From 1eb7491177089f15548e8fe3344dcdd1f732d3e2 Mon Sep 17 00:00:00 2001 From: "vladimir.buzalka" Date: Mon, 1 Jun 2026 16:50:50 +0200 Subject: [PATCH] z230 --- IWRS/Patients/CONTEXT.md | 56 +++++ ...2847922MDD3003 Subject Summary Report.xlsx | Bin 0 -> 10209 bytes ...13UCO3001 Subject Summary Report 1630.xlsx | Bin 0 -> 8007 bytes ...13UCO3001 Subject Summary Report 1632.xlsx | Bin 0 -> 8007 bytes ...7242113UCO3001 Subject Summary Report.xlsx | Bin 0 -> 8007 bytes ...922MDD3003 CZ100040001 Subject Detail.xlsx | Bin 0 -> 9352 bytes ...922MDD3003 CZ100040002 Subject Detail.xlsx | Bin 0 -> 9219 bytes ...922MDD3003 CZ100040004 Subject Detail.xlsx | Bin 0 -> 8788 bytes ...922MDD3003 CZ100040007 Subject Detail.xlsx | Bin 0 -> 7908 bytes ...922MDD3003 CZ100050001 Subject Detail.xlsx | Bin 0 -> 5593 bytes ...922MDD3003 CZ100050002 Subject Detail.xlsx | Bin 0 -> 5594 bytes ...922MDD3003 CZ100080001 Subject Detail.xlsx | Bin 0 -> 6977 bytes ...922MDD3003 CZ100080003 Subject Detail.xlsx | Bin 0 -> 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jednoho pacienta (CZ100222003 / UCO3001) +- `create_iwrs_tables.py` — jednorázový skript pro vytvoření MySQL tabulek + +### Upravené soubory +- `download_subject_details.py` — přidáno stahování notifikací (PDF + JSON) pro každý subjekt přímo v loopě +- `import_to_mysql.py` — přidána funkce `import_notifications()` která importuje JSON+PDF do DB a přesouvá do `Zpracováno/` +- `create_iwrs_tables.sql` — přidána tabulka `iwrs_notifications` +- `run_all.py` — krok 2 nyní volá `dsd.run()` z `download_subject_details.py` + +## Jak to funguje + +### Stahování notifikací (v `download_subject_details.py`) +1. Při výběru subjektu se zachytí `table_1` API response (obsahuje notifikace s `pk`, `et_title`, `label`, `body`, `actual_date_raw`) +2. Porovná `pk` s DB (`iwrs_notifications`) — stahuje jen nové +3. Stáhne PDF přes `page.request.get()` s Bearer tokenem (JWT se načítá čerstvě před každým requestem) +4. Uloží PDF + JSON do `IncomingSourceReportsDetails/{study}/` +5. Název souboru: `{actual_date_raw}_{label_s_podtržítky}.pdf` (při kolizi přidá `_pk{pk}`) + +### API endpointy +- **Notifikace data**: `POST /_/p/{instance_id}/api/v1/reports_api/report_data?path=patient_detail_report&id={subject}&key=table_1&unblinded=false` +- **PDF download**: `GET /_/p/{instance_id}/api/v1/meta_api/pdfnotification?pk={pk}&title={et_title}&html=true` +- **app_instances** (pro zjištění instance_id): `GET /_/api/dispatch/app_instances/` +- Headers: `Authorization: Bearer {JWT}`, `lang: en`, `prancer_study: {study_code}` + +### Instance ID mapping +- `77242113UCO3001` → `/_/p/106` +- `42847922MDD3003` → `/_/p/70` +- `77242113CRD3001` → `/_/p/103` + +### Import (`import_to_mysql.py`) +- Čte všechny `.json` soubory z `IncomingSourceReportsDetails/{study}/` +- Načte příslušné `.pdf` jako binární data +- Uloží do tabulky `iwrs_notifications` (UNIQUE KEY na `pk` — bez duplikátů) +- Přesune soubory do `IncomingSourceReportsDetails/{study}/Zpracováno/` + +## MySQL tabulka `iwrs_notifications` +```sql +id, study, subject, pk (UNIQUE), title, label, event, actual_date, text (TEXT), pdf (MEDIUMBLOB), source_file, imported_at +``` + +## Aktuální stav +- UCO3001: ~76 notifikací importováno +- MDD3003: ~119 notifikací importováno (část 403 chyb — JWT expiroval, opraveno načítáním JWT čerstvě) +- MDD3003 notifikace s 403 čekají na příští `run_all.py` (soubory nejsou v `Zpracováno`, takže se znovu stáhnou) + +## Co zbývá / možná vylepšení +- Ověřit že MDD3003 403 chyby jsou opraveny (JWT refresh) +- `CZ100132003` UCO3001 — timeout při stahování XLS (subjekt přeskočen, zkusit znovu) +- Případně přidat retry logiku pro timeout diff --git a/IWRS/Patients/IncomingSourceReports/2026-06-01 42847922MDD3003 Subject Summary Report.xlsx b/IWRS/Patients/IncomingSourceReports/2026-06-01 42847922MDD3003 Subject Summary Report.xlsx new file mode 100644 index 0000000000000000000000000000000000000000..c622836589b616a9e9f41b593a3dd981ae29a513 GIT binary patch literal 10209 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-30_Janssen_42847922MDD3003_Subject_CZ100080001_randomized_into_Part_1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..bcc602e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-30_Janssen_42847922MDD3003_Subject_CZ100080001_randomized_into_Part_1_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-30_Janssen_42847922MDD3003_Subject_CZ100080001_randomized_into_Part_1_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-30_Janssen_42847922MDD3003_Subject_CZ100080001_randomized_into_Part_1_at_site_S10-CZ10008.pdf new file mode 100644 index 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 0000000..0aece5e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000000000000000000000000000000000000..c47e61462967c5d26a3c73cd9f3d9e0fc800c082 GIT binary patch literal 23885 zcmce-1yr2N(l$zP3lJcF4-nE^n6m7XawFE28al8L=J7(jjh zK!eOAYzx-4x3YaKK{-L0K^a5YLs>wXL%yw`tf35`450u}Kqy8iW+)KkoBc5d=_O}t zW#FI>{@qO;LJWXng*0(OJ{*5BHL=g4luVKxSrERv?H~od%ho9~o?E z@F)+}?$$GtvMcBM^klq^}ELW&}dS7W$nEi7NsO zb0z8@gH&1eF*0BU1?|03@{*Vl&+s**x7!tZ1i zK7as^Mpr;)`bQlr;L*DOUdIl2GNZyjRxC5yzf|zICqYR-=|WjT*+Jf5Nc!jwAc#A# 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file mode 100644 index 0000000..9969eeb --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk6955.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk6955.json new file mode 100644 index 0000000..87f17a2 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk6955.json @@ -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 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.json new file mode 100644 index 0000000..0fc0134 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.json @@ -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" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..6cb495c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10008.json @@ -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 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json @@ -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: 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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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.pdf new file mode 100644 index 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10008.json new file mode 100644 index 0000000..4109df7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_Completed_Part_1_will_not_rollover_into_Part_2_at_site_S10-CZ10008.pdf 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100644 index 0000000..531cfb1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf 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"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: 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"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 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"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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json new file mode 100644 index 0000000..66f19e4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.json new file mode 100644 index 0000000..97fa4e4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.pdf new file mode 100644 index 0000000000000000000000000000000000000000..f5a569581b9bd4c1939f3061a0a6599578f36549 GIT binary patch literal 23825 zcmce-1yr2N(l&~Fa0@zt;6Vm=cXyZI?(XgoAb4;O?(R;|-~@sPCs=R^{{Y!%?{mJh z?)Tqy*Sa%n-nOdh>aOnUdRIR~CNC^X3#4O400I~Qwgwgm+}sHC%H~d1#sJFSk5mZs zLJr3IPPPtDB`{YoOE5DqCopR;E6~#x%nr;5%mfSo#sEeK1_WaSJz1Y}ATD_aTO(&f 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json @@ -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 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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" +} \ No newline at end of file diff --git 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+ "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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000000000000000000000000000000000000..cf2fc68b37d9f02b0e4abed8c237dcb6df846220 GIT binary patch literal 24874 zcmce-1yo$i(m#p?4G=u|1Pu;@ySux)ySoSXpur)y22ThQTm!+~o#5{B2FSVR-22`4 zzW-Zqtv9n~x_5VVb#+x&b?