From f11d407b7326bcf3da8219646a52f33c20d799c7 Mon Sep 17 00:00:00 2001 From: "vladimir.buzalka" Date: Tue, 2 Jun 2026 17:29:41 +0200 Subject: [PATCH] z230 --- ... 42847922MDD3003 Subject Summary Report.xlsx | Bin 0 -> 10209 bytes ...2_has_been_screened_at_site_S10-CZ10008.json | 10 ++++++++++ ...02_has_been_screened_at_site_S10-CZ10008.pdf | Bin 0 -> 23749 bytes ...1_has_been_screened_at_site_S10-CZ10004.json | 10 ++++++++++ ...01_has_been_screened_at_site_S10-CZ10004.pdf | Bin 0 -> 23784 bytes ...mation_has_occurred_at_site_S10-CZ10008.json | 10 ++++++++++ ...rmation_has_occurred_at_site_S10-CZ10008.pdf | Bin 0 -> 24877 bytes ...has_occurred_at_site_S10-CZ10008_pk8785.json | 10 ++++++++++ ..._has_occurred_at_site_S10-CZ10008_pk8785.pdf | Bin 0 -> 24671 bytes ...domized_into_Part_1_at_site_S10-CZ10008.json | 10 ++++++++++ ...ndomized_into_Part_1_at_site_S10-CZ10008.pdf | Bin 0 -> 24968 bytes ...4_has_been_screened_at_site_S10-CZ10008.json | 10 ++++++++++ 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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 0000000000000000000000000000000000000000..d7abb340219e05d5793fa5ac30f63471f3f4c9d7 GIT binary patch literal 23784 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/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 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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 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HcmV?d00001 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 0000000000000000000000000000000000000000..088ed8f6d20210ba48bedcd46db0855cedf611ef GIT binary patch literal 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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 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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: 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"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 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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: 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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 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HcmV?d00001 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 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"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 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"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 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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 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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 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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 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"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 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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: 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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 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"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 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/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: 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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 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"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 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"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 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@@ +{ + "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 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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 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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 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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 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"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 0000000000000000000000000000000000000000..ea3741e9387896a797d7badf85584f8aff9ab3c4 GIT binary patch literal 24952 zcmce71yo$m(kF!A4#9#=aF@Z|J-E9L1oz->fgr(yyMzG2o!}5WxVyUr3AzLP?Y-~q ze&3!wXJ^j6ZPnG)RbAbEZ~rd2f~Yt>GXpCEGk^(TYh;1I%ZtFMV(w%G0#MyQP$Mvk zIDibDY#km`5H1jw5bq$IAgm#*z;{~+I|vg9QwRVA69fYUGXxNPXMc==YbiL`nm8MS zo~tQ>i2)F-;37`&#qlRob6XoxLnm-MqTE0xAUhK~6Ofq=$j;29MUBAEj{veUd6b9c 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/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 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"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 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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 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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 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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 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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 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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? 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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 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"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 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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 0000000000000000000000000000000000000000..1d2cf90e57c5c091380021d551ac278c35191954 GIT binary patch literal 24491 zcmce-1yo$k(l!bt1ef5>1PHD(gIkcG!QFLmAKW!a0t654!Gk1dfZzm&;BG+z!JQ!g z0C~^*p7Wh`zyGeg)}2|iyLWe0b#+yDb?@nCKUWl&VBuf|qjCV)0rtjLr~(40Y^s*d 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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 0000000000000000000000000000000000000000..9d445b9297ae935dd985b908e569f085ab5d7fc5 GIT binary patch literal 24381 zcmce-1yo$i(mzUY36|hGNN^q8-QC?8++7mf-3d;R5ZnTU;2tEn2M7`%xVyapa_%|z 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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 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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 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--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 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"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 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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 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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 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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 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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: 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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 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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 0000000000000000000000000000000000000000..37e39b581dc08161f7304eacb6e6c98f96fc4d04 GIT binary patch literal 24918 zcmce-1yo(j(m#l6a1DBb1$Q~PySux)ySqbz1%g9x5AF^L5G28ZI|P^DHV4Rk_rCYN zneRVq)|zwH-fdOY)m`1Sd++`=xq^ro9TPn(0uz7{U~goFz{7*UpknD_V+x>rc%(vL z5Oy*(bg_4ON`bk9S%X=Cxq#V%*?