report.xlsx new file mode 100644 index 0000000..0a498f6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReports/2026-06-02 42847922MDD3003 Subject Summary Report.xlsx differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..e4c0590 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 6545, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-08-05", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 04-Aug-2025 \n\nDate of Screening in IRT: 05-Aug-2025 \nTransaction Date/Time (site local): 05-Aug-2025 09:24:09\nTransaction Date/Time (system local): 05-Aug-2025 07:24:09\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..d9d881b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d4c9e47 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 6760, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been screened at site S10-CZ10004", + "event": "Screen", + "actual_date": "2025-08-08", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 08-Aug-2025 \n\nDate of Screening in IRT: 08-Aug-2025 \nTransaction Date/Time (site local): 08-Aug-2025 09:39:48\nTransaction Date/Time (system local): 08-Aug-2025 07:39:48\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..d7abb34 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-08_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_screened_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..72ddd50 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7427, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-08-26", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1019782\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-Aug-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1020699\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-Aug-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Aug-2025 13:17:53\n\nTransaction Date/Time (system local): 26-Aug-2025 11:17:53 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..523bdaf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.json new file mode 100644 index 0000000..611446e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.json @@ -0,0 +1,10 @@ +{ + "pk": 8785, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-08-26", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1003030\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 23-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1186247\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 23-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 23-Sep-2025 11:17:14\n\nTransaction Date/Time (system local): 23-Sep-2025 09:17:14 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.pdf new file mode 100644 index 0000000..45347d1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8785.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..d2ea756 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7426, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 randomized into Part 1 at site S10-CZ10008", + "event": "Rand", + "actual_date": "2025-08-26", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1019782Seltorexant 20mg or placeboT38028505-Apr-20261020699Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Aug-2025 13:03:37\nTransaction Date/Time (system local): 26-Aug-2025 11:03:37\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..6b38fbd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..5109d91 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7414, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-08-26", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080004 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 25-Aug-2025 \n\nDate of Screening in IRT: 26-Aug-2025 \nTransaction Date/Time (site local): 26-Aug-2025 09:33:38\nTransaction Date/Time (system local): 26-Aug-2025 07:33:38\n\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..088ed8f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-08-26_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.json new file mode 100644 index 0000000..b479fab --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 7772, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100120002 has been screened at site S10-CZ10012", + "event": "Screen", + "actual_date": "2025-09-03", + "subject": "CZ100120002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120002 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Sep-2025 \n\nDate of Screening in IRT: 03-Sep-2025 \nTransaction Date/Time (site local): 03-Sep-2025 13:44:09\nTransaction Date/Time (system local): 03-Sep-2025 11:44:09\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..01d8ce9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-03_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screened_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..76cc0ef --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 7946, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 randomized into Part 1 at site S10-CZ10004", + "event": "Rand", + "actual_date": "2025-09-05", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1109895Seltorexant 20mg or placeboT38028505-Apr-20261125335Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Sep-2025 10:23:26\nTransaction Date/Time (system local): 05-Sep-2025 08:23:26\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..1574ada Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-05_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_1_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..25a056b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8056, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-09-09", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1043808\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1056387\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 09-Sep-2025 12:10:27\n\nTransaction Date/Time (system local): 09-Sep-2025 10:10:27 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..ea4566e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.json new file mode 100644 index 0000000..c5144ad --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.json @@ -0,0 +1,10 @@ +{ + "pk": 9416, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-09-09", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1206881\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 07-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1299156\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 07-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 07-Oct-2025 12:04:04\n\nTransaction Date/Time (system local): 07-Oct-2025 10:04:04 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.pdf new file mode 100644 index 0000000..2e2ff20 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9416.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..18bd72a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8055, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008", + "event": "DB_P1_V6", + "actual_date": "2025-09-09", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1043808Seltorexant 20mg or placeboT38028505-Apr-20261056387Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 09-Sep-2025 12:09:34 \nTransaction Date/Time (system local): 09-Sep-2025 10:09:34 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..b726891 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..e7627ff --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8124, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-09-10", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 09-Sep-2025 \n\nDate of Screening in IRT: 10-Sep-2025 \nTransaction Date/Time (site local): 10-Sep-2025 10:44:50\nTransaction Date/Time (system local): 10-Sep-2025 08:44:50\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..c14a72a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..469c11c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8351, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-09-16", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080004 has\nbeen performed for the following medication IDs:\n\nMedication No: 1076269\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 16-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1094935\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 16-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 16-Sep-2025 12:54:42\n\nTransaction Date/Time (system local): 16-Sep-2025 10:54:42 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..e7b7b2e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..b232246 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8350, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 randomized into Part 1 at site S10-CZ10008", + "event": "Rand", + "actual_date": "2025-09-16", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080004 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1076269Seltorexant 20mg or placeboT38028505-Apr-20261094935Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 16-Sep-2025 12:53:29\nTransaction Date/Time (system local): 16-Sep-2025 10:53:29\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..c194eee Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080004_randomized_into_Part_1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..b7b12ba --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8335, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080006 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-09-16", + "subject": "CZ100080006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080006 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080006 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 15-Sep-2025 \n\nDate of Screening in IRT: 16-Sep-2025 \nTransaction Date/Time (site local): 16-Sep-2025 09:14:53\nTransaction Date/Time (system local): 16-Sep-2025 07:14:53\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..5dff02b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-16_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json new file mode 100644 index 0000000..2a69eaf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 8636, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10004", + "event": "DB_P1_V6", + "actual_date": "2025-09-19", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1077721Seltorexant 20mg or placeboT38028505-Apr-20261173637Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 19-Sep-2025 11:44:36 \nTransaction Date/Time (system local): 19-Sep-2025 09:44:36 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e750e6b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ed8eac0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 8681, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-09-22", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1077721\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 19-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1173637\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 19-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1109895\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1125335\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Sep-2025 09:50:51\n\nTransaction Date/Time (system local): 22-Sep-2025 07:50:51 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..2530114 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.json new file mode 100644 index 0000000..214f4f6 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.json @@ -0,0 +1,10 @@ +{ + "pk": 9348, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-09-22", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1033211\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 03-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1183601\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 03-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 06-Oct-2025 08:58:27\n\nTransaction Date/Time (system local): 06-Oct-2025 06:58:27 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.pdf new file mode 100644 index 0000000..abe0277 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk9348.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..9c7f00c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 8682, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-09-22", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1109895\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1125335\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Sep-2025 09:51:59 \nTransaction Date/Time (system local): 22-Sep-2025 07:51:59 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..2de01e2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.json new file mode 100644 index 0000000..388c094 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.json @@ -0,0 +1,10 @@ +{ + "pk": 9349, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-09-22", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1077721\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1173637\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 06-Oct-2025 08:59:42 \nTransaction Date/Time (system local): 06-Oct-2025 06:59:42 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.pdf new file mode 100644 index 0000000..6b5301c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-22_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004_pk9349.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..84e455d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8783, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 Rolled Over from Part 1 into Part 2 at site S10-CZ10008", + "event": "DB_P1_V7", + "actual_date": "2025-09-23", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 23-Sep-2025 11:15:47\nTransaction Date/Time (system local): 23-Sep-2025 09:15:47\n\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..1a2a816 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json new file mode 100644 index 0000000..29f097f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8784, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10008", + "event": "DB_P1_V7", + "actual_date": "2025-09-23", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1003030Seltorexant 20mg or placeboT38028505-Apr-20261186247Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 23-Sep-2025 11:15:45 \nTransaction Date/Time (system local): 23-Sep-2025 09:15:45 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..e70982f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-23_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.json new file mode 100644 index 0000000..8d42564 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 9146, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100120002 has been screen failed at site S10-CZ10012", + "event": "uv_screen_fail", + "actual_date": "2025-09-29", + "subject": "CZ100120002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120002 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 29-Sep-2025\nTransaction Date/Time (site local): 01-Oct-2025 12:24:16\nTransaction Date/Time (system local): 01-Oct-2025 10:24:16\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..89b4d3e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100120002_has_been_screen_failed_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..bd8b5a0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9092, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-09-30", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080004 has\nbeen performed for the following medication IDs:\n\nMedication No: 1113623\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 30-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1192373\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 30-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 30-Sep-2025 11:23:38\n\nTransaction Date/Time (system local): 30-Sep-2025 09:23:38 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..bdfcac5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..d1f2438 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9091, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008", + "event": "DB_P1_V6", + "actual_date": "2025-09-30", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080004 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1113623Seltorexant 20mg or placeboT38028505-Apr-20261192373Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 30-Sep-2025 11:22:42 \nTransaction Date/Time (system local): 30-Sep-2025 09:22:42 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..0af6b97 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-09-30_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.json new file mode 100644 index 0000000..754448a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 9144, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100120003 has been screened at site S10-CZ10012", + "event": "Screen", + "actual_date": "2025-10-01", + "subject": "CZ100120003", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120003 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120003 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Oct-2025 \n\nDate of Screening in IRT: 01-Oct-2025 \nTransaction Date/Time (site local): 01-Oct-2025 12:11:44\nTransaction Date/Time (system local): 01-Oct-2025 10:11:44\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..790868b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-01_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screened_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ddb85d2 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 9285, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 Rolled Over from Part 1 into Part 2 at site S10-CZ10004", + "event": "DB_P1_V7", + "actual_date": "2025-10-03", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 03-Oct-2025 13:17:58\nTransaction Date/Time (system local): 03-Oct-2025 11:17:58\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..7453c69 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json new file mode 100644 index 0000000..7d3a2ec --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 