@E3O)4iOLc>7I1kV7V2iO`|z;kiI(pR&xJY9jgf?0x@fjNO$gIR(8ZNcoojKEC50ATcBv|tQiK+r$SQx4Qh&cW8m z+0gi_FH-jZM#{?k-$)tg|0^v6(|=*h@NedMRs+9{jja=C=>S?L)703eVVl>3{dHawkxt%DKBFq%)jgXE^;2Rxhng{Pqt z$SNSF06Jv_armb{zjwXIuTPPX^$h zLH&d2{~{=mjgc1ktVsZXftBT7c_910H1YpMY)5B1J6i{*|3&P7PBUFyRY`ssK`~hc 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json new file mode 100644 index 0000000..732a9a0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.json @@ -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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000000000000000000000000000000000000..1c8ddbdd68cbb5ee038a0cc0e2401e18bb8e6269 GIT binary patch literal 25991 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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" +} \ No newline at end of file diff --git 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"actual_date": "2025-10-20", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1039573\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1199588\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 14-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 18-Nov-2025 09:31:07\n\nTransaction Date/Time (system local): 18-Nov-2025 08:31:07 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.pdf new file mode 100644 index 0000000000000000000000000000000000000000..f769f6fff553bc61dc471425b45c89b13c6931b0 GIT binary patch literal 24715 zcmce71yo$m(kBFh26rFaVVHpdg1fuBySr;h2tk7c*FbOx5C|SDXmCp)I0Oyux&!>} zz3=UQ-<~~ZXU@HC)z#HiUEO_e|1PbvxFjnF8z%|}00?k0wMF6QM`2gDaksYsFx=iT zqOgm(T9~*yx!$K>ykP8LtYO??9ANCBcPAKU7;_j)7yt|qh7E=T1_ZrB?qkqe%C1i4 z9%dGg)l{Iw02oea5fAj@{*$SVlcTtaJG33~=O7>m0)zlLI5@#P9NfB$D1w407LMlk 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..bc39a74 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10201, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-22", + "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: 1285194\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1297199\n\nProduct Label Type: Seltorexant 20mg\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:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 22-Oct-2025 11:51:08\n\nTransaction Date/Time (system local): 22-Oct-2025 09:51:08 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at 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zln2}_m;krLR8;YR1#Zey0S+28CEFB3WAH#HZ;sI&?$$gYZ81O9KwZce=4NUA?^Hlze$U)u(tBvrZ-2kODrh`d+Zsay_`W5E0pA~fim9Qt#?WZ& zPuB(-O#mNoo5urr0L1?t3-osajobV;{)>Rsnb1@8>r{Ee{4?7#Tl)BbCew^B1{)u6 WPX2)#moysmiNitQ@Iz+$kbeT`0P&*$ literal 0 HcmV?d00001 diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json new file mode 100644 index 0000000..27731c0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10200, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Open Label Induction Visit 1.6 at site S10-CZ10008", + "event": "OL_Ind_V1_6", + "actual_date": "2025-10-22", + "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 1.6:\r\n\n\r\n \r\n \r\n Medication No\r\n Medication Type\r\n Packaged Lot No\r\n Expiration Date\r\n 1285194\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1297199\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): 22-Oct-2025 11:49:46 \n\r\n Transaction Date/Time (system local): 22-Oct-2025 09:49:46 \n\r\n Transaction performed by: m.deif@clintrial.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000000000000000000000000000000000000..feb54b0e63c399e393169a364e1d2e72069bd974 GIT binary patch literal 26035 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.json new file mode 100644 index 0000000..29109d2 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11751, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been discontinued from IRT managed treatment at site S10-CZ10011", + "event": "uv_discontinue", + "actual_date": "2025-10-22", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100110001 has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 22-Oct-2025 \nTransaction Date/Time (site local): 19-Nov-2025 15:36:39\nTransaction Date/Time (system local): 19-Nov-2025 14:36:39\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000000000000000000000000000000000000..d4d56bbeaafdad5e4b21ef4750db76a2130614d3 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 10193, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10011", + "event": "OL_Ind_V1_4", + "actual_date": "2025-10-22", + "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 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1216273Seltorexant 20mgT37484802-May-20261258223Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json new file mode 100644 index 0000000..bbc197e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10699, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10004", + "event": "DB_P1_V6", + "actual_date": "2025-10-31", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Double Blind Part 1 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10745, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-11-03", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1012490\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 31-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1146893\n\nProduct Label Type: Seltorexant 20mg or placebo\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:\nCZ100040002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 03-Nov-2025 09:33:42\n\nTransaction Date/Time (system local): 03-Nov-2025 08:33:42 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..cbf25d8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 14736, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-01-12", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040002 has been performed.\nMedication ID: 1210651\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nMedication ID: 1235923\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 0\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 12-Jan-2026 20:14:37 \nTransaction Date/Time (system local): 12-Jan-2026 19:14:37 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf 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"2026-01-16", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100110002 has been Discontinued from IRT Managed Treatment.\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nDiscontinuation date: 16-Jan-2026 \nTransaction Date/Time (site local): 16-Jan-2026 10:23:58\nTransaction Date/Time (system local): 16-Jan-2026 09:23:58\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-05_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-05_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..f2c0cf8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-05_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16243, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10004", + "event": "OL_TS_V2_2", + "actual_date": "2026-02-05", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1212250Seltorexant 20mgT39247624-Jun-20281272090Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 05-Feb-2026 15:50:56 \nTransaction Date/Time (system local): 05-Feb-2026 14:50:56 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-02-09", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1212250\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1272090\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1229478\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1230246\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1260356\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1278762\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Jan-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1219546\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1246616\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 30-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 09-Feb-2026 09:19:42\n\nTransaction Date/Time (system local): 09-Feb-2026 08:19:42 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000000000000000000000000000000000000..725e1c607357151111f283c6e18ec81c5356ac9b GIT binary patch literal 27059 zcmc$_WmsIz(l&|)3lJ;>pCG~A-QC^Y-Q9x|+ycQpI0V<=1c%`6?(XCpAlc8e<$d>e z&X03uu9@!DU0q#W)vH(EtE-4)1cWGQsTg2s0W<(>Ju_Gi4p?dhQwIw}0LkMoQdnw! zJ40OuYrCf_5N8l`5EBpw5K9mX;J-D94Tu4V5eNW;280TP7K9G?&-9c7wvw^4HgME8 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returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-02-09", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040002 has been performed.