z230

2026-06-02 17:29:41 +02:00
parent b433ef0446
commit f11d407b73
453 changed files with 2150 additions and 0 deletions
@@ -0,0 +1,10 @@
+{
+  "pk": 6545,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been screened at site S10-CZ10008",
+  "event": "Screen",
+  "actual_date": "2025-08-05",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 04-Aug-2025 \n\nDate of Screening in IRT: 05-Aug-2025 \nTransaction Date/Time (site local): 05-Aug-2025  09:24:09\nTransaction Date/Time (system local): 05-Aug-2025  07:24:09\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8785,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-26",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080002  has\nbeen performed for the following medication IDs:\n\nMedication No: 1003030\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 23-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1186247\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 23-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 23-Sep-2025  11:17:14\n\nTransaction Date/Time (system local): 23-Sep-2025  09:17:14 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 7426,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 randomized into Part 1 at site S10-CZ10008",
+  "event": "Rand",
+  "actual_date": "2025-08-26",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1019782Seltorexant 20mg or placeboT38028505-Apr-20261020699Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Aug-2025  13:03:37\nTransaction Date/Time (system local): 26-Aug-2025  11:03:37\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 7772,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100120002 has been screened at site S10-CZ10012",
+  "event": "Screen",
+  "actual_date": "2025-09-03",
+  "subject": "CZ100120002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100120002  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Sep-2025 \n\nDate of Screening in IRT: 03-Sep-2025 \nTransaction Date/Time (site local): 03-Sep-2025  13:44:09\nTransaction Date/Time (system local): 03-Sep-2025  11:44:09\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 7946,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 randomized into Part 1 at site S10-CZ10004",
+  "event": "Rand",
+  "actual_date": "2025-09-05",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040001  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1109895Seltorexant 20mg or placeboT38028505-Apr-20261125335Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 05-Sep-2025  10:23:26\nTransaction Date/Time (system local): 05-Sep-2025  08:23:26\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8056,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-09-09",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080002  has\nbeen performed for the following medication IDs:\n\nMedication No: 1043808\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 09-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1056387\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 09-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 09-Sep-2025  12:10:27\n\nTransaction Date/Time (system local): 09-Sep-2025  10:10:27 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9416,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-09-09",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080002  has\nbeen performed for the following medication IDs:\n\nMedication No: 1206881\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 07-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1299156\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 07-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 07-Oct-2025  12:04:04\n\nTransaction Date/Time (system local): 07-Oct-2025  10:04:04 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8055,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-09-09",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1043808Seltorexant 20mg or placeboT38028505-Apr-20261056387Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 09-Sep-2025  12:09:34 \nTransaction Date/Time (system local): 09-Sep-2025  10:09:34 \nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8124,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been screened at site S10-CZ10008",
+  "event": "Screen",
+  "actual_date": "2025-09-10",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080005  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 09-Sep-2025 \n\nDate of Screening in IRT: 10-Sep-2025 \nTransaction Date/Time (site local): 10-Sep-2025  10:44:50\nTransaction Date/Time (system local): 10-Sep-2025  08:44:50\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8351,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080004 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-09-16",
+  "subject": "CZ100080004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080004  has\nbeen performed for the following medication IDs:\n\nMedication No: 1076269\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 16-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1094935\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 16-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 16-Sep-2025  12:54:42\n\nTransaction Date/Time (system local): 16-Sep-2025  10:54:42 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8350,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080004 randomized into Part 1 at site S10-CZ10008",
+  "event": "Rand",
+  "actual_date": "2025-09-16",
+  "subject": "CZ100080004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080004  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1076269Seltorexant 20mg or placeboT38028505-Apr-20261094935Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 16-Sep-2025  12:53:29\nTransaction Date/Time (system local): 16-Sep-2025  10:53:29\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8335,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080006 has been screened at site S10-CZ10008",
+  "event": "Screen",
+  "actual_date": "2025-09-16",
+  "subject": "CZ100080006",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080006  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080006 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 15-Sep-2025 \n\nDate of Screening in IRT: 16-Sep-2025 \nTransaction Date/Time (site local): 16-Sep-2025  09:14:53\nTransaction Date/Time (system local): 16-Sep-2025  07:14:53\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8636,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10004",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-09-19",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1077721Seltorexant 20mg or placeboT38028505-Apr-20261173637Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 19-Sep-2025  11:44:36 \nTransaction Date/Time (system local): 19-Sep-2025  09:44:36 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9348,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-09-22",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100040001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1033211\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 03-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1183601\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 03-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 06-Oct-2025  08:58:27\n\nTransaction Date/Time (system local): 06-Oct-2025  06:58:27 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8682,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004",