9286, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10004", + "event": "DB_P1_V7", + "actual_date": "2025-10-03", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1033211Seltorexant 20mg or placeboT38028505-Apr-20261183601Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 03-Oct-2025 13:17:57 \nTransaction Date/Time (system local): 03-Oct-2025 11:17:57 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..ac0a431 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..99f20ee --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 9272, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110004 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2025-10-03", + "subject": "CZ100110004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110004 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110004 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Oct-2025 \n\nDate of Screening in IRT: 03-Oct-2025 \nTransaction Date/Time (site local): 03-Oct-2025 09:57:26\nTransaction Date/Time (system local): 03-Oct-2025 07:57:26\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..34f5c1c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-03_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..feb1f82 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9415, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10008", + "event": "OL_Ind_V1_1", + "actual_date": "2025-10-07", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1206881Seltorexant 20mgT37484802-May-20261299156Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 07-Oct-2025 12:02:51 \nTransaction Date/Time (system local): 07-Oct-2025 10:02:51 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..67fea6f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..fdd7cac --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9513, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-08", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1123910\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1148249\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 08-Oct-2025 13:01:35\n\nTransaction Date/Time (system local): 08-Oct-2025 11:01:35 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..74751c8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.json new file mode 100644 index 0000000..9ce2459 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.json @@ -0,0 +1,10 @@ +{ + "pk": 11269, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-08", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1039446\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 12-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1051859\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 12-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 12-Nov-2025 11:19:30\n\nTransaction Date/Time (system local): 12-Nov-2025 10:19:30 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.pdf new file mode 100644 index 0000000..6609511 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11269.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..3f44782 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9511, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 randomized into Part 1 at site S10-CZ10008", + "event": "Rand", + "actual_date": "2025-10-08", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1123910Seltorexant 20mg or placeboT38028505-Apr-20261148249Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 08-Oct-2025 11:41:30\nTransaction Date/Time (system local): 08-Oct-2025 09:41:30\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..e739cf2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080005_randomized_into_Part_1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json new file mode 100644 index 0000000..aa794b2 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9821, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 has been discontinued from IRT managed treatment at site S10-CZ10008", + "event": "uv_discontinue", + "actual_date": "2025-10-14", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100080004 has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 14-Oct-2025 \nTransaction Date/Time (site local): 15-Oct-2025 14:56:51\nTransaction Date/Time (system local): 15-Oct-2025 12:56:51\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..8c895ff Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-14_Janssen_42847922MDD3003_Subject_CZ100080004_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ed01dbb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 9967, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10004", + "event": "OL_Ind_V1_1", + "actual_date": "2025-10-17", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1284494Seltorexant 20mgT37484802-May-20261297594Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Oct-2025 12:00:57 \nTransaction Date/Time (system local): 17-Oct-2025 10:00:57 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..3231a06 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.json new file mode 100644 index 0000000..f0611d6 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 10680, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100110004 has been screen failed at site S10-CZ10011", + "event": "uv_screen_fail", + "actual_date": "2025-10-17", + "subject": "CZ100110004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110004 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 17-Oct-2025\nTransaction Date/Time (site local): 31-Oct-2025 08:27:45\nTransaction Date/Time (system local): 31-Oct-2025 07:27:45\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d83eb22 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100110004_has_been_screen_failed_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..fff8913 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10013, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-10-20", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1284494\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1297594\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Oct-2025 08:35:08\n\nTransaction Date/Time (system local): 20-Oct-2025 06:35:08 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e748f41 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..4ef84aa --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10012, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-10-20", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1033211\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1183601\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Oct-2025 08:33:59 \nTransaction Date/Time (system local): 20-Oct-2025 06:33:59 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..4c4b1c1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json new file mode 100644 index 0000000..f2b9ec1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10103, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10008", + "event": "OL_Ind_V1_4", + "actual_date": "2025-10-21", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1263293Seltorexant 20mgT37484802-May-20261284662Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 21-Oct-2025 11:10:07 \nTransaction Date/Time (system local): 21-Oct-2025 09:10:07 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..5140624 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-21_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..f12ddde --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10195, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-22", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1017229\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1018200\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Oct-2025 10:53:58\n\nTransaction Date/Time (system local): 22-Oct-2025 08:53:58 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..2fbfdbf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.json new file mode 100644 index 0000000..a7ec86c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.json @@ -0,0 +1,10 @@ +{ + "pk": 11621, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-22", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1223095\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1241228\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 18-Nov-2025 11:20:59\n\nTransaction Date/Time (system local): 18-Nov-2025 10:20:59 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.pdf new file mode 100644 index 0000000..a7b4e8f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk11621.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..0e89dd6 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10194, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008", + "event": "DB_P1_V6", + "actual_date": "2025-10-22", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1017229Seltorexant 20mg or placeboT38028505-Apr-20261018200Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Oct-2025 10:52:42 \nTransaction Date/Time (system local): 22-Oct-2025 08:52:42 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..c9bd918 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2065c82 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10363, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-24", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1263293\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 21-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1284662\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 21-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Oct-2025 14:49:04\n\nTransaction Date/Time (system local): 24-Oct-2025 12:49:04 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..723da9c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-24_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..a24ba40 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10530, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080006 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-29", + "subject": "CZ100080006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1032775\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1038889\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 29-Oct-2025 10:22:00\n\nTransaction Date/Time (system local): 29-Oct-2025 09:22:00 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..80286f5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.json new file mode 100644 index 0000000..5d52e93 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.json @@ -0,0 +1,10 @@ +{ + "pk": 12065, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080006 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-29", + "subject": "CZ100080006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1097147\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1115018\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 25-Nov-2025 09:41:01\n\nTransaction Date/Time (system local): 25-Nov-2025 08:41:01 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.pdf new file mode 100644 index 0000000..54e633a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk12065.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2a23b52 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10529, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100080006 randomized into Part 1 at site S10-CZ10008", + "event": "Rand", + "actual_date": "2025-10-29", + "subject": "CZ100080006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080006 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1032775Seltorexant 20mg or placeboT38028505-Apr-20261038889Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 29-Oct-2025 10:20:55\nTransaction Date/Time (system local): 29-Oct-2025 09:20:55\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..4998245 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-29_Janssen_42847922MDD3003_Subject_CZ100080006_randomized_into_Part_1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json new file mode 100644 index 0000000..cc1c9d8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10688, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10004", + "event": "OL_Ind_V1_4", + "actual_date": "2025-10-31", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1222097Seltorexant 20mgT37484802-May-20261267690Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 31-Oct-2025 10:21:22 \nTransaction Date/Time (system local): 31-Oct-2025 09:21:22 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..df10fa9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..7cbb0ab --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10740, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-11-03", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1222097\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 31-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1267690\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 31-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Nov-2025 08:56:53\n\nTransaction Date/Time (system local): 03-Nov-2025 07:56:53 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..ea3741e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..e924575 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10739, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-11-03", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1284494\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1297594\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Nov-2025 08:56:15 \nTransaction Date/Time (system local): 03-Nov-2025 07:56:15 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..db7a51b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..2388b27 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 10748, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110005 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2025-11-03", + "subject": "CZ100110005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110005 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110005 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Nov-2025 \n\nDate of Screening in IRT: 03-Nov-2025 \nTransaction Date/Time (site local): 03-Nov-2025 09:39:17\nTransaction Date/Time (system local): 03-Nov-2025 08:39:17\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..e7c14d9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..c3ff974 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10834, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-11-04", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1247490\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 04-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1268140\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 04-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 04-Nov-2025 12:15:05\n\nTransaction Date/Time (system local): 04-Nov-2025 11:15:05 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..d129321 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2bb673d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10833, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10008", + "event": "OL_Ind_V1_5", + "actual_date": "2025-11-04", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1247490\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1268140\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10008 \n\r\n Investigator: Solle, Zdenek \n\n \n\r\n Subject Details \nSubject: CZ100080002 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 04-Nov-2025 12:13:44 \n\r\n Transaction Date/Time (system local): 04-Nov-2025 11:13:44 \n\r\n Transaction performed by: m.deif@clintrial.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..0ff982b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..2de5d68 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 10827, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2025-11-04", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 04-Nov-2025 \n\nDate of Screening in IRT: 04-Nov-2025 \nTransaction Date/Time (site local): 04-Nov-2025 09:21:32\nTransaction Date/Time (system local): 04-Nov-2025 08:21:32\n\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..c09c369 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-04_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.json new file mode 100644 index 0000000..012e098 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 10992, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100120003 has been screen failed at site S10-CZ10012", + "event": "uv_screen_fail", + "actual_date": "2025-11-06", + "subject": "CZ100120003", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120003 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 06-Nov-2025\nTransaction Date/Time (site local): 06-Nov-2025 13:03:37\nTransaction Date/Time (system local): 06-Nov-2025 12:03:37\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..f85e0cb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100120003_has_been_screen_failed_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..5d22355 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11179, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080006 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008", + "event": "DB_P1_V6", + "actual_date": "2025-11-11", + "subject": "CZ100080006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080006 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1047871Seltorexant 20mg or placeboT38028505-Apr-20261121977Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 11-Nov-2025 11:10:51 \nTransaction Date/Time (system local): 11-Nov-2025 10:10:51 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..dcf6bf4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-11_Janssen_42847922MDD3003_Subject_CZ100080006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..e3c5a15 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11267, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 Rolled Over from Part 1 into Part 2 at site S10-CZ10008", + "event": "DB_P1_V7", + "actual_date": "2025-11-12", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 12-Nov-2025 11:17:50\nTransaction Date/Time (system local): 12-Nov-2025 10:17:50\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..4501c6d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json new file mode 100644 index 0000000..da4f744 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11268, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10008", + "event": "DB_P1_V7", + "actual_date": "2025-11-12", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1039446Seltorexant 20mg or placeboT38028505-Apr-20261051859Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 12-Nov-2025 11:17:50 \nTransaction Date/Time (system local): 12-Nov-2025 10:17:50 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..0c3e4d8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-12_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d1127cb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 11404, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10004", + "event": "OL_Ind_V1_5", + "actual_date": "2025-11-14", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100040001 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1204029\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1205609\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1219478\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1243159\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10004 \n\r\n Investigator: Herman, Erik \n\n \n\r\n Subject Details \nSubject: CZ100040001 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 14-Nov-2025 08:49:41 \n\r\n Transaction Date/Time (system local): 14-Nov-2025 07:49:41 \n\r\n Transaction performed by: gnovotna@email.