\nMedication ID: 1229478\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1230246\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1260356\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1278762\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1219546\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1246616\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: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 09-Feb-2026 09:20:36 \nTransaction Date/Time (system local): 09-Feb-2026 08:20:36 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000000000000000000000000000000000000..fc517f0429079002c2f26d8a4a820b3c37735f46 GIT binary 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/dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-24_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 17317, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10004", + "event": "OL_TS_V2_3", + "actual_date": "2026-02-24", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1240119Seltorexant 20mgT39247624-Jun-20281270876Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Feb-2026 15:58:11 \nTransaction Date/Time (system local): 24-Feb-2026 14:58:11 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-24_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-24_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10004.pdf new file mode 100644 index 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"Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-03-02", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1240119\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 24-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1270876\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 24-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1212250\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1272090\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-Feb-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Mar-2026 08:32:01\n\nTransaction Date/Time (system local): 02-Mar-2026 07:32:01 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf 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0000000..172542c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 17594, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110011 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2026-03-02", + "subject": "CZ100110011", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110011 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110011 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 02-Mar-2026 \n\nDate of Screening in IRT: 02-Mar-2026 \nTransaction Date/Time (site local): 02-Mar-2026 08:59:30\nTransaction Date/Time (system local): 02-Mar-2026 07:59:30\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000000000000000000000000000000000000..235b6d0e6ee4c46b9ea10ceb66cf09c5bcd77993 GIT binary patch literal 23669 zcmce-1yr2P(m#lM@C1h;1oy$+-Q6L$yE_E;V8PuTLU0HWEO>DD;7)?u4v_c0@4ess z@3(vQoSiu{ZPnG)RbAEnO#g;dURactk&YRG5x@YjHLyV7=0>1bHg~cz22eaaQXMlc}goAoIN>Lu@BYvgQb z{L)PUL<|691~svRK5Tz6HMg}9)^`GpBg_e80J1W$GB7eSGqE#sXi_5Z@*)`97(L0u z^iR3m?Ti8RB5qD%N=~4j2=qz<04E3Mr;H4MfsO%)KyRoIV5DOJi7oJw3P>mcO!TcB 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17945, + "title": "Randomized_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 randomized into Part 2 at site S10-CZ10004", + "event": "DB_Main_V3_1", + "actual_date": "2026-03-06", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been randomized into Part 2.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1021590Seltorexant 20mg or placeboT38650424-Jun-20281082155Seltorexant 20mg or placeboT38650424-Jun-20281099967Seltorexant 20mg or placeboT38650424-Jun-20281111676Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-Mar-2026 11:02:33\nTransaction Date/Time (system local): 06-Mar-2026 10:02:33\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000000000000000000000000000000000000..5ac193cfd2612354f0fc7eff6b1b75121eda01d9 GIT binary patch literal 25094 zcmce-1yr2P(m#j>3liL!;I4xO3-0dj?iSqLEfAdG5+nq7m*7rt3lQ8L!VZx4zVE%? z-TnT1_MDwLGfzuZb#+&Fb@$W1CX*8qp<|*4!ZQIF0k#Gf@Z8++3`*usR>lCz-;Y%A z41x~E`cAeEPcbkTFiS8qFefl;Fe}i%Etnmc5ts=W0E`ig9*hZ$8T8Ng6asO{IoKLG z8ydf`$%BXiU_ek72k6KCmr!$C8zFrsP&q>Hm>HSb7}*$^n1C!CEUX$-@Vvb6#x_Pz 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+ "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040002 has been performed.\nMedication ID: 1240119\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 0\n\nMedication ID: 1270876\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 10\n\nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Mar-2026 11:32:06 \nTransaction Date/Time (system local): 09-Mar-2026 10:32:06 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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+ "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100110011 has been screen failed at site S10-CZ10011", + "event": "uv_screen_fail", + "actual_date": "2026-03-20", + "subject": "CZ100110011", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110011 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 20-Mar-2026\nTransaction Date/Time (site local): 22-Mar-2026 21:15:34\nTransaction Date/Time (system local): 22-Mar-2026 20:15:34\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 19098, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 randomized into Part 1 at site S10-CZ10004", + "event": "Rand", + "actual_date": "2026-03-25", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040007 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1033019Seltorexant 20mg or placeboT38650424-Jun-20281155666Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040007 \nIRT Subject Status: Randomized Part 1 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20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1155666\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 25-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 30-Mar-2026 10:12:45\n\nTransaction Date/Time (system local): 30-Mar-2026 08:12:45 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.json @@ -0,0 +1,10 @@ +{ + "pk": 22022, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-03-30", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1108216\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1070066\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 22-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1278232\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1242635\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 05-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 06-May-2026 08:34:22\n\nTransaction Date/Time (system local): 06-May-2026 06:34:22 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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HcmV?d00001 diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..caa9b0e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-07_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 19987, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Double Blind Maintenance Visit 3.2 at site S10-CZ10004", + "event": "DB_Main_V3_2", + "actual_date": "2026-04-07", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1035027Seltorexant 20mg or placeboT38650424-Jun-20281054757Seltorexant 20mg or placeboT38650424-Jun-20281061229Seltorexant 20mg or placeboT38650424-Jun-20281079547Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 07-Apr-2026 16:25:29 \nTransaction Date/Time (system local): 07-Apr-2026 14:25:29 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20362, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-04-13", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1079547\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1061229\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1054757\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1035027\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 07-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 13-Apr-2026 12:52:16\n\nTransaction Date/Time (system local): 13-Apr-2026 10:52:16 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..53a5033 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20351, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-04-13", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1171044\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1008773\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 09-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Apr-2026 12:02:34\n\nTransaction Date/Time (system local): 13-Apr-2026 10:02:34 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.json new file mode 100644 index 0000000..f6824b9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.json @@ -0,0 +1,10 @@ +{ + "pk": 23216, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-04-13", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040007 has\nbeen performed for the following medication IDs:\n\nMedication No: 1279864\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1215547\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 20-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-May-2026 09:09:17\n\nTransaction Date/Time (system local): 25-May-2026 07:09:17 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline 