diff --git a/IWRS/Patients/CONTEXT.md b/IWRS/Patients/CONTEXT.md new file mode 100644 index 0000000..8e0a7d5 --- /dev/null +++ b/IWRS/Patients/CONTEXT.md @@ -0,0 +1,56 @@ +# Kontext práce — IWRS Notifications Pipeline +## Datum: 2026-06-01 + +## Co bylo uděláno + +### Nové soubory +- `download_subject_notifications.py` — standalone skript pro stažení notifikací (referenční, nepoužívaný v pipeline) +- `test_notifications.py` — testovací skript pro 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 0000000..c622836 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReports/2026-06-01 42847922MDD3003 Subject 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-02_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..03c4fa3 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-02_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 5296, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-07-02", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080001 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Jul-2025 \n\nDate of Screening in IRT: 02-Jul-2025 \nTransaction Date/Time (site local): 02-Jul-2025 09:00:54\nTransaction Date/Time (system local): 02-Jul-2025 07:00:54\n\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-02_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-02_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..26b841f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-07-02_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git 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\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 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-03_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_screened_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 6488, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been screened at site S10-CZ10011", + "event": "Screen", + "actual_date": "2025-08-03", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110001 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 01-Aug-2025 \n\nDate of Screening in IRT: 03-Aug-2025 \nTransaction Date/Time (site local): 03-Aug-2025 09:20:50\nTransaction Date/Time (system local): 03-Aug-2025 07:20:50\n\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-03_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_screened_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-03_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_screened_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8d08c1e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-03_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.json new file mode 100644 index 0000000..3708446 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 6611, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100080003 has been screened at site S10-CZ10008", + "event": "Screen", + "actual_date": "2025-08-06", + "subject": "CZ100080003", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080003 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080003 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 05-Aug-2025 \n\nDate of Screening in IRT: 06-Aug-2025 \nTransaction Date/Time (site local): 06-Aug-2025 10:05:11\nTransaction Date/Time (system local): 06-Aug-2025 08:05:11\n\nTransaction performed by: m.deif@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..08cb3a1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screened_at_site_S10-CZ10008.pdf differ diff --git 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 0000000..16a2840 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.json new file mode 100644 index 0000000..95d2eb7 --- /dev/null +++ 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 0000000..c47e614 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-06_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screened_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new 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 new file mode 100644 index 0000000..ba2f607 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git 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 \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_pk6955.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk6955.pdf new file mode 100644 index 0000000..4efb6a5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk6955.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8127.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8127.json new file mode 100644 index 0000000..a3e12b8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8127.json @@ -0,0 +1,10 @@ +{ + "pk": 8127, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-08-13", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1204917\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 10-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1237507\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 10-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 10-Sep-2025 11:42:48\n\nTransaction Date/Time (system local): 10-Sep-2025 09:42:48 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ 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_pk8127.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8127.pdf new file mode 100644 index 0000000..d0e085c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8127.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.json 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.pdf new file mode 100644 index 0000000..7e7ad4f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk8256.pdf differ diff --git a/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 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 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1010861Seltorexant 20mg or placeboT38028505-Apr-20261164714Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025 12:25:18 \nTransaction Date/Time (system local): 13-Aug-2025 10:25:18 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/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.pdf 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.pdf new file mode 100644 index 0000000..ddac92d Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..7bfa055 --- /dev/null +++ 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: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 13-Aug-2025 12:51:00 \nTransaction Date/Time (system local): 13-Aug-2025 10:51:00 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..b13b511 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.json new file mode 100644 index 0000000..85eb465 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.json @@ -0,0 +1,10 @@ +{ + "pk": 12034, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-08-13", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080001 has been performed.\nMedication ID: 1045106\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1094105\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:26:14 \nTransaction Date/Time (system local): 25-Nov-2025 07:26:14 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.pdf new file mode 100644 index 0000000..f9eb1b7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-13_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12034.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.json new file mode 100644 index 0000000..8eb3d1c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7378, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100080003 has been screen failed at site S10-CZ10008", + "event": "uv_screen_fail", + "actual_date": "2025-08-25", + "subject": "CZ100080003", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080003 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 25-Aug-2025\nTransaction Date/Time (site local): 25-Aug-2025 15:19:47\nTransaction Date/Time (system local): 25-Aug-2025 13:19:47\nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ 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 0000000..4ce4345 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-25_Janssen_42847922MDD3003_Subject_CZ100080003_has_been_screen_failed_at_site_S10-CZ10008.pdf differ 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.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 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.pdf new file mode 100644 index 0000000..22e2292 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..3bf3096 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9024.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9024.json new file mode 100644 index 0000000..de913d3 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9024.json @@ -0,0 +1,10 @@ +{ + "pk": 9024, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-08-27", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1251872\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Not Dispensed\nDispensation date: \nNote (only collected if Not Dispensed):\n \n\nMedication No: 1294645\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Not Dispensed\nDispensation date: \nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Sep-2025 11:52:55\n\nTransaction Date/Time (system local): 29-Sep-2025 09:52:55 \nTransaction performed by: v.smidkova@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ 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_pk9024.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9024.pdf new file mode 100644 index 0000000..8d9c64a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008_pk9024.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json new file mode 100644 index 0000000..7009396 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7504, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10008", + "event": "DB_P1_V7", + "actual_date": "2025-08-27", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080001 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1045106Seltorexant 20mg or placeboT38028505-Apr-20261094105Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Completed Part 1 from IRT Managed Treatment \n\nTransaction Date/Time (site local): 27-Aug-2025 11:08:36 \nTransaction Date/Time (system local): 27-Aug-2025 09:08:36 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..fa78cd9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..a21d9d8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 7500, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-08-27", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080001 has been performed.\nMedication ID: 1010861\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1164714\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 27-Aug-2025 10:48:18 \nTransaction Date/Time (system local): 27-Aug-2025 08:48:18 \nTransaction performed by: b.sollova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..2208c9b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.json new file mode 100644 index 0000000..ab34a3e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.json @@ -0,0 +1,10 @@ +{ + "pk": 12035, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has returned a medication at site S10-CZ10008", + "event": "uv_return", + "actual_date": "2025-08-27", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100080001 has been performed.\nMedication ID: 1204917\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1237507\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:31:27 \nTransaction Date/Time (system local): 25-Nov-2025 07:31:27 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.pdf new file mode 100644 index 0000000..dbc2179 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-27_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12035.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..bc4d72d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 7589, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 randomized into Part 1 at site S10-CZ10011", + "event": "Rand", + "actual_date": "2025-08-28", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110001 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1150031Seltorexant 20mg or placeboT38028505-Apr-20261194071Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 28-Aug-2025 09:34:17\nTransaction Date/Time (system local): 28-Aug-2025 07:34:17\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..427ff2e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110001_randomized_into_Part_1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c7b91a6 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 7595, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 randomized into Part 1 at site S10-CZ10011", + "event": "Rand", + "actual_date": "2025-08-28", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1040913Seltorexant 20mg or placeboT38028505-Apr-20261060564Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 28-Aug-2025 11:24:07\nTransaction Date/Time (system local): 28-Aug-2025 09:24:07\nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..6ea6f64 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100110002_randomized_into_Part_1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.json new file mode 100644 index 0000000..d53ad9f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 7594, + "title": "Screenfail", + "label": "Janssen 42847922MDD3003 Subject CZ100120001 has been screen failed at site S10-CZ10012", + "event": "uv_screen_fail", + "actual_date": "2025-08-28", + "subject": "CZ100120001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSite Details \nLocation: CZE \nSite: S10-CZ10012 \nInvestigator: Urban, Ales \n\n \nSubject Details \nSubject: CZ100120001 \nIRT Subject Status: Screen Failed \n\nScreenfail Date: 28-Aug-2025\nTransaction Date/Time (site local): 28-Aug-2025 10:59:13\nTransaction Date/Time (system local): 28-Aug-2025 08:59:13\nTransaction performed by: marcelasedlackova@seznam.