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..cdd3fea Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..cc24045 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11410, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2025-11-14", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 14-Nov-2025 \n\nDate of Screening in IRT: 14-Nov-2025 \nTransaction Date/Time (site local): 14-Nov-2025 10:17:16\nTransaction Date/Time (system local): 14-Nov-2025 09:17:16\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..69f0e19 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..96892f1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11628, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-11-18", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1244960\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1245867\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1247058\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1291625\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 18-Nov-2025 12:51:23\n\nTransaction Date/Time (system local): 18-Nov-2025 11:51:23 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..c56b7aa Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..6485b76 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11627, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.6 at site S10-CZ10008", + "event": "OL_Ind_V1_6", + "actual_date": "2025-11-18", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.6:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1244960\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1245867\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1247058\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1291625\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10008 \n\r\n Investigator: Solle, Zdenek \n\n \n\r\n Subject Details \nSubject: CZ100080002 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 18-Nov-2025 12:49:42 \n\r\n Transaction Date/Time (system local): 18-Nov-2025 11:49:42 \n\r\n Transaction performed by: v.smidkova@clintrial.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..231e832 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..ee169db --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 11620, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10008", + "event": "OL_Ind_V1_1", + "actual_date": "2025-11-18", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1223095Seltorexant 20mgT37484802-May-20261241228Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 18-Nov-2025 11:20:14 \nTransaction Date/Time (system local): 18-Nov-2025 10:20:14 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..8ebe499 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-18_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.json new file mode 100644 index 0000000..e15e330 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11865, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100110005 has been screen failed at site S10-CZ10011", + "event": "uv_screen_fail", + "actual_date": "2025-11-20", + "subject": "CZ100110005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110005 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 20-Nov-2025\nTransaction Date/Time (site local): 20-Nov-2025 20:50:49\nTransaction Date/Time (system local): 20-Nov-2025 19:50:49\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..25b7d80 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-20_Janssen_42847922MDD3003_Subject_CZ100110005_has_been_screen_failed_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..527808b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12039, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1019782\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1020699\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:40:30 \nTransaction Date/Time (system local): 25-Nov-2025 07:40:30 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..3dbee16 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.json new file mode 100644 index 0000000..3d84436 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.json @@ -0,0 +1,10 @@ +{ + "pk": 12040, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1043808\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1056387\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:41:28 \nTransaction Date/Time (system local): 25-Nov-2025 07:41:28 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.pdf new file mode 100644 index 0000000..76dc7e6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12040.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.json new file mode 100644 index 0000000..47a2293 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.json @@ -0,0 +1,10 @@ +{ + "pk": 12041, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1003030\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1186247\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:42:34 \nTransaction Date/Time (system local): 25-Nov-2025 07:42:34 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.pdf new file mode 100644 index 0000000..066af2c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12041.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.json new file mode 100644 index 0000000..c2ea4ca --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.json @@ -0,0 +1,10 @@ +{ + "pk": 12042, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1206881\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1299156\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:43:53 \nTransaction Date/Time (system local): 25-Nov-2025 07:43:53 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.pdf new file mode 100644 index 0000000..1d2cf90 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12042.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.json new file mode 100644 index 0000000..5fccf40 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.json @@ -0,0 +1,10 @@ +{ + "pk": 12043, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1263293\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1284662\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:44:38 \nTransaction Date/Time (system local): 25-Nov-2025 07:44:38 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.pdf new file mode 100644 index 0000000..9d445b9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12043.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.json new file mode 100644 index 0000000..0cb55ac --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.json @@ -0,0 +1,10 @@ +{ + "pk": 12044, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1247490\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1268140\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:45:28 \nTransaction Date/Time (system local): 25-Nov-2025 07:45:28 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.pdf new file mode 100644 index 0000000..7fdff0c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008_pk12044.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2f2b91f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12045, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080004 has been performed.\nMedication ID: 1076269\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1094935\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:47:43 \nTransaction Date/Time (system local): 25-Nov-2025 07:47:43 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..e7758ff Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.json new file mode 100644 index 0000000..b94fa58 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.json @@ -0,0 +1,10 @@ +{ + "pk": 12046, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080004 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080004", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080004 has been performed.\nMedication ID: 1113623\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1192373\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:50:00 \nTransaction Date/Time (system local): 25-Nov-2025 07:50:00 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.pdf new file mode 100644 index 0000000..2bcc10f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080004_has_returned_a_medication_at_site_S10-CZ10008_pk12046.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..9b268fd --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12048, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1148249\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1123910\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:51:11 \nTransaction Date/Time (system local): 25-Nov-2025 07:51:11 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..60118c0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.json new file mode 100644 index 0000000..2f92f09 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.json @@ -0,0 +1,10 @@ +{ + "pk": 12050, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1018200\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nMedication ID: 1017229\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:53:08 \nTransaction Date/Time (system local): 25-Nov-2025 07:53:08 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.pdf new file mode 100644 index 0000000..5e583cf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12050.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.json new file mode 100644 index 0000000..5a961ac --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.json @@ -0,0 +1,10 @@ +{ + "pk": 12052, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1051859\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 10\n\nMedication ID: 1039446\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 4\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Nov-2025 08:55:12 \nTransaction Date/Time (system local): 25-Nov-2025 07:55:12 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.pdf new file mode 100644 index 0000000..1830288 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008_pk12052.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..8c230d9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12073, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 randomized into Part 1 at site S10-CZ10011", + "event": "Rand", + "actual_date": "2025-11-25", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1017917Seltorexant 20mg or placeboT38028505-Apr-20261027330Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 25-Nov-2025 12:13:13\nTransaction Date/Time (system local): 25-Nov-2025 11:13:13\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..0793725 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..3a027cf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12480, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-12-03", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1200865\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1228529\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Dec-2025 10:43:06\n\nTransaction Date/Time (system local): 03-Dec-2025 09:43:06 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..705cb04 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json new file mode 100644 index 0000000..af30811 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12479, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10008", + "event": "OL_Ind_V1_4", + "actual_date": "2025-12-03", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1200865Seltorexant 20mgT37484802-May-20261228529Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Dec-2025 10:41:20 \nTransaction Date/Time (system local): 03-Dec-2025 09:41:20 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..70d7af4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2d4bceb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12474, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-12-03", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1223095\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1241228\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Dec-2025 09:47:11 \nTransaction Date/Time (system local): 03-Dec-2025 08:47:11 \nTransaction performed by: b.sollova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..455cd18 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-03_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json new file mode 100644 index 0000000..e4b1b99 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12914, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011", + "event": "DB_P1_V6", + "actual_date": "2025-12-10", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1079822Seltorexant 20mg or placeboT38028505-Apr-20261151515Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 10-Dec-2025 13:24:09 \nTransaction Date/Time (system local): 10-Dec-2025 12:24:09 \nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..76a80cd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-10_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..73b8611 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13000, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-11", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1012402\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 11-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1114183\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 11-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 11-Dec-2025 10:40:17\n\nTransaction Date/Time (system local): 11-Dec-2025 09:40:17 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..a47f6e6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.json new file mode 100644 index 0000000..f2e6e9a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.json @@ -0,0 +1,10 @@ +{ + "pk": 14220, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-11", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1061445\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1142746\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Jan-2026 12:43:07\n\nTransaction Date/Time (system local): 05-Jan-2026 11:43:07 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.pdf new file mode 100644 index 0000000..c916925 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk14220.