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"42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040007 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Apr-2026 13:21:24\nTransaction Date/Time (system local): 22-Apr-2026 11:21:24\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json new file mode 100644 index 0000000..00935ac --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 21072, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10004", + "event": "DB_P1_V7", + "actual_date": "2026-04-22", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040007 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1070066Seltorexant 20mg or placeboT38650424-Jun-20281108216Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040007 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 22-Apr-2026 13:21:24 \nTransaction Date/Time (system local): 22-Apr-2026 11:21:24 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 21491, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Double Blind Maintenance Visit 3.3 at site S10-CZ10004", + "event": "DB_Main_V3_3", + "actual_date": "2026-04-28", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1086477Seltorexant 20mg or placeboT38650424-Jun-20281095125Seltorexant 20mg or placeboT38650424-Jun-20281140830Seltorexant 20mg or placeboT38650424-Jun-20281171766Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 28-Apr-2026 12:34:02 \nTransaction Date/Time (system local): 28-Apr-2026 10:34:02 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.3_at_site_S10-CZ10004.pdf new file mode 100644 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..50d1cde --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 21940, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10004", + "event": "OL_Ind_V1_1", + "actual_date": "2026-05-05", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040007 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1242635Seltorexant 20mgT39247624-Jun-20281278232Seltorexant 20mgT39247624-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 05-May-2026 09:32:46 \nTransaction Date/Time (system local): 05-May-2026 07:32:46 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-05_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-25_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..121b88f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-25_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23217, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-05-25", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040007 has been performed.\nMedication ID: 1242635\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nMedication ID: 1278232\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: CZ100040007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 25-May-2026 09:10:05 \nTransaction Date/Time (system local): 25-May-2026 07:10:05 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-25_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-25_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-29_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23539, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Double Blind Maintenance Visit 3.4 at site S10-CZ10004", + "event": "DB_Main_V3_4", + "actual_date": "2026-05-29", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Double Blind Maintenance Visit 3.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1000100Seltorexant 20mg or placeboT38650424-Jun-20281033306Seltorexant 20mg or placeboT38650424-Jun-20281067500Seltorexant 20mg or placeboT38650424-Jun-20281094866Seltorexant 20mg or placeboT38650424-Jun-2028\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 29-May-2026 10:44:13 \nTransaction Date/Time (system local): 29-May-2026 08:44:13 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-29_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-29_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Maintenance_Visit_3.4_at_site_S10-CZ10004.pdf new file mode 100644 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..b30c344 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23649, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-06-01", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1094866\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1067500\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1033306\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-May-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1000100\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 29-May-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 01-Jun-2026 11:21:22\n\nTransaction Date/Time (system local): 01-Jun-2026 09:21:22 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000000000000000000000000000000000000..78e5c759dc9be25b144cf6e3276e96cacf23c686 GIT binary patch literal 25114 zcmce-1z26X);78*?pCDe!ln3P;SMcUytsRDcXxLy?(R_BiWf?uP~4?J3l!I4{{r?t zd+&43f4}cO_jxXhIb$OuBN-XVO!9_GUhFj^D-$~sE06_fV_=TN$A`rH*38k;7)X0} zPlv=TYHzIXXk-5n0=NJy0Pg^f04sncfC<0~V1v9l9(<5o^7b}H zPKL%$*%TneKma==i3{>@{>jwL##&6@5mJsA4;u>`2MY%aD=RyQiyfpvha@0?WNdBp 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..561f02a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 23650, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-06-01", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040002 has been performed.\nMedication ID: 1086477\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nMedication ID: 1095125\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1140830\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1171766\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: CZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 01-Jun-2026 11:22:32 \nTransaction Date/Time (system local): 01-Jun-2026 09:22:32 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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"label": "Janssen 77242113UCO3001 Subject CZ100222001 has been created in IRT at site DD5-CZ10022", + "event": "Create", + "actual_date": "2026-01-15", + "subject": "CZ100222001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 15-Jan-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 15-Jan-2026\n\nTransaction Date/Time (site local): 15-Jan-2026 16:07:14\n\nTransaction Date/Time (system local): 15-Jan-2026 15:07:14\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about 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Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 23-Jan-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 23-Jan-2026\n\nTransaction Date/Time (site local): 23-Jan-2026 09:14:45\n\nTransaction Date/Time (system local): 23-Jan-2026 08:14:45\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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file mode 100644 index 0000000..b265e64 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 852, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100012001 at site DD5-CZ10001", + "event": "I0", + "actual_date": "2026-02-19", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1136793\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 19-Feb-2026 07:50:32\n\nTransaction Date/Time (system local): 19-Feb-2026 06:50:32\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000000000000000000000000000000000000..6bf314afd190701453456b111e769e2197f771d8 GIT binary patch literal 24989 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"actual_date": "2026-02-20", + "subject": "CZ100222001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222001\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 20-Feb-2026\n\nTransaction Date/Time (site local): 03-Mar-2026 08:51:04\n\nTransaction Date/Time (system local): 03-Mar-2026 07:51:04\n\nTransaction performed by: katerina.havlikova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.pdf 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--git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..c64fc89 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 972, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100012002 has been created in IRT at site DD5-CZ10001", + "event": "Create", + "actual_date": "2026-02-25", + "subject": "CZ100012002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 25-Feb-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: Yes\n\nDate of Subject Creation in IRT: 25-Feb-2026\n\nTransaction Date/Time (site local): 25-Feb-2026 12:27:20\n\nTransaction Date/Time (system local): 25-Feb-2026 11:27:20\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf 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"77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100212001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 25-Feb-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 25-Feb-2026\n\nTransaction Date/Time (site local): 25-Feb-2026 11:32:00\n\nTransaction Date/Time (system local): 25-Feb-2026 10:32:00\n\nTransaction performed by: dvorakova.zdenka@nemcb.