{i$U=Cm=U}j(dFh($XFeWf&(4GA$2I5k1vNv%x 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"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 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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 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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 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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 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"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 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-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 0000000000000000000000000000000000000000..c17005549dd6ed26069096920d0b98a936abaa4f GIT binary patch literal 24751 zcmce81ymi+(&r@!!Gb$ME>3WFm*DOYoQu0V1oz+sClG?WYjA=~(BST_LH7cGd+&R@ 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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 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HcmV?d00001 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 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VyW>N5ZfT%?q%u1MqHk`%{$ELDXN~{> literal 0 HcmV?d00001 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 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"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 0000000000000000000000000000000000000000..c28b0897b70116d8f5bc04d50a2f2beed61cbbab GIT binary patch literal 25006 zcmce71yo$m(kGDM?h<4mXz;<^gM0Ac3R-Smj zB6c8s2Wz{>D+p%@bBGTR4iJ_Q7T{lN2pb3^2xABU1QP@U1TzE>{LB8B19K_ZSsOVT zf}YtF!NdRvR&W(3_{;I9P*ZCwQGEw+JEGh`CLlW#I}?zZ4am&Orb&aq&yN7IGJ4d9 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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 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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 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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 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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 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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 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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 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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 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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: 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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, 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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 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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 0000000000000000000000000000000000000000..f8d20987ef043e7213a0d2e3dbbb3beeb59333db GIT binary patch literal 24456 zcmce-1ymi)(l&|(2yO`uI|TQ=aS!h9?(Xgo+%3U_LvRZY!Gb#^xH|-g5ZwL^;?@89_i65E~P_1{DG?FM_d+ 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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: 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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: 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/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 0000000000000000000000000000000000000000..d6d789f173998306c0c48274a2a07a9937bf9a71 GIT binary patch literal 24490 zcmce-1yo$k(l&~O5L|=H;O>K4aCdhd+y{3E1PKy?ySqb3fZ!S+xJ%Fg0fIx2ApZb) z&-dqdut<2iN~yU*I1yRYL;$WXZVw3s04p;qJ0gpj34o266{5Dt(^W)9 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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 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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 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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 0000000000000000000000000000000000000000..638baf68a2d65470981b894dabe2ca04c399335a GIT binary patch literal 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literal 0 HcmV?d00001 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 0000000000000000000000000000000000000000..20335f5e975e1ee6f4c3a4dd0a3baf49e11876e4 GIT binary 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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 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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 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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 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"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 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M%MOESp44Lh7d?YC&j0`b literal 0 HcmV?d00001 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? 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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 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Gp??9=mMKaA literal 0 HcmV?d00001 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 0000000000000000000000000000000000000000..69a3253ff749203ad5168a54ec9432c92c88663f GIT binary patch literal 27309 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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 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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 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"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 0000000000000000000000000000000000000000..8649b7ef438161064dee628084533918a2b28c37 GIT binary patch literal 25102 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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): 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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 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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 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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 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"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 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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 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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 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"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 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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 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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 