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c6e624b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12998, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 randomized into Part 1 at site S10-CZ10011", + "event": "Rand", + "actual_date": "2025-12-11", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1012402Seltorexant 20mg or placeboT38028505-Apr-20261114183Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 11-Dec-2025 09:19:08\nTransaction Date/Time (system local): 11-Dec-2025 08:19:08\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..37e39b5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-11_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..3fd1b6f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13088, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10004", + "event": "OL_TS_V2_2", + "actual_date": "2025-12-12", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1203972Seltorexant 20mgT37484802-May-20261290416Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 12-Dec-2025 09:53:32 \nTransaction Date/Time (system local): 12-Dec-2025 08:53:32 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..5fd922f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ec5e0a1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13157, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-12-15", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1243159\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1219478\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1205609\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1204029\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1290416\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 12-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1203972\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 12-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 15-Dec-2025 09:27:38\n\nTransaction Date/Time (system local): 15-Dec-2025 08:27:38 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c659139 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..08bc444 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13158, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-12-15", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1267690\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1222097\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1243159\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1219478\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1205609\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1204029\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 15-Dec-2025 09:29:19 \nTransaction Date/Time (system local): 15-Dec-2025 08:29:19 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..66b8438 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..54fd9ce --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13248, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-12-16", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1212935\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1231127\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Dec-2025 12:37:17\n\nTransaction Date/Time (system local): 16-Dec-2025 11:37:17 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..bac748b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..7035984 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13247, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10008", + "event": "OL_TS_V2_2", + "actual_date": "2025-12-16", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1212935Seltorexant 20mgT37484802-May-20261231127Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Dec-2025 12:35:02 \nTransaction Date/Time (system local): 16-Dec-2025 11:35:02 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..d52b64e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..b66a83b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13245, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-12-16", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1244960\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1245867\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1247058\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1291625\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Dec-2025 11:32:46 \nTransaction Date/Time (system local): 16-Dec-2025 10:32:46 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..3f7567c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-16_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..ab6ad27 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13313, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-12-17", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1294294\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1251716\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Dec-2025 11:31:17\n\nTransaction Date/Time (system local): 17-Dec-2025 10:31:17 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..a720579 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json new file mode 100644 index 0000000..644392b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13311, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10008", + "event": "OL_Ind_V1_5", + "actual_date": "2025-12-17", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100080005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1251716\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1294294\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10008 \n\r\n Investigator: Solle, Zdenek \n\n \n\r\n Subject Details \nSubject: CZ100080005 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 17-Dec-2025 11:30:16 \n\r\n Transaction Date/Time (system local): 17-Dec-2025 10:30:16 \n\r\n Transaction performed by: v.smidkova@clintrial.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..b5f8dbc Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..8c0c068 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 13315, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-12-17", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1200865\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1228529\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Dec-2025 11:42:13 \nTransaction Date/Time (system local): 17-Dec-2025 10:42:13 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..3d51c3d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..723ba94 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13625, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 Rolled Over from Part 1 into Part 2 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2025-12-22", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Dec-2025 12:51:43\nTransaction Date/Time (system local): 22-Dec-2025 11:51:43\n\nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..85af5e7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json new file mode 100644 index 0000000..b78a464 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13626, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2025-12-22", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1163610Seltorexant 20mg or placeboT38028505-Apr-20261190630Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Dec-2025 12:51:43 \nTransaction Date/Time (system local): 22-Dec-2025 11:51:43 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8c84e59 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..db166b1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13605, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-22", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1016885\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1087214\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Dec-2025 10:29:08\n\nTransaction Date/Time (system local): 22-Dec-2025 09:29:08 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..c170055 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.json new file mode 100644 index 0000000..3468fca --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.json @@ -0,0 +1,10 @@ +{ + "pk": 15012, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-22", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1219416\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1277219\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Jan-2026 10:25:38\n\nTransaction Date/Time (system local): 16-Jan-2026 09:25:38 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.pdf new file mode 100644 index 0000000..fe56fdf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk15012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json new file mode 100644 index 0000000..4f622ae --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13593, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011", + "event": "DB_P1_V6", + "actual_date": "2025-12-22", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1016885Seltorexant 20mg or placeboT38028505-Apr-20261087214Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Dec-2025 09:42:12 \nTransaction Date/Time (system local): 22-Dec-2025 08:42:12 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..0cf6959 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..a136544 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13604, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-12-22", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1012402\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1114183\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 6\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Dec-2025 10:28:40 \nTransaction Date/Time (system local): 22-Dec-2025 09:28:40 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..75c34e2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.json new file mode 100644 index 0000000..b311525 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.json @@ -0,0 +1,10 @@ +{ + "pk": 14219, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-12-22", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1016885\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1087214\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Jan-2026 12:42:26 \nTransaction Date/Time (system local): 05-Jan-2026 11:42:26 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.pdf new file mode 100644 index 0000000..c6e12bb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-22_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011_pk14219.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ca34efa --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13969, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10004", + "event": "OL_TS_V2_3", + "actual_date": "2025-12-29", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1213318Seltorexant 20mgT37484802-May-20261279535Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Dec-2025 14:00:19 \nTransaction Date/Time (system local): 29-Dec-2025 13:00:19 \nTransaction performed by: erik.herman@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..11cf6a0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-29_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..cab729e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14059, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-12-30", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1246473\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1258016\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 30-Dec-2025 11:54:26\n\nTransaction Date/Time (system local): 30-Dec-2025 10:54:26 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..c28b089 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.json new file mode 100644 index 0000000..ca7f3f7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14058, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10008", + "event": "OL_TS_V2_3", + "actual_date": "2025-12-30", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1246473Seltorexant 20mgT37484802-May-20261258016Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 30-Dec-2025 11:53:17 \nTransaction Date/Time (system local): 30-Dec-2025 10:53:17 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..7923eda Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..24ce6c1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14053, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-12-30", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1212935\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1231127\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 30-Dec-2025 11:29:27 \nTransaction Date/Time (system local): 30-Dec-2025 10:29:27 \nTransaction performed by: b.sollova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..504410d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..a97ba3a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14040, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Open Label Induction Visit 1.6 at site S10-CZ10008", + "event": "OL_Ind_V1_6", + "actual_date": "2025-12-30", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100080005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.6:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1218190\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1287807\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10008 \n\r\n Investigator: Solle, Zdenek \n\n \n\r\n Subject Details \nSubject: CZ100080005 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 30-Dec-2025 10:17:33 \n\r\n Transaction Date/Time (system local): 30-Dec-2025 09:17:33 \n\r\n Transaction performed by: m.deif@clintrial.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..4409230 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2b01137 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14033, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-12-30", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1251716\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1294294\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 30-Dec-2025 09:04:37 \nTransaction Date/Time (system local): 30-Dec-2025 08:04:37 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..ea0bfa4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..8a4ca53 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 14210, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 Rolled Over from Part 1 into Part 2 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2026-01-05", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Jan-2026 11:58:47\nTransaction Date/Time (system local): 05-Jan-2026 10:58:47\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..2a7b6d5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json new file mode 100644 index 0000000..7779700 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 14211, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2026-01-05", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1061445Seltorexant 20mg or placeboT38028505-Apr-20261142746Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Jan-2026 11:58:46 \nTransaction Date/Time (system local): 05-Jan-2026 10:58:46 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8d6a6be Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-05_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..e4bc6bb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 14277, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10011", + "event": "OL_Ind_V1_1", + "actual_date": "2026-01-06", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1241496Seltorexant 20mgT37484802-May-20261257075Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 06-Jan-2026 10:21:18 \nTransaction Date/Time (system local): 06-Jan-2026 09:21:18 \nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..5d5272e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-06_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..90d8557 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 14579, + "title": "Randomized_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 randomized into Part 2 at site S10-CZ10004", + "event": "DB_Main_V3_1", + "actual_date": "2026-01-09", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been randomized into Part 2.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1016532Seltorexant 20mg or placeboT38028505-Apr-20261043501Seltorexant 20mg or placeboT38650424-Jun-20281070812Seltorexant 20mg or placeboT38028505-Apr-20261098750Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Jan-2026 10:17:56\nTransaction Date/Time (system local): 09-Jan-2026 09:17:56\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..d58fa22 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040001_randomized_into_Part_2_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..12294d8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 14735, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-01-12", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1203972\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1290416\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 0\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 12-Jan-2026 20:08:04 \nTransaction Date/Time (system local): 12-Jan-2026 19:08:04 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..b69694e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..7ef6595 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14772, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-01-13", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1005098\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1096393\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1009070\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1038016\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-Jan-2026 13:23:11\n\nTransaction Date/Time (system local): 13-Jan-2026 12:23:11 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..bf1a8b6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..a7a1ac9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14770, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-01-13", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1246473\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1258016\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 13-Jan-2026 11:29:42 \nTransaction Date/Time (system local): 13-Jan-2026 10:29:42 \nTransaction performed by: b.sollova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..b96e194 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..95e7739 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14771, + "title": "Randomized_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 randomized into Part 2 at site S10-CZ10008", + "event": "DB_Main_V3_1", + "actual_date": "2026-01-13", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been randomized into Part 2.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1005098Seltorexant 20mg or placeboT38028505-Apr-20261009070Seltorexant 20mg or placeboT38028505-Apr-20261038016Seltorexant 20mg or placeboT38028505-Apr-20261096393Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-Jan-2026 13:09:07\nTransaction Date/Time (system local): 13-Jan-2026 12:09:07\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..389e878 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-13_Janssen_42847922MDD3003_Subject_CZ100080002_randomized_into_Part_2_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..9de816a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14847, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-01-14", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1218190\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1287807\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 14-Jan-2026 11:11:28\n\nTransaction Date/Time (system local): 14-Jan-2026 10:11:28 \nTransaction performed by: zdenek.solle@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..a2586ba Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json new file mode 100644 index 0000000..c0d1565 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 16946, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been discontinued from IRT managed treatment at site S10-CZ10008", + "event": "uv_discontinue", + "actual_date": "2026-01-14", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100080005 has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 14-Jan-2026 \nTransaction Date/Time (site local): 18-Feb-2026 14:33:25\nTransaction Date/Time (system local): 18-Feb-2026 13:33:25\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..f8d2098 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..12d9658 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 14848, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080005 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-01-14", + "subject": "CZ100080005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080005 has been performed.