+  "event": "uv_return",
+  "actual_date": "2025-09-22",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100040001  has been performed.\nMedication ID: 1109895\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1125335\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Sep-2025  09:51:59 \nTransaction Date/Time (system local): 22-Sep-2025  07:51:59 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9349,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004",
+  "event": "uv_return",
+  "actual_date": "2025-09-22",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100040001  has been performed.\nMedication ID: 1077721\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1173637\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 06-Oct-2025  08:59:42 \nTransaction Date/Time (system local): 06-Oct-2025  06:59:42 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8783,
+  "title": "Rollover_Part_2",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 Rolled Over from Part 1 into Part 2 at site S10-CZ10008",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-09-23",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 23-Sep-2025  11:15:47\nTransaction Date/Time (system local): 23-Sep-2025  09:15:47\n\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9146,
+  "title": "Screenfail",
+  "label": "Janssen 42847922MDD3003 Subject CZ100120002 has been screen failed at site S10-CZ10012",
+  "event": "uv_screen_fail",
+  "actual_date": "2025-09-29",
+  "subject": "CZ100120002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120002 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 29-Sep-2025\nTransaction Date/Time (site local): 01-Oct-2025  12:24:16\nTransaction Date/Time (system local): 01-Oct-2025  10:24:16\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9092,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080004 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-09-30",
+  "subject": "CZ100080004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080004  has\nbeen performed for the following medication IDs:\n\nMedication No: 1113623\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 30-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1192373\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 30-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080004 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 30-Sep-2025  11:23:38\n\nTransaction Date/Time (system local): 30-Sep-2025  09:23:38 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9144,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100120003 has been screened at site S10-CZ10012",
+  "event": "Screen",
+  "actual_date": "2025-10-01",
+  "subject": "CZ100120003",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100120003  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120003 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Oct-2025 \n\nDate of Screening in IRT: 01-Oct-2025 \nTransaction Date/Time (site local): 01-Oct-2025  12:11:44\nTransaction Date/Time (system local): 01-Oct-2025  10:11:44\n\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9285,
+  "title": "Rollover_Part_2",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 Rolled Over from Part 1 into Part 2 at site S10-CZ10004",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-10-03",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040001  has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 03-Oct-2025  13:17:58\nTransaction Date/Time (system local): 03-Oct-2025  11:17:58\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9286,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10004",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-10-03",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1033211Seltorexant 20mg or placeboT38028505-Apr-20261183601Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 03-Oct-2025  13:17:57 \nTransaction Date/Time (system local): 03-Oct-2025  11:17:57 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9272,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110004 has been screened at site S10-CZ10011",
+  "event": "Screen",
+  "actual_date": "2025-10-03",
+  "subject": "CZ100110004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110004  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110004 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Oct-2025 \n\nDate of Screening in IRT: 03-Oct-2025 \nTransaction Date/Time (site local): 03-Oct-2025  09:57:26\nTransaction Date/Time (system local): 03-Oct-2025  07:57:26\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9415,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10008",
+  "event": "OL_Ind_V1_1",
+  "actual_date": "2025-10-07",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1206881Seltorexant 20mgT37484802-May-20261299156Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 07-Oct-2025  12:02:51 \nTransaction Date/Time (system local): 07-Oct-2025  10:02:51 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9513,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-08",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080005  has\nbeen performed for the following medication IDs:\n\nMedication No: 1123910\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1148249\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 08-Oct-2025  13:01:35\n\nTransaction Date/Time (system local): 08-Oct-2025  11:01:35 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 11269,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-08",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080005  has\nbeen performed for the following medication IDs:\n\nMedication No: 1039446\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 12-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1051859\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 12-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 12-Nov-2025  11:19:30\n\nTransaction Date/Time (system local): 12-Nov-2025  10:19:30 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9511,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 randomized into Part 1 at site S10-CZ10008",
+  "event": "Rand",
+  "actual_date": "2025-10-08",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080005  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1123910Seltorexant 20mg or placeboT38028505-Apr-20261148249Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 08-Oct-2025  11:41:30\nTransaction Date/Time (system local): 08-Oct-2025  09:41:30\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9821,
+  "title": "Discontinue",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080004 has been discontinued from IRT managed treatment at site S10-CZ10008",
+  "event": "uv_discontinue",
+  "actual_date": "2025-10-14",
+  "subject": "CZ100080004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject  CZ100080004  has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080004 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 14-Oct-2025 \nTransaction Date/Time (site local): 15-Oct-2025  14:56:51\nTransaction Date/Time (system local): 15-Oct-2025  12:56:51\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9967,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10004",
+  "event": "OL_Ind_V1_1",