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 1001, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100132001 has been created in IRT at site DD5-CZ10013", + "event": "Create", + "actual_date": "2026-02-26", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 26-Feb-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of 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at site DD5-CZ10022", + "event": "uv_disp_conf", + "actual_date": "2026-03-09", + "subject": "CZ100222003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222003 has been performed for the following medication IDs:\n\n Medication id: 1168110\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 09-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 09-Mar-2026 08:57:02\n\nTransaction Date/Time (system local): 09-Mar-2026 07:57:02\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} 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HcmV?d00001 diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..23e55fa --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 1461, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001", + "event": "uv_disp_conf", + "actual_date": "2026-03-16", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012001 has been performed for the following medication IDs:\n\n Medication id: 1136793\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 19-Feb-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 16-Mar-2026 10:25:59\n\nTransaction Date/Time (system local): 16-Mar-2026 09:25:59\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..0a3e786 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 1548, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001", + "event": "uv_disp_conf", + "actual_date": "2026-03-18", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012001 has been performed for the following medication IDs:\n\n Medication id: 1136793\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 19-Feb-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-Mar-2026 07:25:24\n\nTransaction Date/Time (system local): 18-Mar-2026 06:25:24\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..2f6c426 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 1550, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 has been assigned medication for visit Week I-4 at site DD5-CZ10001", + "event": "I4", + "actual_date": "2026-03-18", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1068485\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1171236\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-Mar-2026 07:27:34\n\nTransaction Date/Time (system local): 18-Mar-2026 06:27:34\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.pdf 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77242113UCO3001 Subject CZ100062001 dispensing confirmation has occurred at site DD5-CZ10006", + "event": "uv_disp_conf", + "actual_date": "2026-03-20", + "subject": "CZ100062001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100062001 has been performed for the following medication IDs:\n\n Medication id: 1058454\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 20-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 20-Mar-2026 17:49:52\n\nTransaction Date/Time (system local): 20-Mar-2026 16:49:52\n\nTransaction performed by: konecnymi@seznam.cz\n\n \nIf you have questions about this notification, 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..90aa904 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 1844, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100132001 dispensing confirmation has occurred at site DD5-CZ10013", + "event": "uv_disp_conf", + "actual_date": "2026-03-30", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100132001 has been performed for the following medication IDs:\n\n Medication id: 1086141\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 24-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 30-Mar-2026 10:05:21\n\nTransaction Date/Time (system local): 30-Mar-2026 08:05:21\n\nTransaction performed by: studycoordinator@vnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf 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Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 01-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 01-Apr-2026\n\nTransaction Date/Time (site local): 01-Apr-2026 07:47:19\n\nTransaction Date/Time (system local): 01-Apr-2026 05:47:19\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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occurred at site DD5-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-04-07", + "subject": "CZ100122001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100122001 has been performed for the following medication IDs:\n\n Medication id: 1114893\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 07-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 07-Apr-2026 13:59:16\n\nTransaction Date/Time (system local): 07-Apr-2026 11:59:16\n\nTransaction performed by: laznickova.edita@fnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf new file mode 100644 index 0000000000000000000000000000000000000000..99835969192b35cd4b733085d6cbd9797d6b6a4a GIT binary patch literal 24788 zcmce-bzEG_(l&}E1Sd$a0E4>??(XjH7TlfS?(QzZEd&kjP9Q*l;Dq4reh1h&d!KXO z@4nyt=g#`AX{)NPuIjGUGyN9vn%P(j={th@5#j*S16k-<=ouK87@3&ZH7HNR^z{&usU|^wTebyMD4NE6rV{ZiVkLHsSAoc0^0neU) z5pC!Qat=r~fKFLK9QNr8K>oqe(Uyab&cVsn*2dnEmdVu6(#+b-P~Vc)(8lW7V}Dzf z0r=O@o@DCks!H<92#U!n=mG&xrd0U1IwruA&HlZP1@LSfg@4QghCiO-;`)1jf=Phs zgIR+)fG%TD3IJmTT|m%O1A;MtE=DkAFhMX`P)ZNF7(nfcU`}8LVCEod!{rN*F~5a?nCqXFslkDe)D0RYehv^TbP1TZ|!c!j45A!7$e 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 2134, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100122001 at site DD5-CZ10012", + "event": "I0", + "actual_date": "2026-04-07", + "subject": "CZ100122001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100122001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1114893\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 07-Apr-2026 11:55:52\n\nTransaction Date/Time (system local): 07-Apr-2026 09:55:52\n\nTransaction performed by: konecny.stefan@fnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.pdf new file mode 100644 index 0000000000000000000000000000000000000000..7c41cf17d13f0b533fb684c6d9b63aa28f22687b GIT binary patch literal 25004 zcmce;bzB@zvp0%sa1sc*5ZqZ{cX9XN?jGFTg9LX8!6Cujg9Vo$!GgO54Hkj~33q|y 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"study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100212001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1075956\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 07-Apr-2026 09:36:22\n\nTransaction Date/Time (system local): 07-Apr-2026 07:36:22\n\nTransaction performed by: dvorakova.zdenka@nemcb.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.pdf new file mode 100644 index 0000000000000000000000000000000000000000..d32ace80e5307539057be8237184d11fcd40e491 GIT binary patch literal 25146 zcmce-WmsIxvp0$*1c%@R8QdLaaCdii7~EY$2qXj#?hssqL(t$5+}$N;@E{3x2gv^K zz0W!CJ@5T;XFW5$y1J^mx~sdU*XmzWDv3!jvNCZXvI1BD4kp%!e0+$^YF4hcU;xeC zJuM=$s598u)xr582ju}}17!*23S|dn3;A_`a)dI2GKT^{u|P3Fu|lyyet{2n5Gf^R z2QxQQ@ROJ_gc$(E0V(2wd_jLHwQ{f*Gj@g4BgVtV!Ukjkvaqspu(NY;>Chqy2q1#( z%^vJw|EFDEj$i<@xTmY6sw+eiky%w3;Ogx5a3c?3VPauJWHvPhurjeg%ocu1g{4&i z=Ek-zk37aMHUMS?2Yc|}>N)Lb{l9GB`iqGLz^tXM z17K$d01&xY*_k+59zFm7%YRt8|0h-u=l{gY%JM(*vU2d3>)?BeF==-}+i#9?7-Yh`a`YHZ77>R|Wi 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+ "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 has been assigned medication for visit Week I-4 at site DD5-CZ10022", + "event": "I4", + "actual_date": "2026-04-08", + "subject": "CZ100222003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1072571\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1086416\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 08-Apr-2026 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DD5-CZ10022", + "event": "uv_return", + "actual_date": "2026-04-08", + "subject": "CZ100222003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100222003 has been performed.