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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: 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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 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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 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"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 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"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 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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 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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 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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" +} 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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 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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 0000000000000000000000000000000000000000..28271f68f59869161952d166318553b74c1856de GIT binary patch literal 25940 zcmce-1yo(jvM7oZAVGozXAzv>?(XjHuy9|vy95itouI+pB|wk_4KBgmo#5duAp7in 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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 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"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 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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 0000000000000000000000000000000000000000..b8db83780af28bb3653cbab43dee45cd3aed5853 GIT binary patch literal 25855 zcmce-1yr2P(l7`iNN@`fbRcL5HZX&`JHaJDaCdhI?jgZ71b24`4uK%S-7UDg?Erc2 z``-KA-S6MC=j_axX{)NPuIjFS`spePIUx}`CVCb`CIBPAO4k&TiwluK(Zt@|06=|r zPlL!HXltNjZ)N*Xf^vc~gEEG)hq8b&hx}VXSwrbV8A1V|7@_E)n4o}=fAB*Nf+c5b zrSG6;@Pzgb0t|p+fi$r}eyo2HHL 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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 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+ "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 0000000000000000000000000000000000000000..9c7b576ccd2b676eee60e79d5f94c73d7cf98956 GIT binary patch literal 24513 zcmce;1yo$i(mzUYNYLOqxH}AP!QI_uaCi4$!Gb#kf_n(=o)DY>f#3uP?rv{@oO{l_ 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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 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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 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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 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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 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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 0000000000000000000000000000000000000000..9ff6124094c6a783235fba38ac45832a7548e366 GIT binary patch literal 26108 zcmce-1yo$iwl<0dx8OlL!68UPL*woQcMtB+xCD0z5P<**?hqV;yE`GcTL{73?QbCa 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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 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"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 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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 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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 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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 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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 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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: 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OB4MmzVp;|m)_(x}aqp!7 literal 0 HcmV?d00001 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 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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 0000000000000000000000000000000000000000..9dd45a421c990daf00824fa050535f4e176599ad GIT binary patch literal 24486 zcmce-1yo$k(l&~O5Fo)_hXjJ#00RW~-~@Mfhr!(m7Tnz(g1cLQAi)U|oZt|gApZb) z&-zN^PaUn7&nA%$y z0x0k9sSp_i?F@D8t?eGppq!x0p-iCcp)8>+Aph1-Hc$poMo<7KMksnHCMY1}AM{Xy zaLL+P8#w42KCyj(5CfoCAWiI$AKPC-O|7kjbnPMi2)zR`0zr%*Mj#U_5Xi``Muo`3 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@@ +{ + "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 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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 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"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 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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 0000000000000000000000000000000000000000..127d8cc32353870ddd14d56d993994be9644ea67 GIT binary patch literal 25086 zcmce-1yo$k(l&}ExO=c6Xt049WN-}xcXt`w-6c3d5;V9Z!Civ81%ia&1Sd#v34x&h z0C~^*p7Wh`zyGeg)}2{guYl?%unfrc;uTWaVJvMB@Ok0~}1O(F6q0fNEB* zwom}$&FwQZptv*C*ww-L?g`EV&IZmB&K1rM&K7oefOCX1gENN%z_G)z!EwNWV0Z4j z7_5|%vxAwNDfFS3GK?4i#|g`Vz%HJ@m|8j5OBlPt>XG0Bv4gnTx!FM+Tp%tEUY%!X 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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 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--- /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 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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 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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 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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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040001_has_returned_a_medication_at_site_S10-CZ10004.pdf 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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 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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 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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 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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 0000000000000000000000000000000000000000..b5f8dbc160c390b0a584ab6cfd2580649f47ec6e GIT binary patch literal 25996 zcmce-1yo#3vo;EW1eZW?n;^l03=9nJPH+fLg1dWgw*bN2AxH@B?gWAc*Wm8%`~&3u z-uL^?`R_S*-L>w_+S9$etE#KJx~q5Zd5S_-NQ4eZ4?+Y27y*_#CWu^IhzyFxc4qnj zs=Iq?L~-~@*yJF@04NZoiVbps{}O6!X(6O-2Wdx$gNc!em64T^3CO|(W&*2GBl7Sd z>RaeN=)?R^y_~J|0Sv-UcA^S)5Kcq}1%7~?jr~JL3cyIu$b`tCs|^6sGeXqne@gkq z6#xd>X10$s+P0nzFbL^880+fGiwbD|r32evM2r9i z6;(9=Gcy2y$OdGlXJLH!004~tB4z*YNWm=s9Vw9Uzoi9&{u{Bte>2bHFz{PgSlU5) zZm(nac>m7W!W5A~USHP^p#GpBm=Op7Ffp+}a(|1|L}U=Kw9$hYM*X36h~5nRfJc)* z$<(!jSOp>!z@Q{Aj`;8cpfa+vv$Ex2U@+0Pu(j2uQ_P>sp#W+UoD| z1Ty{U)IWs&4~jB_!1Un9kpuvMU{-pjKY3;rcEJA^eQoWntSoKp{s(>kIln%9P?qGE z78H|_|G)%zFuFV(Twu{n6W^Xe+|LkD+x*hN*l@o$`#NNNK~9UvtS z^bd^&t8@Xz~~L`+sl&A7f2i zcWOic0J7L@^eyZFz=!20|4<;LZ)*qm=U_8ElnPqfL#P-ZveNoa5PH@}`hQHfhk_@! 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