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.pdf new file mode 100644 index 0000000..cc2d439 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-08-28_Janssen_42847922MDD3003_Subject_CZ100120001_has_been_screen_failed_at_site_S10-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.json new file mode 100644 index 0000000..b32aeaf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.json @@ -0,0 +1,10 @@ +{ + "pk": 8053, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100050001 has been screened at site S10-CZ10005", + "event": "Screen", + "actual_date": "2025-09-09", + "subject": "CZ100050001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100050001 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10005 \nInvestigator: Janů, Luboš \n\n \nSubject Details \nSubject: CZ100050001 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 09-Sep-2025 \n\nDate of Screening in IRT: 09-Sep-2025 \nTransaction Date/Time (site local): 09-Sep-2025 10:47:27\nTransaction Date/Time (system local): 09-Sep-2025 08:47:27\n\nTransaction performed by: spinkova@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ 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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.pdf new file mode 100644 index 0000000..5f57c12 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-09_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screened_at_site_S10-CZ10005.pdf differ diff --git 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 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.pdf 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.pdf new file mode 100644 index 0000000..9ed203b Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json new file mode 100644 index 0000000..d7d1169 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 8123, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011", + "event": "DB_P1_V6", + "actual_date": "2025-09-10", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1007696Seltorexant 20mg or placeboT38028505-Apr-20261123387Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 10-Sep-2025 10:03:19 \nTransaction Date/Time (system local): 10-Sep-2025 08:03:19 \nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..72ef1d9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-10_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..bd90735 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 8194, + "title": "Medication_replacement", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has replaced a medication at site S10-CZ10008", + "event": "uv_replace", + "actual_date": "2025-09-11", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nMedication(s) have/has been replaced for Subject CZ100080001. \n\nThe replaced medication ID: 1204917\n 1237507\n\nPlease assign the following medication(s) to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1244191Seltorexant 20mgT37484802-May-20261272627Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 11-Sep-2025 14:58:12 \nTransaction Date/Time (system local): 11-Sep-2025 12:58:12 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..eb806d2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100080001_has_replaced_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json new file mode 100644 index 0000000..13a186b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 8193, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10011", + "event": "DB_P1_V6", + "actual_date": "2025-09-11", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110001 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1092399Seltorexant 20mg or placeboT38028505-Apr-20261141877Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 11-Sep-2025 14:05:40 \nTransaction Date/Time (system local): 11-Sep-2025 12:05:40 \nTransaction performed by: studie@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..53a8de9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-11_Janssen_42847922MDD3003_Subject_CZ100110001_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d171bb0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 8626, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been screened at site S10-CZ10004", + "event": "Screen", + "actual_date": "2025-09-19", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 19-Sep-2025 \n\nDate of Screening in IRT: 19-Sep-2025 \nTransaction Date/Time (site local): 19-Sep-2025 08:45:25\nTransaction Date/Time (system local): 19-Sep-2025 06:45:25\n\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..d11f6c0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_screened_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.json 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 0000000..f5a5695 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-19_Janssen_42847922MDD3003_Subject_CZ100050001_has_been_screen_failed_at_site_S10-CZ10005.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..8715d96 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 8843, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 Rolled Over from Part 1 into Part 2 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2025-09-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 24-Sep-2025 14:01:14\nTransaction Date/Time (system local): 24-Sep-2025 12:01:14\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..dce9c14 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json new file mode 100644 index 0000000..0124a74 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 8844, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Double Blind Part 1 Visit 7 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2025-09-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been assigned the following medication(s) for visit Double Blind Part 1 Visit 7:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1095351Seltorexant 20mg or placeboT38028505-Apr-20261109959Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 24-Sep-2025 14:01:13 \nTransaction Date/Time (system local): 24-Sep-2025 12:01:13 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..3345eba Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_7_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json new file mode 100644 index 0000000..74bc12a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 8954, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100110001 Rolled Over from Part 1 into Part 2 at site S10-CZ10011", + "event": "DB_P1_V7", + "actual_date": "2025-09-26", + "subject": "CZ100110001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110001 has been rolled over into part 2.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Sep-2025 11:28:23\nTransaction Date/Time (system local): 26-Sep-2025 09:28:23\n\nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..dd12401 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-26_Janssen_42847922MDD3003_Subject_CZ100110001_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10011.pdf differ diff --git a/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 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 new file mode 100644 index 0000000..55006b8 --- /dev/null +++ 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 \nSubject: CZ100110001 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 26-Sep-2025 11:28:23 \nTransaction Date/Time (system local): 26-Sep-2025 09:28:23 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/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.pdf 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.pdf new file mode 100644 index 0000000..57c7b88 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json new file mode 100644 index 0000000..2f80007 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9023, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 has been assigned medication for visit Open Label Induction Visit 1.4 at site S10-CZ10008", + "event": "OL_Ind_V1_4", + "actual_date": "2025-09-29", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100080001 has been assigned the following medication(s) for visit Open Label Induction Visit 1.4:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1251872Seltorexant 20mgT37484802-May-20261294645Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10008 \nInvestigator: Solle, Zdenek \n\n \nSubject Details \nSubject: CZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 29-Sep-2025 11:49:43 \nTransaction Date/Time (system local): 29-Sep-2025 09:49:43 \nTransaction performed by: v.smidkova@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..844ae92 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-09-29_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json new file mode 100644 index 0000000..ee1aa5c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 9514, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100080001 dispensing confirmation has occurred at site S10-CZ10008", + "event": "uv_disp_conf", + "actual_date": "2025-10-08", + "subject": "CZ100080001", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\n Confirmation of dispensing medication(s) for Subject CZ100080001 has\nbeen performed for the following medication IDs:\n\nMedication No: 1270859\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1284666\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 08-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10008 \nInvestigator: Solle, Zdenek \n\nSubject Details \nSubject:\nCZ100080001 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 08-Oct-2025 13:02:10\n\nTransaction Date/Time (system local): 08-Oct-2025 11:02:10 \nTransaction performed by: m.deif@clintrial.cz\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ 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 0000000..cf2fc68 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-08_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ 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.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 0000000..1c8ddbd Binary files /dev/null and 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 differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json new file mode 100644 index 0000000..1733424 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 9566, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10011", + "event": "OL_Ind_V1_1", + "actual_date": "2025-10-09", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100110002 has been assigned the following medication(s) for visit Open Label Induction Visit 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1236395Seltorexant 20mgT37484802-May-20261260207Seltorexant 20mgT37484802-May-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 09-Oct-2025 08:29:29 \nTransaction Date/Time (system local): 09-Oct-2025 06:29:29 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..8704391 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-09_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..671a107 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 9972, + "title": "Randomized_Part_1", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 randomized into Part 1 at site S10-CZ10004", + "event": "Rand", + "actual_date": "2025-10-17", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040002 has been randomized into Part 1.\n \nThe following medication(s) has been assigned to the subject:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1078186Seltorexant 20mg or placeboT38028505-Apr-20261129823Seltorexant 20mg or placeboT38028505-Apr-2026\n\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 17-Oct-2025 13:40:42\nTransaction Date/Time (system local): 17-Oct-2025 11:40:42\nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..802f4eb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-17_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_1_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..88646d8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10014, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "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: 1078186\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1129823\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 17-Oct-2025\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 1 \n\nTransaction Date/Time (site local): 20-Oct-2025 09:49:47\n\nTransaction Date/Time (system local): 20-Oct-2025 07:49:47 \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.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..6444edb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.json new file mode 100644 index 0000000..a8b507b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.json @@ -0,0 +1,10 @@ +{ + "pk": 11613, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "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 0000000..f769f6f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-20_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk11613.pdf differ diff --git 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 end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..b2fe775 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-10-22_Janssen_42847922MDD3003_Subject_CZ100080001_dispensing_confirmation_has_occurred_at_site_S10-CZ10008.pdf differ 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 0000000..feb54b0 Binary files /dev/null and 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 differ 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.json 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 0000000..d4d56bb Binary files /dev/null and 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 differ diff --git a/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 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 new file mode 100644 index 0000000..83389dd --- /dev/null +++ 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: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 22-Oct-2025 10:08:35 \nTransaction Date/Time (system local): 22-Oct-2025 08:08:35 \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_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10011.pdf 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.pdf new file mode 100644 index 0000000..528ba30 Binary files /dev/null and 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.pdf differ diff --git a/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 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 Visit 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1012490Seltorexant 20mg or placeboT38028505-Apr-20261146893Seltorexant 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): 31-Oct-2025 11:40:46 \nTransaction Date/Time (system local): 31-Oct-2025 10:40:46 \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/2025-10-31_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf 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.pdf new file mode 100644 index 0000000..c50fc85 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d992e26 --- /dev/null +++ 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 0000000..e1310f3 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk12318.