z230

2026-06-01 16:50:50 +02:00
parent d017203644
commit 1eb7491177
1030 changed files with 2418 additions and 0 deletions
@@ -0,0 +1,10 @@
+{
+  "pk": 5296,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been screened at site S10-CZ10008",
+  "event": "Screen",
+  "actual_date": "2025-07-02",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Jul-2025 \n\nDate of Screening in IRT: 02-Jul-2025 \nTransaction Date/Time (site local): 02-Jul-2025  09:00:54\nTransaction Date/Time (system local): 02-Jul-2025  07:00:54\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": 6330,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 randomized into Part 1 at site S10-CZ10008",
+  "event": "Rand",
+  "actual_date": "2025-07-30",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1174325Seltorexant 20mg or placeboT38028505-Apr-20261175967Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 30-Jul-2025  12:07:13\nTransaction Date/Time (system local): 30-Jul-2025  10:07:13\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": 6488,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been screened at site S10-CZ10011",
+  "event": "Screen",
+  "actual_date": "2025-08-03",
+  "subject": "CZ100110001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110001  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Aug-2025 \n\nDate of Screening in IRT: 03-Aug-2025 \nTransaction Date/Time (site local): 03-Aug-2025  09:20:50\nTransaction Date/Time (system local): 03-Aug-2025  07:20:50\n\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 6611,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080003 has been screened at site S10-CZ10008",
+  "event": "Screen",
+  "actual_date": "2025-08-06",
+  "subject": "CZ100080003",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080003  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080003 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 05-Aug-2025 \n\nDate of Screening in IRT: 06-Aug-2025 \nTransaction Date/Time (site local): 06-Aug-2025  10:05:11\nTransaction Date/Time (system local): 06-Aug-2025  08:05:11\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": 6610,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been screened at site S10-CZ10011",
+  "event": "Screen",
+  "actual_date": "2025-08-06",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 06-Aug-2025 \n\nDate of Screening in IRT: 06-Aug-2025 \nTransaction Date/Time (site local): 06-Aug-2025  08:11:02\nTransaction Date/Time (system local): 06-Aug-2025  06:11:02\n\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 6621,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100120001 has been screened at site S10-CZ10012",
+  "event": "Screen",
+  "actual_date": "2025-08-06",
+  "subject": "CZ100120001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100120001  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 06-Aug-2025 \n\nDate of Screening in IRT: 06-Aug-2025 \nTransaction Date/Time (site local): 06-Aug-2025  13:38:55\nTransaction Date/Time (system local): 06-Aug-2025  11:38:55\n\nTransaction performed by: yooma.kadlec@gmail.com\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 6953,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1174325\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 30-Jul-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1175967\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 30-Jul-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025  12:15:42\n\nTransaction Date/Time (system local): 13-Aug-2025  10:15:42 \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": 6955,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1010861\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 13-Aug-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1164714\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 13-Aug-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025  12:27:39\n\nTransaction Date/Time (system local): 13-Aug-2025  10:27:39 \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": 8127,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1204917\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 10-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1237507\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 10-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 10-Sep-2025  11:42:48\n\nTransaction Date/Time (system local): 10-Sep-2025  09:42:48 \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": 8256,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1244191\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 12-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1272627\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 12-Sep-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 12-Sep-2025  09:52:11\n\nTransaction Date/Time (system local): 12-Sep-2025  07:52:11 \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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 6954,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10008",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1010861Seltorexant 20mg or placeboT38028505-Apr-20261164714Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025  12:25:18 \nTransaction Date/Time (system local): 13-Aug-2025  10:25:18 \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": 6956,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008",
+  "event": "uv_return",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100080001  has been performed.\nMedication ID: 1174325\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1175967\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: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025  12:51:00 \nTransaction Date/Time (system local): 13-Aug-2025  10:51:00 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 12034,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008",
+  "event": "uv_return",
+  "actual_date": "2025-08-13",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100080001  has been performed.\nMedication ID: 1045106\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1094105\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: CZ100080001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025  08:26:14 \nTransaction Date/Time (system local): 25-Nov-2025  07:26:14 \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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 7378,
+  "title": "Screenfail",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080003 has been screen failed at site S10-CZ10008",
+  "event": "uv_screen_fail",
+  "actual_date": "2025-08-25",
+  "subject": "CZ100080003",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080003 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 25-Aug-2025\nTransaction Date/Time (site local): 25-Aug-2025  15:19:47\nTransaction Date/Time (system local): 25-Aug-2025  13:19:47\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": 7503,