\n\n \n\n Medication id: 1168110\n Medication status: Returned by Subject\n\nReturned Inner Qty: 2\n Returned Date: 08-Apr-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n Transaction Date/Time (site local): 08-Apr-2026 08:05:54\n\n Transaction Date/Time (system local): 08-Apr-2026 06:05:54\n\n Transaction performed by: jana.pomahacova@clinoxus.com\n\n If you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..d178d57 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 2164, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100012002 at site DD5-CZ10001", + "event": "I0", + "actual_date": "2026-04-08", + "subject": "CZ100012002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012002 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1185466\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: Yes\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 08-Apr-2026 07:13:02\n\nTransaction Date/Time (system local): 08-Apr-2026 05:13:02\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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0000000..d0e745a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 2222, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100222005 at site DD5-CZ10022", + "event": "I0", + "actual_date": "2026-04-09", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222005 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1037862\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 09-Apr-2026 10:16:00\n\nTransaction Date/Time (system local): 09-Apr-2026 08:16:00\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000000000000000000000000000000000000..02b7a95497bc18a53a23732fb367e498f38ed104 GIT binary patch literal 25074 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+++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.json @@ -0,0 +1,10 @@ +{ + "pk": 2340, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100201001 has been created in IRT at site DD5-CZ10020", + "event": "Create", + "actual_date": "2026-04-13", + "subject": "CZ100201001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100201001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10020\n\nInvestigator: Lucie Gonsorcikova\n\nSubject Details\n\nSubject: CZ100201001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adolescent subjects (under 18 years)\n\nInformed Consent Date at Subject Creation: 13-Apr-2026\n\n Adolescent Assent Date: 13-Apr-2026\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..b748b9e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 2427, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100062001 has been assigned medication for visit Week I-4 at site DD5-CZ10006", + "event": "I4", + "actual_date": "2026-04-15", + "subject": "CZ100062001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1009513\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n 1194467\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 15-Apr-2026 06:41:16\n\nTransaction Date/Time (system local): 15-Apr-2026 04:41:16\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10006.pdf 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.json @@ -0,0 +1,10 @@ +{ + "pk": 2516, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100092002 has been created in IRT at site DD5-CZ10009", + "event": "Create", + "actual_date": "2026-04-16", + "subject": "CZ100092002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100092002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 16-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..77f0b7e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 2574, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100062002 has been created in IRT at site DD5-CZ10006", + "event": "Create", + "actual_date": "2026-04-20", + "subject": "CZ100062002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 20-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: Yes\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 20-Apr-2026\n\nTransaction Date/Time (site local): 20-Apr-2026 06:50:59\n\nTransaction Date/Time (system local): 20-Apr-2026 04:50:59\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf new file mode 100644 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a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..27b2f31 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 2622, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100132001 dispensing confirmation has occurred at site DD5-CZ10013", + "event": "uv_disp_conf", + "actual_date": "2026-04-21", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100132001 has been performed for the following medication IDs:\n\n Medication id: 1056051\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 21-Apr-2026\n\n Medication id: 1172586\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 21-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 07:55:26\n\nTransaction Date/Time (system local): 21-Apr-2026 05:55:26\n\nTransaction performed by: dstepek@vnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..2357b89 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 2621, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100132001 has been assigned medication for visit Week I-4 at site DD5-CZ10013", + "event": "I4", + "actual_date": "2026-04-21", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1056051\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1172586\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 07:54:13\n\nTransaction Date/Time (system local): 21-Apr-2026 05:54:13\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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+ "label": "Janssen 77242113UCO3001 Subject CZ100162001 has been created in IRT at site DD5-CZ10016", + "event": "Create", + "actual_date": "2026-04-21", + "subject": "CZ100162001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100162001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10016\n\nInvestigator: Robert Mudr\n\nSubject Details\n\nSubject: CZ100162001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 21-Apr-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 21-Apr-2026\n\nTransaction Date/Time (site local): 21-Apr-2026 09:31:12\n\nTransaction Date/Time (system local): 21-Apr-2026 07:31:12\n\nTransaction performed by: petr.pekny@nmskb.cz\n\nIf you have questions about this 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 2647, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100222005 dispensing confirmation has occurred at site DD5-CZ10022", + "event": "uv_disp_conf", + "actual_date": "2026-04-21", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222005 has been performed for the following medication IDs:\n\n Medication id: 1037862\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 09-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 11:39:52\n\nTransaction Date/Time (system local): 21-Apr-2026 09:39:52\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000000000000000000000000000000000000..a48a50065f6943db36066bd24076eabac2941c1c GIT binary patch literal 24852 zcmce-bzEG_(l&|(cXuW@1RLBvxVyvP?iwsXgF}J`2@u?aJHdk!+#P}hcfAAIIeVXT 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a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..228c205 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 2791, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100132001 has returned a medication at site DD5-CZ10013", + "event": "uv_return", + "actual_date": "2026-04-24", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-29_Janssen_77242113UCO3001_Subject_CZ100012003_has_been_created_in_IRT_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..20d2475 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-29_Janssen_77242113UCO3001_Subject_CZ100012003_has_been_created_in_IRT_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 2983, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100012003 has been created in IRT at site DD5-CZ10001", + "event": "Create", + "actual_date": "2026-04-29", + "subject": "CZ100012003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012003 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012003\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 29-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 29-Apr-2026\n\nTransaction Date/Time (site local): 29-Apr-2026 07:12:54\n\nTransaction Date/Time (system local): 29-Apr-2026 05:12:54\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-29_Janssen_77242113UCO3001_Subject_CZ100012003_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-29_Janssen_77242113UCO3001_Subject_CZ100012003_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf new file mode 100644 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medication at site DD5-CZ10021", + "event": "uv_return", + "actual_date": "2026-05-05", + "subject": "CZ100212001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100212001 has been performed.