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk12318.json new file mode 100644 index 0000000..97cf508 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk12318.json @@ -0,0 +1,10 @@ +{ + "pk": 12318, + "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: 1229547\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 28-Nov-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1247278\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 28-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: Enrolled Open Label \n\nTransaction Date/Time (site local): 01-Dec-2025 09:25:57\n\nTransaction Date/Time (system local): 01-Dec-2025 08:25:57 \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_pk12318.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk12318.pdf new file mode 100644 index 0000000..93d9c70 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk12318.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..69d9d45 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 10744, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-11-03", + "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: 1078186\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1129823\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 1 \n\nTransaction Date/Time (site local): 03-Nov-2025 09:33:09 \nTransaction Date/Time (system local): 03-Nov-2025 08:33:09 \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/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..0bf42c7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.json new file mode 100644 index 0000000..94bb5ff --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.json @@ -0,0 +1,10 @@ +{ + "pk": 11612, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-11-03", + "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: 1012490\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1146893\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 1 \n\nTransaction Date/Time (site local): 18-Nov-2025 09:30:38 \nTransaction Date/Time (system local): 18-Nov-2025 08:30:38 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.pdf new file mode 100644 index 0000000..db57f90 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-03_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004_pk11612.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json new file mode 100644 index 0000000..bde8fd0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 10921, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..d6c6db7 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-05_Janssen_42847922MDD3003_Subject_CZ100080001_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json new file mode 100644 index 0000000..1dfef3b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 10969, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10011", + "event": "OL_Ind_V1_5", + "actual_date": "2025-11-06", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100110002 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 1204821\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1219896\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1220734\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1288601\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10011 \n\r\n Investigator: Lendlova, Marta \n\n \n\r\n Subject Details \nSubject: CZ100110002 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Manual\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 06-Nov-2025 08:12:40 \n\r\n Transaction Date/Time (system local): 06-Nov-2025 07:12:40 \n\r\n Transaction performed by: truhlarova@medipa.org\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..b4ccccf Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-06_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/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 index 0000000..2006c31 Binary files /dev/null and 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 differ diff --git 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 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.pdf 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.pdf new file mode 100644 index 0000000..371d635 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..d1c3148 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "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 0000000..f3f4ff8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11950.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11950.json new file mode 100644 index 0000000..ae857b5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11950.json @@ -0,0 +1,10 @@ +{ + "pk": 11950, + "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: 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: 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_pk11950.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11950.pdf new file mode 100644 index 0000000..2038621 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11950.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11956.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11956.json new file mode 100644 index 0000000..ddf145a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11956.json @@ -0,0 +1,10 @@ +{ + "pk": 11956, + "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: 1150031\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\nMedication No: 1194071\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:\nCZ100110001 \nIRT Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 24-Nov-2025 14:22:28\n\nTransaction Date/Time (system local): 24-Nov-2025 13:22:28 \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_pk11956.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11956.pdf new file mode 100644 index 0000000..2656d9c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11956.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..e1ba161 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11957, + "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: 1150031\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1194071\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 14:28:35 \nTransaction Date/Time (system local): 24-Nov-2025 13:28:35 \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.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..25529fd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.json new file mode 100644 index 0000000..60b098f --- /dev/null +++ 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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.pdf new file mode 100644 index 0000000..c25c2ff Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110001_has_returned_a_medication_at_site_S10-CZ10011_pk11959.pdf differ diff --git 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..653590a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.json new file mode 100644 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.pdf new file mode 100644 index 0000000..137e994 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11951.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.json new file mode 100644 index 0000000..0fe6b1a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.json @@ -0,0 +1,10 @@ +{ + "pk": 11952, + "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: 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 0000000..17ab6d1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11952.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11953.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11953.json new file mode 100644 index 0000000..e1737c0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11953.json @@ -0,0 +1,10 @@ +{ + "pk": 11953, + "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: 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 (system local): 24-Nov-2025 13:18:46 \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_pk11953.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11953.pdf new file mode 100644 index 0000000..4ff75df Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11953.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.json 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.pdf new file mode 100644 index 0000000..9a3e69d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11954.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11955.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11955.json new file mode 100644 index 0000000..31827ed --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11955.json @@ -0,0 +1,10 @@ +{ + "pk": 11955, + "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: 1060564\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\nMedication No: 1123387\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-Sep-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1007696\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 10-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 14:21:23\n\nTransaction Date/Time (system local): 24-Nov-2025 13:21:23 \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_pk11955.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11955.pdf new file mode 100644 index 0000000..2ed9c2e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011_pk11955.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..a968cd1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 11960, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-11-24", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110002 has been performed.\nMedication ID: 1216273\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1258223\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 2\n\nMedication ID: 1236395\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1260207\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nMedication ID: 1095351\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1109959\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1007696\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1123387\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1040913\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1060564\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 4\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): 24-Nov-2025 14:49:42 \nTransaction Date/Time (system local): 24-Nov-2025 13:49:42 \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_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..83238fb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-24_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json new file mode 100644 index 0000000..e20322f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.json @@ -0,0 +1,10 @@ +{ + "pk": 12036, + "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: 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 end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf new file mode 100644 index 0000000..8e72873 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.json new file mode 100644 index 0000000..e1b0b9a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.json @@ -0,0 +1,10 @@ +{ + "pk": 12037, + "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: 1270859\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nMedication ID: 1284666\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 08:34:07 \nTransaction Date/Time (system local): 25-Nov-2025 07:34:07 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.pdf new file mode 100644 index 0000000..87fd3d2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12037.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.json new file mode 100644 index 0000000..db5b24d --- /dev/null +++ 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 Subject Status: Discontinued from IRT Managed Treatment \n\nTransaction Date/Time (site local): 25-Nov-2025 08:35:16 \nTransaction Date/Time (system local): 25-Nov-2025 07:35:16 \nTransaction performed by: r.gregar@clintrial.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.pdf new file mode 100644 index 0000000..e3e93e2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-25_Janssen_42847922MDD3003_Subject_CZ100080001_has_returned_a_medication_at_site_S10-CZ10008_pk12038.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..91197e7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 12268, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Open Label Induction Visit 1.1 at site S10-CZ10004", + "event": "OL_Ind_V1_1", + "actual_date": "2025-11-28", + "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 1.1:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1229547Seltorexant 20mgT37484802-May-20261247278Seltorexant 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): 28-Nov-2025 10:38:49 \nTransaction Date/Time (system local): 28-Nov-2025 09:38:49 \nTransaction performed by: gnovotna@email.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c4b722e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-11-28_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.1_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..795bb74 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 12319, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2025-12-01", + "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: 1039573\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1199588\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: Enrolled Open Label \n\nTransaction Date/Time (site local): 01-Dec-2025 09:27:13 \nTransaction Date/Time (system local): 01-Dec-2025 08:27:13 \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/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..89e827e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json new file mode 100644 index 0000000..811af6c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12613, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 dispensing confirmation has occurred at site S10-CZ10011", + "event": "uv_disp_conf", + "actual_date": "2025-12-04", + "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: 1278618\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 04-Dec-2025\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1296192\n\nProduct Label Type: Seltorexant 20mg\nMedication status:\n Dispensed\nDispensation date: 04-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): 04-Dec-2025 18:02:13\n\nTransaction Date/Time (system local): 04-Dec-2025 17:02:13 \nTransaction performed by: truhlarova@medipa.org\n\nIf you have\nquestions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..83e18ad Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/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 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 following medication(s) for visit Open Label Treatment Stabilization Visit 2.2:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1278618Seltorexant 20mgT37484802-May-20261296192Seltorexant 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): 04-Dec-2025 07:54:50 \nTransaction Date/Time (system local): 04-Dec-2025 06:54:50 \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/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.2_at_site_S10-CZ10011.pdf 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.pdf new file mode 100644 index 0000000..822336f Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..8ec7604 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 12614, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-12-04", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110002 has been performed.