\nMedication ID: 1218190\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1287807\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 14-Jan-2026 11:13:15 \nTransaction Date/Time (system local): 14-Jan-2026 10:13:15 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..283bb88 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-14_Janssen_42847922MDD3003_Subject_CZ100080005_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..51437e2 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15005, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10011", + "event": "OL_Ind_V1_1", + "actual_date": "2026-01-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1219416Seltorexant 20mgT37484802-May-20261277219Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Jan-2026 09:10:05 \nTransaction Date/Time (system local): 16-Jan-2026 08:10:05 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..73142e1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..09fadfd --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15011, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-01-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1061445\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 6\n\nMedication ID: 1142746\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Jan-2026 10:25:01 \nTransaction Date/Time (system local): 16-Jan-2026 09:25:01 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d6d789f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..bcf8db3 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15215, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-01-20", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1291073\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1293256\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1241496\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1257075\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1163610\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1190630\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1079822\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1151515\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1017917\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1027330\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Jan-2026 11:23:31\n\nTransaction Date/Time (system local): 20-Jan-2026 10:23:31 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..bbaedce Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json new file mode 100644 index 0000000..33df0b9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15214, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10011", + "event": "OL_Ind_V1_4", + "actual_date": "2026-01-20", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1291073Seltorexant 20mgT37484802-May-20261293256Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Jan-2026 10:44:10 \nTransaction Date/Time (system local): 20-Jan-2026 09:44:10 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d02bf32 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..6f3440b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15216, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-01-20", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110006 has been performed.\nMedication ID: 1241496\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1257075\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1163610\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1190630\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1079822\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 5\n\nMedication ID: 1151515\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1017917\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1027330\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Jan-2026 11:27:01 \nTransaction Date/Time (system local): 20-Jan-2026 10:27:01 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..638baf6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-20_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..2a2ff1a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15433, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110009 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2026-01-21", + "subject": "CZ100110009", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110009 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110009 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 21-Jan-2026 \n\nDate of Screening in IRT: 21-Jan-2026 \nTransaction Date/Time (site local): 22-Jan-2026 15:39:04\nTransaction Date/Time (system local): 22-Jan-2026 14:39:04\n\nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..20335f5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-21_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.json new file mode 100644 index 0000000..bc51a08 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 15725, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been screened at site S10-CZ10012", + "event": "Screen", + "actual_date": "2026-01-28", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 28-Jan-2026 \n\nDate of Screening in IRT: 28-Jan-2026 \nTransaction Date/Time (site local): 28-Jan-2026 16:24:04\nTransaction Date/Time (system local): 28-Jan-2026 15:24:04\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..9265b0c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-01-28_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_screened_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..6924ab5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16020, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-02-02", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1214847\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 02-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1235803\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 02-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Feb-2026 18:28:47\n\nTransaction Date/Time (system local): 02-Feb-2026 17:28:47 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..e3eb0de Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c5bd17f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15974, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10011", + "event": "OL_Ind_V1_4", + "actual_date": "2026-02-02", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1214847Seltorexant 20mgT37484802-May-20261235803Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Feb-2026 12:21:38 \nTransaction Date/Time (system local): 02-Feb-2026 11:21:38 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..e9fd835 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..920f7fc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16019, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-02-02", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1219416\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 0\n\nMedication ID: 1277219\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Feb-2026 18:28:04 \nTransaction Date/Time (system local): 02-Feb-2026 17:28:04 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..fb9ab02 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json new file mode 100644 index 0000000..3e9e365 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16047, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10011", + "event": "OL_Ind_V1_5", + "actual_date": "2026-02-03", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100110006 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1209188\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1235008\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1275774\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1296942\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10011 \n\r\n Investigator: Lendlova, Marta \n\n \n\r\n Subject Details \nSubject: CZ100110006 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Manual\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 03-Feb-2026 11:31:29 \n\r\n Transaction Date/Time (system local): 03-Feb-2026 10:31:29 \n\r\n Transaction performed by: vysztavel@medipa.org\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..b793fc1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d466490 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16302, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Maintenance Visit 3.2 at site S10-CZ10004", + "event": "DB_Main_V3_2", + "actual_date": "2026-02-06", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1014121Seltorexant 20mg or placeboT38650424-Jun-20281070709Seltorexant 20mg or placeboT38650424-Jun-20281124280Seltorexant 20mg or placeboT38650424-Jun-20281162222Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-Feb-2026 12:31:08 \nTransaction Date/Time (system local): 06-Feb-2026 11:31:08 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c2eb1a1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.json new file mode 100644 index 0000000..8837a1b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17514, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100110009 has been screen failed at site S10-CZ10011", + "event": "uv_screen_fail", + "actual_date": "2026-02-06", + "subject": "CZ100110009", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110009 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 06-Feb-2026\nTransaction Date/Time (site local): 27-Feb-2026 12:40:15\nTransaction Date/Time (system local): 27-Feb-2026 11:40:15\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..ecf2146 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-06_Janssen_42847922MDD3003_Subject_CZ100110009_has_been_screen_failed_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..1ecd2fd --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16364, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-02-09", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1014121\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1070709\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1124280\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1162222\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1016532\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1043501\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1070812\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1098750\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1213318\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 29-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1279535\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 29-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Feb-2026 09:14:46\n\nTransaction Date/Time (system local): 09-Feb-2026 08:14:46 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..69a3253 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..40657bb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16365, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-02-09", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1279535\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1213318\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1098750\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1070812\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1043501\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1016532\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Feb-2026 09:16:06 \nTransaction Date/Time (system local): 09-Feb-2026 08:16:06 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e1e8889 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..c137316 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 16446, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-02-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1004752\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1021105\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1050201\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1121600\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Feb-2026 12:04:51\n\nTransaction Date/Time (system local): 10-Feb-2026 11:04:51 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..4747891 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..e71e52b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 16445, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Maintenance Visit 3.2 at site S10-CZ10008", + "event": "DB_Main_V3_2", + "actual_date": "2026-02-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1004752Seltorexant 20mg or placeboT38028505-Apr-20261021105Seltorexant 20mg or placeboT38028505-Apr-20261050201Seltorexant 20mg or placeboT38650424-Jun-20281121600Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Feb-2026 12:03:54 \nTransaction Date/Time (system local): 10-Feb-2026 11:03:54 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..80bcc2b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..cbdc9fa --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 16443, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-02-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1005098\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1009070\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1038016\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1096393\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Feb-2026 11:36:10 \nTransaction Date/Time (system local): 10-Feb-2026 10:36:10 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..82bd6b7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..635c64d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16494, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-02-10", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1209188\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1235008\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1275774\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1296942\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 10-Feb-2026 20:07:06\n\nTransaction Date/Time (system local): 10-Feb-2026 19:07:06 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8649b7e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.json new file mode 100644 index 0000000..5871a92 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.json @@ -0,0 +1,10 @@ +{ + "pk": 16495, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-02-10", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1209188\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1275774\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1296942\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1235008\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1291073\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1293256\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 10-Feb-2026 20:09:09\n\nTransaction Date/Time (system local): 10-Feb-2026 19:09:09 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.pdf new file mode 100644 index 0000000..0dd5fe3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-10_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk16495.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.json new file mode 100644 index 0000000..4f20e7f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 16775, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 randomized into Part 1 at site S10-CZ10012", + "event": "Rand", + "actual_date": "2026-02-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1054383Seltorexant 20mg or placeboT38028505-Apr-20261056791Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 15-Feb-2026 15:56:13\nTransaction Date/Time (system local): 15-Feb-2026 14:56:13\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..aa0aef8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-15_Janssen_42847922MDD3003_Subject_CZ100120005_randomized_into_Part_1_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..9b55619 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16802, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-02-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1224138\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1281712\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Feb-2026 10:46:35\n\nTransaction Date/Time (system local): 16-Feb-2026 09:46:35 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..3e315a2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json new file mode 100644 index 0000000..ccaf1ee --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16797, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10011", + "event": "OL_Ind_V1_5", + "actual_date": "2026-02-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1224138\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1281712\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10011 \n\r\n Investigator: Lendlova, Marta \n\n \n\r\n Subject Details \nSubject: CZ100110007 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 16-Feb-2026 10:20:46 \n\r\n Transaction Date/Time (system local): 16-Feb-2026 09:20:46 \n\r\n Transaction performed by: truhlarova@medipa.org\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..6e6e925 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c29c968 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 16801, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-02-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1214847\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1235803\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Feb-2026 10:45:55 \nTransaction Date/Time (system local): 16-Feb-2026 09:45:55 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..548b9f3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json new file mode 100644 index 0000000..5434a25 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 16855, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-02-17", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1054383\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 15-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1056791\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 15-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 17-Feb-2026 14:05:38\n\nTransaction Date/Time (system local): 17-Feb-2026 13:05:38 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..88886a2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.json new file mode 100644 index 0000000..754a862 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.json @@ -0,0 +1,10 @@ +{ + "pk": 20767, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-02-17", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1213449\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1222242\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Apr-2026 08:25:05\n\nTransaction Date/Time (system local): 17-Apr-2026 06:25:05 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.pdf new file mode 100644 index 0000000..a7f56c7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-17_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20767.