\n\n \n\n Medication id: 1075956\n Medication status: Returned by Subject\n\nReturned Inner Qty: 4\n Returned Date: 05-May-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n Transaction Date/Time (site local): 05-May-2026 10:45:49\n\n Transaction Date/Time (system local): 05-May-2026 08:45:49\n\n Transaction performed by: dvorakova.zdenka@nemcb.cz\n\n If you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git 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index 0000000..674f866 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 3158, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100222005 dispensing confirmation has occurred at site DD5-CZ10022", + "event": "uv_disp_conf", + "actual_date": "2026-05-05", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222005 has been performed for the following medication IDs:\n\n Medication id: 1006427\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 05-May-2026\n\n Medication id: 1198359\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 05-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 05-May-2026 07:31:14\n\nTransaction Date/Time (system local): 05-May-2026 05:31:14\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf new file mode 100644 index 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file mode 100644 index 0000000..5d4f6fe --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 3157, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100222005 has returned a medication at site DD5-CZ10022", + "event": "uv_return", + "actual_date": "2026-05-05", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100222005 has been performed.\n\n \n\n Medication id: 1037862\n Medication status: Returned by Subject\n\nReturned Inner Qty: 6\n Returned Date: 05-May-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects 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"I0", + "actual_date": "2026-05-05", + "subject": "CZ100092001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100092001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1126645\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 05-May-2026 11:30:28\n\nTransaction Date/Time (system local): 05-May-2026 09:30:28\n\nTransaction performed by: kolackova@vilazdravi.cz\n\nIf you have questions about 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.json new file mode 100644 index 0000000..31cbd50 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.json @@ -0,0 +1,10 @@ +{ + "pk": 3240, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100012002 dispensing confirmation has occurred at site DD5-CZ10001", + "event": "uv_disp_conf", + "actual_date": "2026-05-06", + "subject": "CZ100012002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012002 has been performed for the following medication IDs:\n\n Medication id: 1089193\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 06-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 06-May-2026 10:54:55\n\nTransaction Date/Time (system local): 06-May-2026 08:54:55\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.pdf 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3218, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100012002 has been assigned medication for visit Week I-4 at site DD5-CZ10001", + "event": "I4", + "actual_date": "2026-05-06", + "subject": "CZ100012002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012002 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1089193\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1094427\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 06-May-2026 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 3315, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100122001 dispensing confirmation has occurred at site DD5-CZ10012", + "event": "uv_disp_conf", + "actual_date": "2026-05-07", + "subject": "CZ100122001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100122001 has been performed for the following medication IDs:\n\n Medication id: 1071968\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 07-May-2026\n\n Medication id: 1154616\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 07-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 07-May-2026 14:55:41\n\nTransaction Date/Time (system local): 07-May-2026 12:55:41\n\nTransaction performed by: laznickova.edita@fnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf new file mode 100644 index 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"subject": "CZ100122001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100122001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1071968\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n 1154616\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 07-May-2026 12:25:24\n\nTransaction Date/Time (system local): 07-May-2026 10:25:24\n\nTransaction performed by: konecny.stefan@fnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10012.pdf new file mode 100644 index 0000000000000000000000000000000000000000..02bede34e3b7e5ae2461dbfc200ace35cecd8e09 GIT binary patch literal 25239 zcmce-bzB_H(m#rOfZ)#J7Ic@z-66OW+#$F_aCd?`1PH-NaCZw12_7Ig3GSY77szv- z=e+0q?)$s{+?~&CPghsfRCjgP^h|%7MoCgO0Dee#Eo1a_YvpiVB-L@f!WyEK|m0QM~4ALP!Pq; z&h)_^;6Ls1bT9+3N_e06PmC#B7nLR76G< zU~XjN{K#YE{2IWjU~gykw|dYY^{-f!j9gsIoa_Ls;%07ECT1#9qI!SX!2K5!8-P_y zTL%CH0stu7>_8Sywuc`8!1gazp8v+m#rfY@+1dUpFFWYJsAc~*_dGU(h@G9i3#8_* 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 3512, + "title": "Assignment_i12_m0", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 has been assigned medication for visit Week I-12 / M-0 at site DD5-CZ10001", + "event": "M0", + "actual_date": "2026-05-13", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been assigned the following medication(s) for visit Week I-12 / M-0:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1168586\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nClinical Response at I-12 / M-0: Clinical Responder\n\n Concomitant Use of Corticosteroids: Yes\n\n Clinical Remission: Yes\n\nTransaction Date/Time (site local): 13-May-2026 08:23:23\n\nTransaction Date/Time (system local): 13-May-2026 06:23:23\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10001.pdf new 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"77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092002\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 15-May-2026\n\nTransaction Date/Time (site local): 15-May-2026 15:17:00\n\nTransaction Date/Time (system local): 15-May-2026 13:17:00\n\nTransaction performed by: kolackova@vilazdravi.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-15_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_screen_failed_at_site_DD5-CZ10009.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-15_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_screen_failed_at_site_DD5-CZ10009.pdf new file mode 100644 index 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CZ100080001 has been discontinued from IRT managed treatment at site S10-CZ10008", + "event": "uv_discontinue", + "actual_date": "2025-11-05", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Subject CZ100080001 has been Discontinued from IRT Managed Treatment.\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\nDiscontinuation date: 05-Nov-2025 \nTransaction Date/Time (site local): 05-Nov-2025 13:15:29\nTransaction Date/Time (system local): 05-Nov-2025 12:15:29\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..99be412 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 11411, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 Rolled Over from Part 1 into Part 2 at site S10-CZ10004", + "event": "DB_P1_V7", + "actual_date": "2025-11-14", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been rolled over into part 2.\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): 14-Nov-2025 11:46:38\nTransaction Date/Time (system local): 14-Nov-2025 10:46:38\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.pdf new file mode 100644 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json new file mode 100644 index 0000000..041c633 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-14_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 11412, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10004", + "event": "DB_P1_V7", + "actual_date": "2025-11-14", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1039573Seltorexant 20mg or placeboT38028505-Apr-20261199588Seltorexant 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): 14-Nov-2025 11:46:38 \nTransaction Date/Time (system local): 14-Nov-2025 10:46:38 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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"pk": 11949, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1050820\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1156231\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 26-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 24-Nov-2025 14:14:58\n\nTransaction Date/Time (system local): 24-Nov-2025 13:14:58 \nTransaction performed by: studie@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000000000000000000000000000000000000..f3f4ff808823c20747449930d1d3dc117d2424d4 GIT binary patch literal 24829 zcmce81ymi+(kFxvEI{z!H@M3ME*hNR?