\nMedication ID: 1204821\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1219896\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1220734\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1288601\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 04-Dec-2025 18:05:12 \nTransaction Date/Time (system local): 04-Dec-2025 17:05:12 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..c77e867 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-04_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json new file mode 100644 index 0000000..0acccb4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13093, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 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 \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..5ce8cf8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.4_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..c62316b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 13150, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2025-12-15", + "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: 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 \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_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..a240909 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json 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 0000000..4a51fa8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-15_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git 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 newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..d0ec199 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_dispensing_confirmation_has_occurred_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json new file mode 100644 index 0000000..c1444d5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13295, + "title": "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 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/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..0bec8d0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_assigned_medication_for_visit_Open_Label_Treatment_Stabilization_Visit_2.3_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..2d2d9d9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 13298, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2025-12-17", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110002 has been performed.\nMedication ID: 1278618\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 4\n\nMedication ID: 1296192\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 17-Dec-2025 08:36:45 \nTransaction Date/Time (system local): 17-Dec-2025 07:36:45 \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/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..7086ff2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-17_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json new file mode 100644 index 0000000..27c5476 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 14063, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Open Label Induction Visit 1.5 at site S10-CZ10004", + "event": "OL_Ind_V1_5", + "actual_date": "2025-12-30", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100040002 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 1219546\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1246616\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10004 \n\r\n Investigator: Herman, Erik \n\n \n\r\n Subject Details \nSubject: CZ100040002 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? No\n\n\r\n Transaction Date/Time (site local): 30-Dec-2025 12:33:08 \n\r\n Transaction Date/Time (system local): 30-Dec-2025 11:33:08 \n\r\n Transaction performed by: erik.herman@seznam.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..db6d74d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2025-12-30_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.5_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json new file mode 100644 index 0000000..bd678c1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 14135, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has returned a medication at site S10-CZ10011", + "event": "uv_return", + "actual_date": "2026-01-02", + "subject": "CZ100110002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\n\n Action to return medication(s) for Subject CZ100110002 has been performed.\nMedication ID: 1264624\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 3\n\nMedication ID: 1270141\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 1\n\nSite Details \nLocation: CZE \nSite: S10-CZ10011 \nInvestigator: Lendlova, Marta \n\n \nSubject Details \nSubject: CZ100110002 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 02-Jan-2026 11:31:12 \nTransaction Date/Time (system local): 02-Jan-2026 10:31:12 \nTransaction performed by: truhlarova@medipa.org\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..b5020e1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-02_Janssen_42847922MDD3003_Subject_CZ100110002_has_returned_a_medication_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.json new file mode 100644 index 0000000..7b52bae --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 14586, + "title": "Assignment_MADRS", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has been assigned medication for visit Open Label Induction Visit 1.6 at site S10-CZ10004", + "event": "OL_Ind_V1_6", + "actual_date": "2026-01-09", + "subject": "CZ100040002", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticals\r\nhttps://janssen.4gclinical.com\r\n\nSubject CZ100040002 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 1229478\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1230246\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1260356\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n1278762\r\n Seltorexant 20mg\r\n T374848\r\n 02-May-2026\r\n\r\n\n \nSite Details \n\r\n Location: CZE \n\r\n Site: S10-CZ10004 \n\r\n Investigator: Herman, Erik \n\n \n\r\n Subject Details \nSubject: CZ100040002 \n\r\n IRT Subject Status: Enrolled Open Label \n\n\r\n Source of data: Integrated\n\r\n Has the Subject reached the MADRS response criteria? Yes\n\n\r\n Transaction Date/Time (site local): 09-Jan-2026 11:21:26 \n\r\n Transaction Date/Time (system local): 09-Jan-2026 10:21:26 \n\r\n Transaction performed by: gnovotna@email.cz\n \n\r\n If you have questions about this notification, please contact 4G Clinical Support at \n\r\n https://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..d9b5b0b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_been_assigned_medication_for_visit_Open_Label_Induction_Visit_1.6_at_site_S10-CZ10004.pdf differ diff --git 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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..27ea116 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-12_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ 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.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.json new file mode 100644 index 0000000..7b298b8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 15010, + "title": "Discontinue", + "label": "Janssen 42847922MDD3003 Subject CZ100110002 has been discontinued from IRT managed treatment at site S10-CZ10011", + "event": "uv_discontinue", + "actual_date": "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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..973179b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-01-16_Janssen_42847922MDD3003_Subject_CZ100110002_has_been_discontinued_from_IRT_managed_treatment_at_site_S10-CZ10011.pdf differ diff --git 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 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.pdf 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.pdf new file mode 100644 index 0000000..d75cfde Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..cfbb9a5 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16368, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at 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 0000000..725e1c6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..9c92768 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 16369, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has 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 0000000..fc517f0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ 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.json 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 new file mode 100644 index 0000000..90d33c1 --- /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 0000000..19c8e74 Binary files /dev/null and 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 differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.json new file mode 100644 index 0000000..056484b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 17495, + "title": "Screening", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has been screened at site S10-CZ10004", + "event": "Screen", + "actual_date": "2026-02-27", + "subject": "CZ100040007", + "study": "42847922MDD3003", + "text": "42847922MDD3003\nJanssen Pharmaceuticalshttps://janssen.4gclinical.com\nSubject CZ100040007 has been screened.\n \nSite Details \nLocation: CZE \nSite: S10-CZ10004 \nInvestigator: Herman, Erik \n\n \nSubject Details \nSubject: CZ100040007 \nIRT Subject Status: Screened \nCohort: Part 1\nInformed Consent Date at Screening: 27-Feb-2026 \n\nDate of Screening in IRT: 27-Feb-2026 \nTransaction Date/Time (site local): 27-Feb-2026 07:20:02\nTransaction Date/Time (system local): 27-Feb-2026 06:20:02\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/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..23ab149 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-02-27_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_screened_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..9905564 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 17587, + "title": "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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..dafa5e9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..b28793f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 17588, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-03-02", + "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: 1212250\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg\nReturned: 1\n\nMedication ID: 1272090\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): 02-Mar-2026 08:33:15 \nTransaction Date/Time (system local): 02-Mar-2026 07:33:15 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..230f54e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.json new file mode 100644 index 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 0000000..235b6d0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-02_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screened_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..f2c96e8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 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 0000000..5ac193c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-06_Janssen_42847922MDD3003_Subject_CZ100040002_randomized_into_Part_2_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..6516a6d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 18035, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-03-09", + "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: 1021590\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1082155\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1099967\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1111676\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 06-Mar-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 09-Mar-2026 11:30:45\n\nTransaction Date/Time (system local): 09-Mar-2026 10:30:45 \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/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..fbbf7b2 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d42af25 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 18036, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-03-09", + "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: 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..b4d6d39 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-09_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.json new file mode 100644 index 0000000..b2aa8b7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.json @@ -0,0 +1,10 @@ +{ + "pk": 18926, + "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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.pdf new file mode 100644 index 0000000..94452b4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-20_Janssen_42847922MDD3003_Subject_CZ100110011_has_been_screen_failed_at_site_S10-CZ10011.