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.json new file mode 100644 index 0000000..1faa8ad --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 17546, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10012", + "event": "DB_P1_V6", + "actual_date": "2026-02-27", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1067396Seltorexant 20mg or placeboT38650424-Jun-20281145277Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 27-Feb-2026 17:44:56 \nTransaction Date/Time (system local): 27-Feb-2026 16:44:56 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..5317075 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json new file mode 100644 index 0000000..d2bae72 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 17547, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-02-27", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1054383\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 5\n\nMedication ID: 1056791\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 27-Feb-2026 18:21:41 \nTransaction Date/Time (system local): 27-Feb-2026 17:21:41 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..0c083e3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.json new file mode 100644 index 0000000..62cefc7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.json @@ -0,0 +1,10 @@ +{ + "pk": 19358, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-02-27", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1052405\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1103546\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 5\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Mar-2026 12:21:59 \nTransaction Date/Time (system local): 29-Mar-2026 10:21:59 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.pdf new file mode 100644 index 0000000..6b55b59 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk19358.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.json new file mode 100644 index 0000000..4bdb008 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17607, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Induction Visit 1.6 at site S10-CZ10011", + "event": "OL_Ind_V1_6", + "actual_date": "2026-03-02", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.6:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1231444\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n1265004\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10011 \n\r\n Investigator: Lendlova, Marta \n\n \n\r\n Subject Details \nSubject: CZ100110007 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 02-Mar-2026 11:45:54 \n\r\n Transaction Date/Time (system local): 02-Mar-2026 10:45:54 \n\r\n Transaction performed by: truhlarova@medipa.org\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..4689e04 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..21415a8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17609, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-03-02", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1224138\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1281712\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Mar-2026 12:08:19 \nTransaction Date/Time (system local): 02-Mar-2026 11:08:19 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..433a31d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..4586e83 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17679, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-03-03", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1228400\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1210007\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Mar-2026 11:12:44\n\nTransaction Date/Time (system local): 03-Mar-2026 10:12:44 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..72e2a18 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..21dd78f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17678, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10011", + "event": "OL_TS_V2_2", + "actual_date": "2026-03-03", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1210007Seltorexant 20mgT39247624-Jun-20281228400Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Mar-2026 10:25:07 \nTransaction Date/Time (system local): 03-Mar-2026 09:25:07 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..5c8b420 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-03_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.json new file mode 100644 index 0000000..995f2dc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 17949, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Maintenance Visit 3.3 at site S10-CZ10004", + "event": "DB_Main_V3_3", + "actual_date": "2026-03-06", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1008669Seltorexant 20mg or placeboT38650424-Jun-20281052502Seltorexant 20mg or placeboT38650424-Jun-20281182154Seltorexant 20mg or placeboT38650424-Jun-20281199540Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-Mar-2026 12:13:49 \nTransaction Date/Time (system local): 06-Mar-2026 11:13:49 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..9e0c6f3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..feaba5a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 18032, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-03-09", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1008669\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1052502\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1199540\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1182154\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Mar-2026 11:11:53\n\nTransaction Date/Time (system local): 09-Mar-2026 10:11:53 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..104ad15 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d983791 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 18033, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-03-09", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1014121\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1070709\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1124280\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1162222\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Mar-2026 11:12:49 \nTransaction Date/Time (system local): 09-Mar-2026 10:12:49 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c504f05 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..ed35abe --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 18136, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-03-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1067238\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1086247\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1181079\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1181089\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Mar-2026 12:33:55\n\nTransaction Date/Time (system local): 10-Mar-2026 11:33:55 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..8f9e662 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.json new file mode 100644 index 0000000..1e47670 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 18135, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Maintenance Visit 3.3 at site S10-CZ10008", + "event": "DB_Main_V3_3", + "actual_date": "2026-03-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1067238Seltorexant 20mg or placeboT38650424-Jun-20281086247Seltorexant 20mg or placeboT38650424-Jun-20281181079Seltorexant 20mg or placeboT38650424-Jun-20281181089Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Mar-2026 12:32:23 \nTransaction Date/Time (system local): 10-Mar-2026 11:32:23 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..e8c1e2b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..02aeb3b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 18138, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-03-10", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1004752\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1021105\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1050201\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1121600\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 10-Mar-2026 12:36:15 \nTransaction Date/Time (system local): 10-Mar-2026 11:36:15 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..05570e1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-10_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.json new file mode 100644 index 0000000..a143c86 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 18416, + "title": "No_Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 Completed Part 1 will not rollover into Part 2 at site S10-CZ10012", + "event": "DB_P1_V7", + "actual_date": "2026-03-13", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has completed part 1 and will not roll over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 13-Mar-2026 15:41:48\nTransaction Date/Time (system local): 13-Mar-2026 14:41:48\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..e1bfb92 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.json new file mode 100644 index 0000000..273a88a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 18417, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10012", + "event": "DB_P1_V7", + "actual_date": "2026-03-13", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1052405Seltorexant 20mg or placeboT38650424-Jun-20281103546Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 13-Mar-2026 15:41:47 \nTransaction Date/Time (system local): 13-Mar-2026 14:41:47 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..a0f1ca3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-13_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json new file mode 100644 index 0000000..59ab7d1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 18454, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1145277\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1067396\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 15-Mar-2026 11:47:24\n\nTransaction Date/Time (system local): 15-Mar-2026 10:47:24 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..edd8eb4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.json new file mode 100644 index 0000000..32082aa --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.json @@ -0,0 +1,10 @@ +{ + "pk": 18456, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1103546\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1052405\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 15-Mar-2026 11:48:23\n\nTransaction Date/Time (system local): 15-Mar-2026 10:48:23 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.pdf new file mode 100644 index 0000000..e70f9da Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk18456.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.json new file mode 100644 index 0000000..ab439cc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.json @@ -0,0 +1,10 @@ +{ + "pk": 20768, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1237013\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1241196\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Apr-2026 08:26:08\n\nTransaction Date/Time (system local): 17-Apr-2026 06:26:08 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.pdf new file mode 100644 index 0000000..8323a4e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk20768.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.json new file mode 100644 index 0000000..ccb54d9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.json @@ -0,0 +1,10 @@ +{ + "pk": 21110, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1213449\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1222242\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 22-Apr-2026 16:17:03\n\nTransaction Date/Time (system local): 22-Apr-2026 14:17:03 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.pdf new file mode 100644 index 0000000..9c631e8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012_pk21110.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json new file mode 100644 index 0000000..5e60862 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 18455, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1067396\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1145277\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 15-Mar-2026 11:47:57 \nTransaction Date/Time (system local): 15-Mar-2026 10:47:57 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..d9d3fbe Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.json new file mode 100644 index 0000000..14ce78a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.json @@ -0,0 +1,10 @@ +{ + "pk": 21349, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-03-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1213449\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nMedication ID: 1222242\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 26-Apr-2026 11:41:48 \nTransaction Date/Time (system local): 26-Apr-2026 09:41:48 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.pdf new file mode 100644 index 0000000..61b53f1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012_pk21349.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..839e582 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 18470, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-03-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1231444\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 02-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1265004\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 02-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Mar-2026 11:05:08\n\nTransaction Date/Time (system local): 16-Mar-2026 10:05:08 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..a683ced Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.json new file mode 100644 index 0000000..b417a59 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.json @@ -0,0 +1,10 @@ +{ + "pk": 18472, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-03-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1205166\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1229581\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1250166\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1261027\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 16-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Mar-2026 11:07:11\n\nTransaction Date/Time (system local): 16-Mar-2026 10:07:11 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.pdf new file mode 100644 index 0000000..0bb1003 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk18472.