(XjH7Ti4nf=h7MV8NXr3GNWw-C-~AxA(rc 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"2025-11-24", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1092399\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 11-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1141877\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 11-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 24-Nov-2025 14:16:08\n\nTransaction Date/Time (system local): 24-Nov-2025 13:16:08 \nTransaction performed by: 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.json @@ -0,0 +1,10 @@ +{ + "pk": 11959, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-11-24", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110001 has been performed.\nMedication ID: 1050820\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1156231\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 5\n\nMedication ID: 1092399\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1141877\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 24-Nov-2025 14:36:04 \nTransaction Date/Time (system local): 24-Nov-2025 13:36:04 \nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..2355d63 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11948, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1040913\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Aug-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Nov-2025 13:25:05\n\nTransaction Date/Time (system local): 24-Nov-2025 12:25:05 \nTransaction performed by: studie@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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index 0000000..e18872f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.json @@ -0,0 +1,10 @@ +{ + "pk": 11951, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1204821\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1219896\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1220734\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1288601\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 06-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Nov-2025 14:17:10\n\nTransaction Date/Time (system local): 24-Nov-2025 13:17:10 \nTransaction performed by: studie@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1216273\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1258223\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 22-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Nov-2025 14:18:01\n\nTransaction Date/Time (system local): 24-Nov-2025 13:18:01 \nTransaction performed by: studie@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.pdf new file mode 100644 index 0000000000000000000000000000000000000000..17ab6d18f5d23dab6c22a61b439a83f8864cade7 GIT binary patch literal 24787 zcmce-1z24>w>G+vqQ#ves}w8F!X1h`#oeX2TXArqS}5-BPI3De(EaWG zedql5ocrA8xh&>PW->A|GDb#{nY@!sPDq57k&YRG5y$|v);B}o=0>1bGT zyhWfFv@_Cku(o@A0yqQA0UrPk084-c_-+lb0T=>|0YCr)fDXV20DdC_-Tf62i97ZC%HUR6yU z$ixH$BCs%2%lL2Rc~XObm6f#vxaE%e 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CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1236395\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1260207\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 09-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Nov-2025 14:18:46\n\nTransaction Date/Time 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.json new file mode 100644 index 0000000..1044c8c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.json @@ -0,0 +1,10 @@ +{ + "pk": 11954, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1095351\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 24-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1109959\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 24-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 24-Nov-2025 14:19:42\n\nTransaction Date/Time (system local): 24-Nov-2025 13:19:42 \nTransaction performed by: studie@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git 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"uv_return", + "actual_date": "2025-11-25", + "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: 1244191\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1272627\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:32:42 \nTransaction Date/Time (system local): 25-Nov-2025 07:32:42 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.json @@ -0,0 +1,10 @@ +{ + "pk": 12038, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-11-25", + "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: 1285194\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nMedication ID: 1297199\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 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..d3d6070 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12577, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.2 at site S10-CZ10011", + "event": "OL_TS_V2_2", + "actual_date": "2025-12-04", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been assigned the 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has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10004", + "event": "OL_Ind_V1_4", + "actual_date": "2025-12-12", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1210651Seltorexant 20mgT37484802-May-20261235923Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 12-Dec-2025 11:02:28 \nTransaction Date/Time (system local): 12-Dec-2025 10:02:28 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at 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"42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100040002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1210651\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 12-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1235923\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 12-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 15-Dec-2025 09:14:34\n\nTransaction Date/Time (system local): 15-Dec-2025 08:14:34 \nTransaction performed by: veronika@brezinova.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..3698d7e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13151, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-12-15", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100040002 has been performed.\nMedication ID: 1229547\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1247278\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: CZ100040002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 15-Dec-2025 09:15:14 \nTransaction Date/Time (system local): 15-Dec-2025 08:15:14 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 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a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..591ba44 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13299, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-17", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100110002 has\nbeen performed for the following medication IDs:\n\nMedication No: 1264624\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1270141\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 17-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10011 \nInvestigator: Lendlova, Marta \n\nSubject Details \nSubject:\nCZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Dec-2025 08:37:49\n\nTransaction Date/Time (system local): 17-Dec-2025 07:37:49 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No 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"Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Treatment Stabilization Visit 2.3 at site S10-CZ10011", + "event": "OL_TS_V2_3", + "actual_date": "2025-12-17", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been assigned the following medication(s) for visit Open Label Treatment Stabilization Visit 2.3:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1264624Seltorexant 20mgT37484802-May-20261270141Seltorexant 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): 17-Dec-2025 08:24:56 \nTransaction Date/Time (system local): 17-Dec-2025 07:24:56 \nTransaction performed by: truhlarova@medipa.org\n \nIf you 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