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.json new file mode 100644 index 0000000..f52a694 --- /dev/null +++ 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 \n\nTransaction Date/Time (site local): 25-Mar-2026 08:41:11\nTransaction Date/Time (system local): 25-Mar-2026 07:41:11\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/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..fb262fc Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-25_Janssen_42847922MDD3003_Subject_CZ100040007_randomized_into_Part_1_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..82711a1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 19381, + "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: 1033019\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\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 b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..61da64f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.json new file mode 100644 index 0000000..a97c30f --- /dev/null +++ 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.pdf new file mode 100644 index 0000000..25ab357 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-03-30_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk22022.pdf differ 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 \nhttps://support.4gclinical.com" +} \ No newline at end of file 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.pdf 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.pdf new file mode 100644 index 0000000..e0e6d12 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json new file mode 100644 index 0000000..77be75c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20191, + "title": "Assignment", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has been assigned medication for visit Double Blind Part 1 Visit 6 at site S10-CZ10004", + "event": "DB_P1_V6", + "actual_date": "2026-04-09", + "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 6:\n\nMedication NoMedication TypePackaged Lot NoExpiration Date1008773Seltorexant 20mg or placeboT38650424-Jun-20281171044Seltorexant 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): 09-Apr-2026 15:48:10 \nTransaction Date/Time (system local): 09-Apr-2026 13:48:10 \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/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..c2821fc Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-09_Janssen_42847922MDD3003_Subject_CZ100040007_has_been_assigned_medication_for_visit_Double_Blind_Part_1_Visit_6_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..171c90b --- /dev/null +++ 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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..55993c5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..9430f38 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20363, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-04-13", + "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: 1111676\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 0\n\nMedication ID: 1099967\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 2\n\nMedication ID: 1082155\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1021590\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): 13-Apr-2026 12:53:23 \nTransaction Date/Time (system local): 13-Apr-2026 10:53:23 \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/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..84456c0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git 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 \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..dcbd492 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git 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 at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.pdf new file mode 100644 index 0000000..b321fe9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_dispensing_confirmation_has_occurred_at_site_S10-CZ10004_pk23216.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..924a43c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 20352, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-04-13", + "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: 1033019\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1155666\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 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): 13-Apr-2026 12:03:22 \nTransaction Date/Time (system local): 13-Apr-2026 10:03:22 \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/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..fc29680 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.json new file mode 100644 index 0000000..30c31ff --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.json @@ -0,0 +1,10 @@ +{ + "pk": 22023, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-04-13", + "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: 1070066\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 1\n\nMedication ID: 1108216\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 6\n\nMedication ID: 1008773\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 4\n\nMedication ID: 1171044\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: CZ100040007 \nIRT Subject Status: Enrolled Open Label \n\nTransaction Date/Time (site local): 06-May-2026 08:35:42 \nTransaction Date/Time (system local): 06-May-2026 06:35:42 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at \nhttps://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.pdf new file mode 100644 index 0000000..cc4d5fb Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-13_Janssen_42847922MDD3003_Subject_CZ100040007_has_returned_a_medication_at_site_S10-CZ10004_pk22023.pdf differ 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.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json new file mode 100644 index 0000000..e465d27 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-04-22_Janssen_42847922MDD3003_Subject_CZ100040007_Rolled_Over_from_Part_1_into_Part_2_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 21071, + "title": "Rollover_Part_2", + "label": "Janssen 42847922MDD3003 Subject CZ100040007 Rolled Over from Part 1 into Part 2 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 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 b/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 new file mode 100644 index 0000000..ca95611 Binary files /dev/null and b/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 differ diff --git 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 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.pdf 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.pdf new file mode 100644 index 0000000..f5c8d36 Binary files /dev/null and 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.pdf differ 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.json 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 new file mode 100644 index 0000000..d965cca --- /dev/null +++ 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 index 0000000..43f1400 Binary files /dev/null and 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 differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-04 42847922MDD3003 CZ100040001 Subject Detail.xlsx 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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.json 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 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b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json new file mode 100644 index 0000000..be2ac01 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 22016, + "title": "Dispensation", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 dispensing confirmation has occurred at site S10-CZ10004", + "event": "uv_disp_conf", + "actual_date": "2026-05-06", + "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: 1086477\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1095125\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1140830\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nMedication No: 1171766\n\nProduct Label Type: Seltorexant 20mg or placebo\nMedication status:\n Dispensed\nDispensation date: 28-Apr-2026\nNote (only collected if Not Dispensed):\n \n\nSite Details \nLocation: CZE \nSite:\nS10-CZ10004 \nInvestigator: Herman, Erik \n\nSubject Details \nSubject:\nCZ100040002 \nIRT Subject Status: Randomized Part 2 \n\nTransaction Date/Time (site local): 06-May-2026 07:47:14\n\nTransaction Date/Time (system local): 06-May-2026 05:47:14 \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/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..f92f496 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json new file mode 100644 index 0000000..d05949b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-05-06_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.json @@ -0,0 +1,10 @@ +{ + "pk": 22017, + "title": "Medication_Return", + "label": "Janssen 42847922MDD3003 Subject CZ100040002 has returned a medication at site S10-CZ10004", + "event": "uv_return", + "actual_date": "2026-05-06", + "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: 1079547\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 6\n\nMedication ID: 1061229\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1054757\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 3\n\nMedication ID: 1035027\nMedication status: Returned by Subject\nProduct Label Type: Seltorexant 20mg or placebo\nReturned: 7\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-May-2026 07:48:24 \nTransaction Date/Time (system local): 06-May-2026 05:48:24 \nTransaction performed by: veronika@brezinova.cz\n \nIf you have questions about this notification, please contact 4G Clinical Support at 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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.json 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 new file mode 100644 index 0000000..7d52331 --- /dev/null +++ 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 index 0000000..8eac314 Binary files /dev/null and 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 differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.json 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 0000000..78e5c75 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_dispensing_confirmation_has_occurred_at_site_S10-CZ10004.pdf differ diff --git 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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 a/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf new file mode 100644 index 0000000..6336e44 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/42847922MDD3003/Zpracováno/2026-06-01_Janssen_42847922MDD3003_Subject_CZ100040002_has_returned_a_medication_at_site_S10-CZ10004.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/2026-06-01 77242113UCO3001 CZ100012001 Subject Detail.xlsx b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/2026-06-01 77242113UCO3001 CZ100012001 Subject Detail.xlsx new file mode 100644 index 0000000..e9f5c4e Binary files 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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 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/2026-01-15_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-22_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_created_in_IRT_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 403, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 has been created in IRT at site DD5-CZ10001", + "event": "Create", + "actual_date": "2026-01-22", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 22-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: 22-Jan-2026\n\nTransaction Date/Time (site local): 22-Jan-2026 07:43:26\n\nTransaction Date/Time (system local): 22-Jan-2026 06:43:26\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/2026-01-22_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-22_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..a17f52f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-22_Janssen_77242113UCO3001_Subject_CZ100012001_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..6aec761 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 420, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100222002 has been created in IRT at site DD5-CZ10022", + "event": "Create", + "actual_date": "2026-01-23", + "subject": "CZ100222002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..fd71433 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-01-23_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..72f817e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 752, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100062001 has been created in IRT at site DD5-CZ10006", + "event": "Create", + "actual_date": "2026-02-13", + "subject": "CZ100062001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 13-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: No\n\nDate of Subject Creation in IRT: 13-Feb-2026\n\nTransaction Date/Time (site local): 13-Feb-2026 06:43:53\n\nTransaction Date/Time (system local): 13-Feb-2026 05:43:53\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/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf new file mode 100644 index 0000000..6716f01 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-13_Janssen_77242113UCO3001_Subject_CZ100062001_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..84adbd1 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 861, + "title": "Screenfail", + "label": "Janssen 77242113UCO3001 Subject CZ100222002 has been screen failed at site DD5-CZ10022", + "event": "uv_screen_fail", + "actual_date": "2026-02-19", + "subject": "CZ100222002", + "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: CZ100222002\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 19-Feb-2026\n\nTransaction Date/Time (site local): 19-Feb-2026 15:39:37\n\nTransaction Date/Time (system local): 19-Feb-2026 14:39:37\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/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..9771724 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_CZ100222002_has_been_screen_failed_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.json new 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 0000000..6bf314a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-19_Janssen_77242113UCO3001_Subject_randomized_CZ100012001_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..8a78b66 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1090, + "title": "Screenfail", + "label": "Janssen 77242113UCO3001 Subject CZ100222001 has been screen failed at site DD5-CZ10022", + "event": "uv_screen_fail", + "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 b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..7bbc00e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-20_Janssen_77242113UCO3001_Subject_CZ100222001_has_been_screen_failed_at_site_DD5-CZ10022.pdf differ diff --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 b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..211a1a8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_created_in_IRT_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.json new file mode 100644 index 0000000..49af1bc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 971, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100212001 has been created in IRT at site DD5-CZ10021", + "event": "Create", + "actual_date": "2026-02-25", + "subject": "CZ100212001", + "study": "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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.pdf new file mode 100644 index 0000000..efa7929 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-25_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_created_in_IRT_at_site_DD5-CZ10021.