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.json new file mode 100644 index 0000000..5c3285f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 18466, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Induction Visit 1.7 at site S10-CZ10011", + "event": "OL_Ind_V1_7", + "actual_date": "2026-03-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.7:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1205166\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n1229581\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n1250166\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n1261027\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10011 \n\r\n Investigator: Lendlova, Marta \n\n \n\r\n Subject Details \nSubject: CZ100110007 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 16-Mar-2026 10:09:50 \n\r\n Transaction Date/Time (system local): 16-Mar-2026 09:09:50 \n\r\n Transaction performed by: truhlarova@medipa.org\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..28271f6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.7_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..33a51c9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 18471, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-03-16", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1231444\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1265004\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 16-Mar-2026 11:06:12 \nTransaction Date/Time (system local): 16-Mar-2026 10:06:12 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..c561994 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-16_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c506249 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 18531, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10011", + "event": "OL_TS_V2_3", + "actual_date": "2026-03-17", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1205393Seltorexant 20mgT39247624-Jun-20281215203Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Mar-2026 10:19:05 \nTransaction Date/Time (system local): 17-Mar-2026 09:19:05 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..69634f9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-17_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.json new file mode 100644 index 0000000..0eae365 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 19140, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10012", + "event": "OL_Ind_V1_1", + "actual_date": "2026-03-25", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1237013Seltorexant 20mgT39247624-Jun-20281241196Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-Mar-2026 16:32:29 \nTransaction Date/Time (system local): 25-Mar-2026 15:32:29 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..0d99783 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..06fa72b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 19481, + "title": "Randomized_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 randomized into Part 2 at site S10-CZ10011", + "event": "DB_Main_V3_1", + "actual_date": "2026-03-31", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been randomized into Part 2.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1105798Seltorexant 20mg or placeboT38650424-Jun-20281151419Seltorexant 20mg or placeboT38650424-Jun-20281181446Seltorexant 20mg or placeboT38650424-Jun-20281187419Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 31-Mar-2026 11:47:30\nTransaction Date/Time (system local): 31-Mar-2026 09:47:30\nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..1948bc0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-03-31_Janssen_42847922MDD3003_Subject_CZ100110006_randomized_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.json new file mode 100644 index 0000000..690eb47 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 19920, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Maintenance Visit 3.4 at site S10-CZ10004", + "event": "DB_Main_V3_4", + "actual_date": "2026-04-07", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1013204Seltorexant 20mg or placeboT38650424-Jun-20281034161Seltorexant 20mg or placeboT38650424-Jun-20281130765Seltorexant 20mg or placeboT38650424-Jun-20281139849Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 09:48:25 \nTransaction Date/Time (system local): 07-Apr-2026 07:48:25 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..b8db837 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..14227b8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 19950, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-04-07", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1011219\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1159117\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1188311\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1194723\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 12:11:27\n\nTransaction Date/Time (system local): 07-Apr-2026 10:11:27 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..cfceacf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.json new file mode 100644 index 0000000..4e61361 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 19948, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Maintenance Visit 3.4 at site S10-CZ10008", + "event": "DB_Main_V3_4", + "actual_date": "2026-04-07", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1011219Seltorexant 20mg or placeboT38650424-Jun-20281159117Seltorexant 20mg or placeboT38650424-Jun-20281188311Seltorexant 20mg or placeboT38650424-Jun-20281194723Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 12:08:56 \nTransaction Date/Time (system local): 07-Apr-2026 10:08:56 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..7a28ef3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..b57a72d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 19952, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-04-07", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1067238\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1086247\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1181079\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1181089\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 12:25:40 \nTransaction Date/Time (system local): 07-Apr-2026 10:25:40 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..9c7b576 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..9c60693 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 20027, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-07", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1210007\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1228400\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1235008\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1209188\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 19:51:05\n\nTransaction Date/Time (system local): 07-Apr-2026 17:51:05 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..ad3600f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.json new file mode 100644 index 0000000..dc23dee --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.json @@ -0,0 +1,10 @@ +{ + "pk": 20028, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-07", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1275774\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1296942\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 03-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1291073\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1293256\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 19:51:59\n\nTransaction Date/Time (system local): 07-Apr-2026 17:51:59 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.pdf new file mode 100644 index 0000000..a904fab Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk20028.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..41b4be4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 20139, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-04-08", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110006 has been performed.\nMedication ID: 1210007\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1228400\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1209188\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1235008\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1275774\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1296942\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1291073\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1293256\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 08-Apr-2026 20:58:58 \nTransaction Date/Time (system local): 08-Apr-2026 18:58:58 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..346a834 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.json new file mode 100644 index 0000000..ec1d0f0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 20079, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10012", + "event": "OL_Ind_V1_4", + "actual_date": "2026-04-08", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100120005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1213449Seltorexant 20mgT39247624-Jun-20281222242Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 08-Apr-2026 15:25:43 \nTransaction Date/Time (system local): 08-Apr-2026 13:25:43 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..b57a804 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-08_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..7aa1b9f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20366, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-04-13", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1139849\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1130765\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1034161\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1013204\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-Apr-2026 13:18:35\n\nTransaction Date/Time (system local): 13-Apr-2026 11:18:35 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..ef793d5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..ef361e6 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20367, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-04-13", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1008669\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1052502\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1182154\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1199540\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-Apr-2026 13:20:47 \nTransaction Date/Time (system local): 13-Apr-2026 11:20:47 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c51e2a3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..9403809 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 20434, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-14", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1248593\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1262749\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 14-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 14-Apr-2026 12:53:12\n\nTransaction Date/Time (system local): 14-Apr-2026 10:53:12 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..4f2039f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..9c55ca5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 20430, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10011", + "event": "OL_TS_V2_2", + "actual_date": "2026-04-14", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1248593Seltorexant 20mgT39247624-Jun-20281262749Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 14-Apr-2026 12:38:56 \nTransaction Date/Time (system local): 14-Apr-2026 10:38:56 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..2ddcdd3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..5591c81 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 20433, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-04-14", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1205166\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nMedication ID: 1229581\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1250166\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1261027\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 14-Apr-2026 12:52:32 \nTransaction Date/Time (system local): 14-Apr-2026 10:52:32 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d5c64d2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-14_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json new file mode 100644 index 0000000..55035db --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 21111, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-04-22", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1237013\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1241196\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 22-Apr-2026 16:17:38\n\nTransaction Date/Time (system local): 22-Apr-2026 14:17:38 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..e832606 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.json new file mode 100644 index 0000000..676e49a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 21231, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10012", + "event": "OL_Ind_V1_5", + "actual_date": "2026-04-23", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100120005 has been assigned the following medication(s) for visit Open Label Induction Visit 1.5:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1211059\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n1251709\r\n Seltorexant 20mg\r\n T392476\r\n 24-Jun-2028\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10012 \n\r\n Investigator: Urban, Ales \n\n \n\r\n Subject Details \nSubject: CZ100120005 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 23-Apr-2026 18:07:53 \n\r\n Transaction Date/Time (system local): 23-Apr-2026 16:07:53 \n\r\n Transaction performed by: marcelasedlackova@seznam.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..9ff6124 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-23_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json new file mode 100644 index 0000000..a72d72f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 21348, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 dispensing confirmation has occurred at site S10-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-04-26", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100120005 has\nbeen performed for the following medication IDs:\n\nMedication No: 1211059\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 23-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1251709\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 23-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10012 \nInvestigator: Urban, Ales \n\nSubject Details \nSubject:\nCZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 26-Apr-2026 11:40:50\n\nTransaction Date/Time (system local): 26-Apr-2026 09:40:50 \nTransaction performed by: marcelasedlackova@seznam.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..d036955 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_dispensing_confirmation_has_occurred_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json new file mode 100644 index 0000000..b86007e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 21350, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-04-26", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1237013\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1241196\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 26-Apr-2026 11:42:58 \nTransaction Date/Time (system local): 26-Apr-2026 09:42:58 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..924e4f7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-26_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..09007a3 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21401, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-27", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1226354\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 27-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1283009\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 27-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 27-Apr-2026 13:01:31\n\nTransaction Date/Time (system local): 27-Apr-2026 11:01:31 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..173e738 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json new file mode 100644 index 0000000..185aa02 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21399, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10011", + "event": "OL_TS_V2_3", + "actual_date": "2026-04-27", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1226354Seltorexant 20mgT39247624-Jun-20281283009Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 27-Apr-2026 12:16:24 \nTransaction Date/Time (system local): 27-Apr-2026 10:16:24 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d2f2931 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..f408db0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21400, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-04-27", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1248593\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1262749\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 27-Apr-2026 13:00:30 \nTransaction Date/Time (system local): 27-Apr-2026 11:00:30 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..1da2315 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-27_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.json new file mode 100644 index 0000000..b374303 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 21483, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Maintenance Visit 3.5 at site S10-CZ10004", + "event": "DB_Main_V3_5", + "actual_date": "2026-04-28", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.5:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1148017Seltorexant 20mg or placeboT38650424-Jun-20281155960Seltorexant 20mg or placeboT38650424-Jun-20281172483Seltorexant 20mg or placeboT38650424-Jun-20281197179Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:16:36 \nTransaction Date/Time (system local): 28-Apr-2026 09:16:36 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..db2c95e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..15fc220 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21484, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1105798\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 31-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1151419\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 31-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1181446\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 31-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1187419\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 31-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:19:49\n\nTransaction Date/Time (system local): 28-Apr-2026 09:19:49 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..55fb1c3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.json new file mode 100644 index 0000000..c608427 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.json @@ -0,0 +1,10 @@ +{ + "pk": 21486, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1205393\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1215203\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:28:15\n\nTransaction Date/Time (system local): 28-Apr-2026 09:28:15 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.pdf new file mode 100644 index 0000000..83ac0ef Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21486.