+  "title": "No_Rollover_Part_2",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 Completed Part 1 will not rollover into Part 2 at site S10-CZ10008",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has completed part 1 and will not roll over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 27-Aug-2025  11:08:36\nTransaction Date/Time (system local): 27-Aug-2025  09:08:36\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": 7505,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1045106\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 27-Aug-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1094105\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n    Dispensed\nDispensation date: 27-Aug-2025\nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 27-Aug-2025  11:09:23\n\nTransaction Date/Time (system local): 27-Aug-2025  09:09:23 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9024,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1251872\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Not Dispensed\nDispensation date: \nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1294645\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Not Dispensed\nDispensation date: \nNote (only collected if Not Dispensed):\n     \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Sep-2025  11:52:55\n\nTransaction Date/Time (system local): 29-Sep-2025  09:52:55 \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": 7504,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10008",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1045106Seltorexant 20mg or placeboT38028505-Apr-20261094105Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 27-Aug-2025  11:08:36 \nTransaction Date/Time (system local): 27-Aug-2025  09:08:36 \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": 7500,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008",
+  "event": "uv_return",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100080001  has been performed.\nMedication ID: 1010861\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1164714\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: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 27-Aug-2025  10:48:18 \nTransaction Date/Time (system local): 27-Aug-2025  08:48:18 \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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 12035,
+  "title": "Medication_Return",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008",
+  "event": "uv_return",
+  "actual_date": "2025-08-27",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject  CZ100080001  has been performed.\nMedication ID: 1204917\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1237507\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: CZ100080001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025  08:31:27 \nTransaction Date/Time (system local): 25-Nov-2025  07:31:27 \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"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 7589,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110001 randomized into Part 1 at site S10-CZ10011",
+  "event": "Rand",
+  "actual_date": "2025-08-28",
+  "subject": "CZ100110001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110001  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1150031Seltorexant 20mg or placeboT38028505-Apr-20261194071Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 28-Aug-2025  09:34:17\nTransaction Date/Time (system local): 28-Aug-2025  07:34:17\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": 7595,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 randomized into Part 1 at site S10-CZ10011",
+  "event": "Rand",
+  "actual_date": "2025-08-28",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1040913Seltorexant 20mg or placeboT38028505-Apr-20261060564Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 28-Aug-2025  11:24:07\nTransaction Date/Time (system local): 28-Aug-2025  09:24:07\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": 7594,
+  "title": "Screenfail",
+  "label": "Janssen 42847922MDD3003 Subject CZ100120001 has been screen failed at site S10-CZ10012",
+  "event": "uv_screen_fail",
+  "actual_date": "2025-08-28",
+  "subject": "CZ100120001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120001 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 28-Aug-2025\nTransaction Date/Time (site local): 28-Aug-2025  10:59:13\nTransaction Date/Time (system local): 28-Aug-2025  08:59:13\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 8053,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100050001 has been screened at site S10-CZ10005",
+  "event": "Screen",
+  "actual_date": "2025-09-09",
+  "subject": "CZ100050001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100050001  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10005 \nInvestigator: Janů, Luboš \n\n \nSubject Details \nSubject: CZ100050001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 09-Sep-2025 \n\nDate of Screening in IRT: 09-Sep-2025 \nTransaction Date/Time (site local): 09-Sep-2025  10:47:27\nTransaction Date/Time (system local): 09-Sep-2025  08:47:27\n\nTransaction performed by: spinkova@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": 8126,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10008",
+  "event": "OL_Ind_V1_1",
+  "actual_date": "2025-09-10",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1204917Seltorexant 20mgT37484802-May-20261237507Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 10-Sep-2025  11:41:55 \nTransaction Date/Time (system local): 10-Sep-2025  09:41:55 \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": 8123,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-09-10",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1007696Seltorexant 20mg or placeboT38028505-Apr-20261123387Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 10-Sep-2025  10:03:19 \nTransaction Date/Time (system local): 10-Sep-2025  08:03:19 \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": 8194,
+  "title": "Medication_replacement",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has replaced a medication at site S10-CZ10008",
+  "event": "uv_replace",
+  "actual_date": "2025-09-11",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nMedication(s) have/has been replaced for Subject  CZ100080001. \n\nThe replaced medication ID:  1204917\n 1237507\n\nPlease assign the following medication(s) to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1244191Seltorexant 20mgT37484802-May-20261272627Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 11-Sep-2025  14:58:12 \nTransaction Date/Time (system local): 11-Sep-2025  12:58:12 \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": 8193,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011",