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..809ad7c --- /dev/null +++ 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 Subject Creation in IRT: 26-Feb-2026\n\nTransaction Date/Time (site local): 26-Feb-2026 13:09:10\n\nTransaction Date/Time (system local): 26-Feb-2026 12:09:10\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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..6bf038f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-02-26_Janssen_77242113UCO3001_Subject_CZ100132001_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..797f930 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1054, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 has been created in IRT at site DD5-CZ10022", + "event": "Create", + "actual_date": "2026-03-02", + "subject": "CZ100222003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Screened\n\nRescreened Subject: Yes\n\n Prior Subject : CZ100222002\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 02-Mar-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: 02-Mar-2026\n\nTransaction Date/Time (site local): 02-Mar-2026 10:10:20\n\nTransaction Date/Time (system local): 02-Mar-2026 09:10:20\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/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..e10dfb6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-02_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..17377c0 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1103, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100222004 has been created in IRT at site DD5-CZ10022", + "event": "Create", + "actual_date": "2026-03-03", + "subject": "CZ100222004", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222004 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222004\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 03-Mar-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: 03-Mar-2026\n\nTransaction Date/Time (site local): 03-Mar-2026 11:02:56\n\nTransaction Date/Time (system local): 03-Mar-2026 10:02:56\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/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..77cb887 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-03_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..1aca1cf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1147, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100222005 has been created in IRT at site DD5-CZ10022", + "event": "Create", + "actual_date": "2026-03-04", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222005 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 04-Mar-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: 04-Mar-2026\n\nTransaction Date/Time (site local): 04-Mar-2026 08:11:16\n\nTransaction Date/Time (system local): 04-Mar-2026 07:11:16\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/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..dbb9bd1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-04_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_created_in_IRT_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..408b94f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1266, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 dispensing confirmation has occurred 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" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..3a4a7fd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..b4a0060 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1265, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100222003 at site DD5-CZ10022", + "event": "I0", + "actual_date": "2026-03-09", + "subject": "CZ100222003", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 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 1168110\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: CZ100222003\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-Mar-2026 08:55:24\n\nTransaction Date/Time (system local): 09-Mar-2026 07:55:24\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/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..137d5d4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222003_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.json new file mode 100644 index 0000000..50c0ef4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 1334, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100122001 has been created in IRT at site DD5-CZ10012", + "event": "Create", + "actual_date": "2026-03-10", + "subject": "CZ100122001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100122001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 10-Mar-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: 10-Mar-2026\n\nTransaction Date/Time (site local): 10-Mar-2026 14:15:44\n\nTransaction Date/Time (system local): 10-Mar-2026 13:15:44\n\nTransaction performed by: hosova.kristyna@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/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.pdf new file mode 100644 index 0000000..1e89494 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-10_Janssen_77242113UCO3001_Subject_CZ100122001_has_been_created_in_IRT_at_site_DD5-CZ10012.pdf differ 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..318ed67 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-16_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json 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 b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..8b1703f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk1557.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk1557.json new file mode 100644 index 0000000..314d298 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk1557.json @@ -0,0 +1,10 @@ +{ + "pk": 1557, + "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: 1068485\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 18-Mar-2026\n\n Medication id: 1171236\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 18-Mar-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 09:52:54\n\nTransaction Date/Time (system local): 18-Mar-2026 08:52:54\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_pk1557.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk1557.pdf new file mode 100644 index 0000000..32d21a9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk1557.pdf differ 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.json 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 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.pdf new file mode 100644 index 0000000..f935826 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..4c9925a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 1549, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 has returned a medication at site DD5-CZ10001", + "event": "uv_return", + "actual_date": "2026-03-18", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100012001 has been performed.\n\n \n\n Medication id: 1136793\n Medication status: Returned by Subject\n\nReturned Inner Qty: 0\n Returned Date: 18-Mar-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: 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 Transaction Date/Time (site local): 18-Mar-2026 07:27:02\n\n Transaction Date/Time (system local): 18-Mar-2026 06:27:02\n\n Transaction performed by: matesfalc@seznam.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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..0748be4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-18_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..0e59324 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 1618, + "title": "Dispensation_Confirmation", + "label": "Janssen 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, please contact 4G Clinical Support at http://support.4gclinical.com" +} \ No newline at end of file diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf new file mode 100644 index 0000000..366174c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..616454e --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 1605, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100062001 at site DD5-CZ10006", + "event": "I0", + "actual_date": "2026-03-20", + "subject": "CZ100062001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 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 1058454\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \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\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): 20-Mar-2026 07:35:02\n\nTransaction Date/Time (system local): 20-Mar-2026 06:35:02\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/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.pdf new file mode 100644 index 0000000..f4c2cb6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-20_Janssen_77242113UCO3001_Subject_randomized_CZ100062001_at_site_DD5-CZ10006.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..19b58b9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 1666, + "title": "Screenfail", + "label": "Janssen 77242113UCO3001 Subject CZ100222004 has been screen failed at site DD5-CZ10022", + "event": "uv_screen_fail", + "actual_date": "2026-03-24", + "subject": "CZ100222004", + "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: CZ100222004\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 24-Mar-2026\n\nTransaction Date/Time (site local): 24-Mar-2026 10:23:59\n\nTransaction Date/Time (system local): 24-Mar-2026 09:23:59\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/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..368e2d6 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_CZ100222004_has_been_screen_failed_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..4e09e51 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 1659, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100132001 at site DD5-CZ10013", + "event": "I0", + "actual_date": "2026-03-24", + "subject": "CZ100132001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 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 1086141\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \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\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): 24-Mar-2026 08:09:58\n\nTransaction Date/Time (system local): 24-Mar-2026 07:09:58\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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..5d861c0 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-24_Janssen_77242113UCO3001_Subject_randomized_CZ100132001_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.json 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 b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..7b1c555 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-30_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.json new file mode 100644 index 0000000..030a81b --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.json @@ -0,0 +1,10 @@ +{ + "pk": 1884, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100092001 has been created in IRT at site DD5-CZ10009", + "event": "Create", + "actual_date": "2026-03-31", + "subject": "CZ100092001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100092001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 31-Mar-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: 31-Mar-2026\n\nTransaction Date/Time (site local): 31-Mar-2026 08:39:04\n\nTransaction Date/Time (system local): 31-Mar-2026 06:39:04\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/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf new file mode 100644 index 0000000..129771d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-03-31_Janssen_77242113UCO3001_Subject_CZ100092001_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..7144eb8 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 1953, + "title": "Subject_Number_Creation", + "label": "Janssen 77242113UCO3001 Subject CZ100132002 has been created in IRT at site DD5-CZ10013", + "event": "Create", + "actual_date": "2026-04-01", + "subject": "CZ100132002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..b2d7411 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-01_Janssen_77242113UCO3001_Subject_CZ100132002_has_been_created_in_IRT_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json new file mode 100644 index 0000000..cd89db7 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json @@ -0,0 +1,10 @@ +{ + "pk": 2139, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100122001 dispensing confirmation has 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 0000000..9983596 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.json new file mode 100644 index 0000000..b341323 --- /dev/null +++ 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 0000000..7c41cf1 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100122001_at_site_DD5-CZ10012.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.json new file mode 100644 index 0000000..22e703d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 2110, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100212001 at site DD5-CZ10021", + "event": "I0", + "actual_date": "2026-04-07", + "subject": "CZ100212001", + "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 0000000..d32ace8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-07_Janssen_77242113UCO3001_Subject_randomized_CZ100212001_at_site_DD5-CZ10021.