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.json new file mode 100644 index 0000000..161137f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.json @@ -0,0 +1,10 @@ +{ + "pk": 21488, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1041432\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1126309\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1159985\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1163542\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:30:26\n\nTransaction Date/Time (system local): 28-Apr-2026 09:30:26 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.pdf new file mode 100644 index 0000000..2dfe522 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk21488.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..9a7d7f5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21471, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Double Blind Maintenance Visit 3.2 at site S10-CZ10011", + "event": "DB_Main_V3_2", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1041432Seltorexant 20mg or placeboT38650424-Jun-20281126309Seltorexant 20mg or placeboT38650424-Jun-20281159985Seltorexant 20mg or placeboT38650424-Jun-20281163542Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 10:08:43 \nTransaction Date/Time (system local): 28-Apr-2026 08:08:43 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8596bc3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..182d45f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 21485, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110006 has been performed.\nMedication ID: 1105798\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1151419\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1181446\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1187419\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:20:56 \nTransaction Date/Time (system local): 28-Apr-2026 09:20:56 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..6a91328 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.json new file mode 100644 index 0000000..0656722 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.json @@ -0,0 +1,10 @@ +{ + "pk": 21487, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-04-28", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110006 has been performed.\nMedication ID: 1205393\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1215203\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 11:29:39 \nTransaction Date/Time (system local): 28-Apr-2026 09:29:39 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.pdf new file mode 100644 index 0000000..243b8b3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011_pk21487.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..fda238d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 21951, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-05-05", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1075021\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1108887\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1187187\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1193010\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 05-May-2026 11:39:36\n\nTransaction Date/Time (system local): 05-May-2026 09:39:36 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..ff80050 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.json new file mode 100644 index 0000000..3292327 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 21950, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Maintenance Visit 3.5 at site S10-CZ10008", + "event": "DB_Main_V3_5", + "actual_date": "2026-05-05", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.5:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1075021Seltorexant 20mg or placeboT38650424-Jun-20281108887Seltorexant 20mg or placeboT38650424-Jun-20281187187Seltorexant 20mg or placeboT38650424-Jun-20281193010Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 05-May-2026 11:38:28 \nTransaction Date/Time (system local): 05-May-2026 09:38:28 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..10f9ca2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.5_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..5fc04cc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 21956, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-05-05", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1194723\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1188311\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1159117\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1011219\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 05-May-2026 12:25:14 \nTransaction Date/Time (system local): 05-May-2026 10:25:14 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..9dd45a4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..2534332 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 22014, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-05-06", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1148017\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1155960\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1172483\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1197179\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-May-2026 07:41:48\n\nTransaction Date/Time (system local): 06-May-2026 05:41:48 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e9bad83 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..3658532 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 22015, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-05-06", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1139849\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 6\n\nMedication ID: 1130765\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1034161\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1013204\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-May-2026 07:45:58 \nTransaction Date/Time (system local): 06-May-2026 05:45:58 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e746839 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..d3cfeb9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 22516, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-05-13", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1053546\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1103948\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1115574\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1183558\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 13-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110007 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-May-2026 12:01:21\n\nTransaction Date/Time (system local): 13-May-2026 10:01:21 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d25aa2d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..e111c92 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 22515, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-05-13", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110007 has been performed.\nMedication ID: 1226354\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1283009\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 1\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-May-2026 12:00:49 \nTransaction Date/Time (system local): 13-May-2026 10:00:49 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..172678d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..57b1718 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 22491, + "title": "Randomized_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110007 randomized into Part 2 at site S10-CZ10011", + "event": "DB_Main_V3_1", + "actual_date": "2026-05-13", + "subject": "CZ100110007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110007 has been randomized into Part 2.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1053546Seltorexant 20mg or placeboT38650424-Jun-20281103948Seltorexant 20mg or placeboT38650424-Jun-20281115574Seltorexant 20mg or placeboT38650424-Jun-20281183558Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110007 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-May-2026 09:02:46\nTransaction Date/Time (system local): 13-May-2026 07:02:46\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..7322a5f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-13_Janssen_42847922MDD3003_Subject_CZ100110007_randomized_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.json new file mode 100644 index 0000000..dd89bbd --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 22756, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has been discontinued from IRT managed treatment at site S10-CZ10012", + "event": "uv_discontinue", + "actual_date": "2026-05-15", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100120005 has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 15-May-2026 \nTransaction Date/Time (site local): 17-May-2026 10:16:14\nTransaction Date/Time (system local): 17-May-2026 08:16:14\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..76ccf1b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-15_Janssen_42847922MDD3003_Subject_CZ100120005_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json new file mode 100644 index 0000000..58b36cd --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 22755, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100120005 has returned a medication at site S10-CZ10012", + "event": "uv_return", + "actual_date": "2026-05-17", + "subject": "CZ100120005", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100120005 has been performed.\nMedication ID: 1211059\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nMedication ID: 1251709\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 10\n\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-May-2026 10:15:15 \nTransaction Date/Time (system local): 17-May-2026 08:15:15 \nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..a5cb771 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-17_Janssen_42847922MDD3003_Subject_CZ100120005_has_returned_a_medication_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..a1d8a7b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 23279, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2026-05-26", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110006 has\nbeen performed for the following medication IDs:\n\nMedication No: 1028124\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1062559\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1126062\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1146132\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 26-May-2026 16:52:01\n\nTransaction Date/Time (system local): 26-May-2026 14:52:01 \nTransaction performed by: vysztavel@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..127d8cc Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.json new file mode 100644 index 0000000..398983e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 23248, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has been assigned medication for visit Double Blind Maintenance Visit 3.3 at site S10-CZ10011", + "event": "DB_Main_V3_3", + "actual_date": "2026-05-26", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110006 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1028124Seltorexant 20mg or placeboT38650424-Jun-20281062559Seltorexant 20mg or placeboT38650424-Jun-20281126062Seltorexant 20mg or placeboT38650424-Jun-20281146132Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 26-May-2026 11:47:04 \nTransaction Date/Time (system local): 26-May-2026 09:47:04 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..2d7339b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..4746d1f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 23278, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110006 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-05-26", + "subject": "CZ100110006", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110006 has been performed.\nMedication ID: 1041432\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1126309\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1159985\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1163542\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110006 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 26-May-2026 16:51:38 \nTransaction Date/Time (system local): 26-May-2026 14:51:38 \nTransaction performed by: vysztavel@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..4599edc Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-26_Janssen_42847922MDD3003_Subject_CZ100110006_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.json new file mode 100644 index 0000000..eaf464e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23328, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Maintenance Visit 3.6 at site S10-CZ10004", + "event": "DB_Main_V3_6", + "actual_date": "2026-05-27", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040001 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1022543Seltorexant 20mg or placeboT38650424-Jun-20281031390Seltorexant 20mg or placeboT38650424-Jun-20281056641Seltorexant 20mg or placeboT38650424-Jun-20281067297Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 27-May-2026 11:32:49 \nTransaction Date/Time (system local): 27-May-2026 09:32:49 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..e2d153b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-05-27_Janssen_42847922MDD3003_Subject_CZ100040001_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..a0f2add --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23654, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-06-01", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1022543\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1031390\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1056641\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1067297\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 27-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 01-Jun-2026 11:42:01\n\nTransaction Date/Time (system local): 01-Jun-2026 09:42:01 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..5910849 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..5857836 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23655, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-06-01", + "subject": "CZ100040001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040001 has been performed.\nMedication ID: 1197179\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 5\n\nMedication ID: 1172483\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1155960\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1148017\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 01-Jun-2026 11:43:38 \nTransaction Date/Time (system local): 01-Jun-2026 09:43:38 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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0000000..79150d4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 23735, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2026-06-02", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1012228\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 02-Jun-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1043353\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 02-Jun-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1088153\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 02-Jun-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1135941\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 02-Jun-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 02-Jun-2026 12:13:40\n\nTransaction Date/Time (system local): 02-Jun-2026 10:13:40 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..a3360b6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..df1dd1b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 23734, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Maintenance Visit 3.6 at site S10-CZ10008", + "event": "DB_Main_V3_6", + "actual_date": "2026-06-02", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1012228Seltorexant 20mg or placeboT38650424-Jun-20281043353Seltorexant 20mg or placeboT38650424-Jun-20281088153Seltorexant 20mg or placeboT38650424-Jun-20281135941Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 02-Jun-2026 12:12:17 \nTransaction Date/Time (system local): 02-Jun-2026 10:12:17 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..6455b52 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.6_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..7d5d874 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 23733, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080002 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2026-06-02", + "subject": "CZ100080002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080002 has been performed.\nMedication ID: 1075021\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1108887\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1187187\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1193010\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 02-Jun-2026 11:44:10 \nTransaction Date/Time (system local): 02-Jun-2026 09:44:10 \nTransaction performed by: zdenek.solle@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..5057a02 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-02_Janssen_42847922MDD3003_Subject_CZ100080002_has_returned_a_medication_at_site_S10-CZ10008.pdf differ