+  "event": "DB_P1_V6",
+  "actual_date": "2025-09-11",
+  "subject": "CZ100110001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1092399Seltorexant 20mg or placeboT38028505-Apr-20261141877Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 11-Sep-2025  14:05:40 \nTransaction Date/Time (system local): 11-Sep-2025  12:05:40 \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": 8626,
+  "title": "Screening",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been screened at site S10-CZ10004",
+  "event": "Screen",
+  "actual_date": "2025-09-19",
+  "subject": "CZ100040002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040002  has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 19-Sep-2025 \n\nDate of Screening in IRT: 19-Sep-2025 \nTransaction Date/Time (site local): 19-Sep-2025  08:45:25\nTransaction Date/Time (system local): 19-Sep-2025  06:45:25\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": 8652,
+  "title": "Screenfail",
+  "label": "Janssen 42847922MDD3003 Subject CZ100050001 has been screen failed at site S10-CZ10005",
+  "event": "uv_screen_fail",
+  "actual_date": "2025-09-19",
+  "subject": "CZ100050001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10005 \nInvestigator: Janů, Luboš \n\n \nSubject Details \nSubject: CZ100050001 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 19-Sep-2025\nTransaction Date/Time (site local): 19-Sep-2025  15:53:24\nTransaction Date/Time (system local): 19-Sep-2025  13:53:24\nTransaction performed by: spinkova@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": 8843,
+  "title": "Rollover_Part_2",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 Rolled Over from Part 1 into Part 2 at site S10-CZ10011",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-09-24",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 24-Sep-2025  14:01:14\nTransaction Date/Time (system local): 24-Sep-2025  12:01:14\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": 8844,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10011",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-09-24",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1095351Seltorexant 20mg or placeboT38028505-Apr-20261109959Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 24-Sep-2025  14:01:13 \nTransaction Date/Time (system local): 24-Sep-2025  12:01:13 \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": 8954,
+  "title": "Rollover_Part_2",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110001 Rolled Over from Part 1 into Part 2 at site S10-CZ10011",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-09-26",
+  "subject": "CZ100110001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110001  has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Sep-2025  11:28:23\nTransaction Date/Time (system local): 26-Sep-2025  09:28:23\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": 8955,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10011",
+  "event": "DB_P1_V7",
+  "actual_date": "2025-09-26",
+  "subject": "CZ100110001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110001  has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1050820Seltorexant 20mg or placeboT38028505-Apr-20261156231Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Sep-2025  11:28:23 \nTransaction Date/Time (system local): 26-Sep-2025  09:28:23 \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": 9023,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10008",
+  "event": "OL_Ind_V1_4",
+  "actual_date": "2025-09-29",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100080001  has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1251872Seltorexant 20mgT37484802-May-20261294645Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Sep-2025  11:49:43 \nTransaction Date/Time (system local): 29-Sep-2025  09:49:43 \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": 9514,
+  "title": "Dispensation",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008",
+  "event": "uv_disp_conf",
+  "actual_date": "2025-10-08",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject  CZ100080001  has\nbeen performed for the following medication IDs:\n\nMedication No: 1270859\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n    Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n     \n\nMedication No: 1284666\n\nProduct Label Type: Seltorexant 20mg\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:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 08-Oct-2025  13:02:10\n\nTransaction Date/Time (system local): 08-Oct-2025  11:02:10 \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": 9512,
+  "title": "Assignment_MADRS",
+  "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10008",
+  "event": "OL_Ind_V1_5",
+  "actual_date": "2025-10-08",
+  "subject": "CZ100080001",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject  CZ100080001  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    1270859\r\n    Seltorexant 20mg\r\n    T374848\r\n    02-May-2026\r\n1284666\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: CZ100080001 \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): 08-Oct-2025  12:37:51 \n\r\n    Transaction Date/Time (system local): 08-Oct-2025  10:37:51 \n\r\n    Transaction performed by: m.deif@clintrial.cz\n \n\r\n    If you have questions about this notification, please contact 4G Clinical Support at \n\r\n    https://support.4gclinical.com"
+}
@@ -0,0 +1,10 @@
+{
+  "pk": 9566,
+  "title": "Assignment",
+  "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10011",
+  "event": "OL_Ind_V1_1",
+  "actual_date": "2025-10-09",
+  "subject": "CZ100110002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100110002  has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1236395Seltorexant 20mgT37484802-May-20261260207Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 09-Oct-2025  08:29:29 \nTransaction Date/Time (system local): 09-Oct-2025  06:29:29 \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": 9972,
+  "title": "Randomized_Part_1",
+  "label": "Janssen 42847922MDD3003 Subject CZ100040002 randomized into Part 1 at site S10-CZ10004",
+  "event": "Rand",
+  "actual_date": "2025-10-17",
+  "subject": "CZ100040002",
+  "study": "42847922MDD3003",
+  "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject  CZ100040002  has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1078186Seltorexant 20mg or placeboT38028505-Apr-20261129823Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 17-Oct-2025  13:40:42\nTransaction Date/Time (system local): 17-Oct-2025  11:40:42\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com"
+}
--- a/Show More
+++ b/Show More