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..bbf58a4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 2165, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100012002 dispensing confirmation has occurred at site DD5-CZ10001", + "event": "uv_disp_conf", + "actual_date": "2026-04-08", + "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: 1185466\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-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): 08-Apr-2026 07:35:25\n\nTransaction Date/Time (system local): 08-Apr-2026 05:35:25\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/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..a57434e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..104a82a --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 2169, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 dispensing confirmation has occurred at site DD5-CZ10022", + "event": "uv_disp_conf", + "actual_date": "2026-04-08", + "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: 1072571\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-2026\n\n Medication id: 1086416\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-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): 08-Apr-2026 08:06:31\n\nTransaction Date/Time (system local): 08-Apr-2026 06:06:31\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/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..3631d2d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..7ba943f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 2167, + "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 08:02:11\n\nTransaction Date/Time (system local): 08-Apr-2026 06:02:11\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/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..d489ed8 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..6971d4c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 2168, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 has returned a medication at site 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..704a36f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf differ diff --git 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..36a29d9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-08_Janssen_77242113UCO3001_Subject_randomized_CZ100012002_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.json new file mode 100644 index 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 0000000..02b7a95 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-09_Janssen_77242113UCO3001_Subject_randomized_CZ100222005_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.json new file mode 100644 index 0000000..8b91eda --- /dev/null +++ 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 Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 13-Apr-2026\n\nTransaction Date/Time (site local): 13-Apr-2026 11:58:29\n\nTransaction Date/Time (system local): 13-Apr-2026 09:58:29\n\nTransaction performed by: zuzana.zahradnikova@ftn.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/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.pdf new file mode 100644 index 0000000..920e55e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-13_Janssen_77242113UCO3001_Subject_CZ100201001_has_been_created_in_IRT_at_site_DD5-CZ10020.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json new file mode 100644 index 0000000..e4d6c93 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 2387, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100212001 dispensing confirmation has occurred at site DD5-CZ10021", + "event": "uv_disp_conf", + "actual_date": "2026-04-14", + "subject": "CZ100212001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100212001 has been performed for the following medication IDs:\n\n Medication id: 1075956\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-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\nTransaction Date/Time (site local): 14-Apr-2026 11:54:08\n\nTransaction Date/Time (system local): 14-Apr-2026 09:54:08\n\nTransaction performed by: dvorakova.zdenka@nemcb.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/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.pdf new file mode 100644 index 0000000..734977f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-14_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json new file mode 100644 index 0000000..157ee33 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 2478, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100062001 dispensing confirmation has occurred at site DD5-CZ10006", + "event": "uv_disp_conf", + "actual_date": "2026-04-15", + "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: 1009513\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 15-Apr-2026\n\n Medication id: 1194467\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 15-Apr-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): 15-Apr-2026 22:07:00\n\nTransaction Date/Time (system local): 15-Apr-2026 20:07:00\n\nTransaction performed by: konecnymi@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/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf new file mode 100644 index 0000000..d172fe9 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-15_Janssen_77242113UCO3001_Subject_CZ100062001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10006.pdf differ 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.json 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 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.pdf new file mode 100644 index 0000000..ec0c179 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.json new file mode 100644 index 0000000..efc58b9 --- /dev/null +++ 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 Subject Creation in IRT: 16-Apr-2026\n\nTransaction Date/Time (site local): 16-Apr-2026 11:13:20\n\nTransaction Date/Time (system local): 16-Apr-2026 09:13:20\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/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf new file mode 100644 index 0000000..cafa33b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-16_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_created_in_IRT_at_site_DD5-CZ10009.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.json 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 index 0000000..68a698d Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-20_Janssen_77242113UCO3001_Subject_CZ100062002_has_been_created_in_IRT_at_site_DD5-CZ10006.pdf differ diff --git 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..d16d32a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100132001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10013.pdf differ 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 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.pdf 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.pdf new file mode 100644 index 0000000..7717798 Binary files /dev/null and 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.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.json new file mode 100644 index 0000000..8c93ac4 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.json @@ -0,0 +1,10 @@ +{ + "pk": 2627, + "title": "Subject_Number_Creation", + "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 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_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.pdf new file mode 100644 index 0000000..725db8c Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100162001_has_been_created_in_IRT_at_site_DD5-CZ10016.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..4732388 --- /dev/null +++ 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 0000000..a48a500 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-21_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf differ diff --git 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) for Subject CZ100132001 has been performed.\n\n \n\n Medication id: 1086141\n Medication status: Returned by Subject\n\nReturned Inner Qty: 3\n Returned Date: 21-Apr-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: 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\n Transaction Date/Time (site local): 24-Apr-2026 10:55:03\n\n Transaction Date/Time (system local): 24-Apr-2026 08:55:03\n\n Transaction performed by: studycoordinator@vnbrno.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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..15d6d22 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-24_Janssen_77242113UCO3001_Subject_CZ100132001_has_returned_a_medication_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-04-29_Janssen_77242113UCO3001_Subject_CZ100012003_has_been_created_in_IRT_at_site_DD5-CZ10001.json 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 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b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 3174, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100212001 has been assigned medication for visit Week I-4 at site DD5-CZ10021", + "event": "I4", + "actual_date": "2026-05-05", + "subject": "CZ100212001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100212001 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 1113012\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1140951\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\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\nTransaction Date/Time (site local): 05-May-2026 10:08:01\n\nTransaction Date/Time (system local): 05-May-2026 08:08:01\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/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10021.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10021.pdf new file mode 100644 index 0000000..ecbbcfd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10021.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.json new file mode 100644 index 0000000..fbf73bf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 3176, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100212001 has returned a 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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.pdf new file mode 100644 index 0000000..56ae63a Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100212001_has_returned_a_medication_at_site_DD5-CZ10021.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json new file mode 100644 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 0000000..5e9d755 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..e0d986f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 3155, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100222005 has been assigned medication for visit Week I-4 at site DD5-CZ10022", + "event": "I4", + "actual_date": "2026-05-05", + "subject": "CZ100222005", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222005 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 1006427\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1198359\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: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 05-May-2026 07:29:40\n\nTransaction Date/Time (system local): 05-May-2026 05:29:40\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/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..3a35978 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.json new 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 (18 years or older)\n\n Transaction Date/Time (site local): 05-May-2026 07:30:26\n\n Transaction Date/Time (system local): 05-May-2026 05:30:26\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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..72bb54b Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_CZ100222005_has_returned_a_medication_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_randomized_CZ100092001_at_site_DD5-CZ10009.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_randomized_CZ100092001_at_site_DD5-CZ10009.json new file mode 100644 index 0000000..7960dc9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_randomized_CZ100092001_at_site_DD5-CZ10009.json @@ -0,0 +1,10 @@ +{ + "pk": 3178, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100092001 at site DD5-CZ10009", + "event": "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 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_randomized_CZ100092001_at_site_DD5-CZ10009.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_randomized_CZ100092001_at_site_DD5-CZ10009.pdf new file mode 100644 index 0000000..49e1f3f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-05_Janssen_77242113UCO3001_Subject_randomized_CZ100092001_at_site_DD5-CZ10009.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..a38f22f --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 3219, + "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: 1094427\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 08:13:27\n\nTransaction Date/Time (system local): 06-May-2026 06:13:27\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.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..b2d4b95 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.json 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 b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.pdf new file mode 100644 index 0000000..6dec51e Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001_pk3240.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..a883e92 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 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 08:00:53\n\nTransaction Date/Time (system local): 06-May-2026 06:00:53\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/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..dbfb7d5 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-06_Janssen_77242113UCO3001_Subject_CZ100012002_has_been_assigned_medication_for_visit_Week_I-4_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.json new file mode 100644 index 0000000..e12de0e --- /dev/null +++ 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 0000000..643ac88 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100122001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10012.pdf differ 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.json 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.json new file mode 100644 index 0000000..1ec37e8 --- /dev/null +++ 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.json @@ -0,0 +1,10 @@ +{ + "pk": 3297, + "title": "Assignment", + "label": "Janssen 77242113UCO3001 Subject CZ100122001 has been assigned medication for visit Week I-4 at site DD5-CZ10012", + "event": "I4", + "actual_date": "2026-05-07", + "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 0000000..02bede3 Binary files /dev/null and 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 differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json new file mode 100644 index 0000000..f6369cc --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-07_Janssen_77242113UCO3001_Subject_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.json @@ -0,0 +1,10 @@ +{ + "pk": 3285, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100212001 dispensing confirmation has occurred at site DD5-CZ10021", + "event": "uv_disp_conf", + "actual_date": "2026-05-07", + "subject": "CZ100212001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100212001 has been performed for the following medication IDs:\n\n Medication id: 1113012\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 05-May-2026\n\n Medication id: 1140951\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-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\nTransaction Date/Time (site local): 07-May-2026 10:17:15\n\nTransaction Date/Time (system local): 07-May-2026 08:17:15\n\nTransaction performed by: dvorakova.zdenka@nemcb.