+  "actual_date": "2025-10-17",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040001  has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1284494Seltorexant 20mgT37484802-May-20261297594Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Oct-2025  12:00:57 \nTransaction Date/Time (system local): 17-Oct-2025  10:00:57 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10680,
+  "title": "Screenfail",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110004 has been screen failed at site S10-CZ10011",
+  "event": "uv_screen_fail",
+  "actual_date": "2025-10-17",
+  "subject": "CZ100110004",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110004 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 17-Oct-2025\nTransaction Date/Time (site local): 31-Oct-2025  08:27:45\nTransaction Date/Time (system local): 31-Oct-2025  07:27:45\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10013,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-20",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100040001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1284494\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1297594\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Oct-2025  08:35:08\n\nTransaction Date/Time (system local): 20-Oct-2025  06:35:08 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10012,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004",
+  "event": "uv_return",
+  "actual_date": "2025-10-20",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100040001  has been performed.\nMedication ID: 1033211\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1183601\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 20-Oct-2025  08:33:59 \nTransaction Date/Time (system local): 20-Oct-2025  06:33:59 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10103,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10008",
+  "event": "OL_Ind_V1_4",
+  "actual_date": "2025-10-21",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080002  has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1263293Seltorexant 20mgT37484802-May-20261284662Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 21-Oct-2025  11:10:07 \nTransaction Date/Time (system local): 21-Oct-2025  09:10:07 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10195,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-22",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080005  has\nbeen performed for the following medication IDs:\n\nMedication No: 1017229\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1018200\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Oct-2025  10:53:58\n\nTransaction Date/Time (system local): 22-Oct-2025  08:53:58 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 11621,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-22",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080005  has\nbeen performed for the following medication IDs:\n\nMedication No: 1223095\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1241228\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 18-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080005 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 18-Nov-2025  11:20:59\n\nTransaction Date/Time (system local): 18-Nov-2025  10:20:59 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10194,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080005 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-10-22",
+  "subject": "CZ100080005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080005  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1017229Seltorexant 20mg or placeboT38028505-Apr-20261018200Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080005 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Oct-2025  10:52:42 \nTransaction Date/Time (system local): 22-Oct-2025  08:52:42 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10363,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080002 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-24",
+  "subject": "CZ100080002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080002  has\nbeen performed for the following medication IDs:\n\nMedication No: 1263293\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 21-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1284662\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 21-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Oct-2025  14:49:04\n\nTransaction Date/Time (system local): 24-Oct-2025  12:49:04 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 12065,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080006 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-29",
+  "subject": "CZ100080006",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080006  has\nbeen performed for the following medication IDs:\n\nMedication No: 1097147\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1115018\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 25-Nov-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 25-Nov-2025  09:41:01\n\nTransaction Date/Time (system local): 25-Nov-2025  08:41:01 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10529,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080006 randomized into Part 1 at site S10-CZ10008",
+  "event": "Rand",
+  "actual_date": "2025-10-29",
+  "subject": "CZ100080006",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080006  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1032775Seltorexant 20mg or placeboT38028505-Apr-20261038889Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080006 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 29-Oct-2025  10:20:55\nTransaction Date/Time (system local): 29-Oct-2025  09:20:55\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10740,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 dispensing confirmation has occurred at site S10-CZ10004",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-11-03",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100040001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1222097\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 31-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1267690\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 31-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Nov-2025  08:56:53\n\nTransaction Date/Time (system local): 03-Nov-2025  07:56:53 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10739,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040001 has returned a medication at site S10-CZ10004",
+  "event": "uv_return",
+  "actual_date": "2025-11-03",
+  "subject": "CZ100040001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100040001  has been performed.\nMedication ID: 1284494\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1297594\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 03-Nov-2025  08:56:15 \nTransaction Date/Time (system local): 03-Nov-2025  07:56:15 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 10748,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110005 has been screened at site S10-CZ10011",
+  "event": "Screen",
+  "actual_date": "2025-11-03",
+  "subject": "CZ100110005",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110005  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110005 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 03-Nov-2025 \n\nDate of Screening in IRT: 03-Nov-2025 \nTransaction Date/Time (site local): 03-Nov-2025  09:39:17\nTransaction Date/Time (system local): 03-Nov-2025  08:39:17\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
--- a/Show More
+++ b/Show More