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_CZ100212001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10021.pdf 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a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.json new file mode 100644 index 0000000..1dcfcdf --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.json @@ -0,0 +1,10 @@ +{ + "pk": 3462, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100132002 at site DD5-CZ10013", + "event": "I0", + "actual_date": "2026-05-12", + "subject": "CZ100132002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132002 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 1121604\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132002\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): 12-May-2026 09:37:15\n\nTransaction Date/Time (system local): 12-May-2026 07:37:15\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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.pdf new file mode 100644 index 0000000..99966ea Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-12_Janssen_77242113UCO3001_Subject_randomized_CZ100132002_at_site_DD5-CZ10013.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..f0237de --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 3513, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001", + "event": "uv_disp_conf", + "actual_date": "2026-05-13", + "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: 1168586\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 13-May-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): 13-May-2026 08:26:00\n\nTransaction Date/Time (system local): 13-May-2026 06:26:00\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/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-13_Janssen_77242113UCO3001_Subject_CZ100012001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..616ea7e Binary files /dev/null and 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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 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a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-15_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_screen_failed_at_site_DD5-CZ10009.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-15_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_screen_failed_at_site_DD5-CZ10009.json new file mode 100644 index 0000000..616cdc9 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-15_Janssen_77242113UCO3001_Subject_CZ100092002_has_been_screen_failed_at_site_DD5-CZ10009.json @@ -0,0 +1,10 @@ +{ + "pk": 3656, + "title": "Screenfail", + "label": "Janssen 77242113UCO3001 Subject CZ100092002 has been screen failed at site DD5-CZ10009", + "event": "uv_screen_fail", + "actual_date": "2026-05-15", + "subject": "CZ100092002", + "study": "77242113UCO3001", + "text": "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 0000000..4debac4 Binary files /dev/null and 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DD5-CZ10013", + "event": "uv_disp_conf", + "actual_date": "2026-05-18", + "subject": "CZ100132002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100132002 has been performed for the following medication IDs:\n\n Medication id: 1121604\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 12-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-May-2026 08:47:46\n\nTransaction Date/Time (system local): 18-May-2026 06:47:46\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 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CZE\n\nSite: DD5-CZ10020\n\nInvestigator: Lucie Gonsorcikova\n\nSubject Details\n\nSubject: CZ100201001\n\nIRT Subject Status: Enrolled\n\nCohort: Adolescent subjects (under 18 years)\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): 18-May-2026 09:32:37\n\nTransaction Date/Time (system local): 18-May-2026 07:32:37\n\nTransaction performed by: zuzana.zahradnikova@ftn.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/2026-05-18_Janssen_77242113UCO3001_Subject_enrolled_CZ100201001_at_site_DD5-CZ10020.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-18_Janssen_77242113UCO3001_Subject_enrolled_CZ100201001_at_site_DD5-CZ10020.pdf new file mode 100644 index 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"actual_date": "2026-05-26", + "subject": "CZ100062002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100062002 has been performed for the following medication IDs:\n\n Medication id: 1114467\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 26-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 26-May-2026 17:51:04\n\nTransaction Date/Time (system local): 26-May-2026 15:51:04\n\nTransaction performed by: konecnymi@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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index 0000000..7d43648 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-26_Janssen_77242113UCO3001_Subject_randomized_CZ100062002_at_site_DD5-CZ10006.json @@ -0,0 +1,10 @@ +{ + "pk": 4083, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100062002 at site DD5-CZ10006", + "event": "I0", + "actual_date": "2026-05-26", + "subject": "CZ100062002", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062002 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 1114467\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062002\n\nIRT Subject Status: Randomized\n\nCohort: Adult 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Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012003 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 1150102\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: CZ100012003\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): 27-May-2026 07:25:31\n\nTransaction Date/Time (system local): 27-May-2026 05:25:31\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/2026-05-27_Janssen_77242113UCO3001_Subject_randomized_CZ100012003_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-27_Janssen_77242113UCO3001_Subject_randomized_CZ100012003_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..e284159 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-27_Janssen_77242113UCO3001_Subject_randomized_CZ100012003_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json new file mode 100644 index 0000000..cb7351d --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.json @@ -0,0 +1,10 @@ +{ + "pk": 4311, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100012001 has returned a medication at site DD5-CZ10001", + "event": "uv_return", + "actual_date": "2026-05-28", + "subject": "CZ100012001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100012001 has been performed.\n\n \n\n Medication id: 1068485\n Medication status: Returned by Subject\n\nReturned Inner Qty: 0\n Returned Date: 13-May-2026\n Medication id: 1171236\n Medication status: Returned by Subject\n\nReturned Inner Qty: 12\n Returned Date: 13-May-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: 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 Transaction Date/Time (site local): 28-May-2026 14:40:19\n\n Transaction Date/Time (system local): 28-May-2026 12:40:19\n\n Transaction performed by: matesfalc@seznam.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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf new file mode 100644 index 0000000..b668650 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100012001_has_returned_a_medication_at_site_DD5-CZ10001.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.json new file mode 100644 index 0000000..ec34820 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.json @@ -0,0 +1,10 @@ +{ + "pk": 4298, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100162001 dispensing confirmation has occurred at site DD5-CZ10016", + "event": "uv_disp_conf", + "actual_date": "2026-05-28", + "subject": "CZ100162001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100162001 has been performed for the following medication IDs:\n\n Medication id: 1129216\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 28-May-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10016\n\nInvestigator: Robert Mudr\n\nSubject Details\n\nSubject: CZ100162001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 28-May-2026 11:15:42\n\nTransaction Date/Time (system local): 28-May-2026 09:15:42\n\nTransaction performed by: magdalena.kubasiakova@nmskb.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/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.pdf new file mode 100644 index 0000000..f7c160f Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_CZ100162001_dispensing_confirmation_has_occurred_at_site_DD5-CZ10016.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.json new file mode 100644 index 0000000..ab8e1da --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.json @@ -0,0 +1,10 @@ +{ + "pk": 4296, + "title": "Randomized", + "label": "Janssen 77242113UCO3001 Subject randomized CZ100162001 at site DD5-CZ10016", + "event": "I0", + "actual_date": "2026-05-28", + "subject": "CZ100162001", + "study": "77242113UCO3001", + "text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100162001 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 1129216\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10016\n\nInvestigator: Robert Mudr\n\nSubject Details\n\nSubject: CZ100162001\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): 28-May-2026 10:42:58\n\nTransaction Date/Time (system local): 28-May-2026 08:42:58\n\nTransaction performed by: petr.pekny@nmskb.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/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.pdf new file mode 100644 index 0000000..c8e39dd Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-05-28_Janssen_77242113UCO3001_Subject_randomized_CZ100162001_at_site_DD5-CZ10016.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..66da77c --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 4425, + "title": "Dispensation_Confirmation", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 dispensing confirmation has occurred at site DD5-CZ10022", + "event": "uv_disp_conf", + "actual_date": "2026-06-01", + "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: 1170597\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 01-Jun-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): 01-Jun-2026 14:48:37\n\nTransaction Date/Time (system local): 01-Jun-2026 12:48:37\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/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..27cd8e4 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_dispensing_confirmation_has_occurred_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..48ca714 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 4423, + "title": "Assignment_i12_m0", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 has been assigned medication for visit Week I-12 / M-0 at site DD5-CZ10022", + "event": "M0", + "actual_date": "2026-06-01", + "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-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 1170597\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\nClinical Response at I-12 / M-0: Clinical Non-Responder\n\n Concomitant Use of Corticosteroids: Yes\n\n Clinical Remission: No\n\nTransaction Date/Time (site local): 01-Jun-2026 14:30:19\n\nTransaction Date/Time (system local): 01-Jun-2026 12:30:19\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/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..5779e35 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_been_assigned_medication_for_visit_Week_I-12__M-0_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json new file mode 100644 index 0000000..c4e1d03 --- /dev/null +++ b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.json @@ -0,0 +1,10 @@ +{ + "pk": 4421, + "title": "Medication_Return", + "label": "Janssen 77242113UCO3001 Subject CZ100222003 has returned a medication at site DD5-CZ10022", + "event": "uv_return", + "actual_date": "2026-06-01", + "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: 1072571\n Medication status: Returned by Subject\n\nReturned Inner Qty: 0\n Returned Date: 01-Jun-2026\n Medication id: 1086416\n Medication status: Returned by Subject\n\nReturned Inner Qty: 10\n Returned Date: 01-Jun-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): 01-Jun-2026 13:59:54\n\n Transaction Date/Time (system local): 01-Jun-2026 11:59:54\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 a/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf new file mode 100644 index 0000000..446cb77 Binary files /dev/null and b/IWRS/Patients/IncomingSourceReportsDetails/77242113UCO3001/Zpracováno/2026-06-01_Janssen_77242113UCO3001_Subject_CZ100222003_has_returned_a_medication_at_site_DD5-CZ10022.pdf differ diff --git a/IWRS/Patients/create_iwrs_tables.py b/IWRS/Patients/create_iwrs_tables.py new file mode 100644 index 0000000..1f80b74 --- /dev/null +++ b/IWRS/Patients/create_iwrs_tables.py @@ -0,0 +1,39 @@ +""" +Jednorázový skript — vytvoří/aktualizuje tabulky v MySQL. +Spusť jednou: python create_iwrs_tables.py +""" +import os +import mysql.connector +import db_config + +BASE_DIR = os.path.dirname(os.path.abspath(__file__)) +SQL_FILE = os.path.join(BASE_DIR, "create_iwrs_tables.sql") + +conn = mysql.connector.connect( + host=db_config.DB_HOST, + port=db_config.DB_PORT, + user=db_config.DB_USER, + password=db_config.DB_PASSWORD, + database=db_config.DB_NAME, +) +cursor = conn.cursor() + +sql = open(SQL_FILE, encoding="utf-8").read() +# Odstraň komentáře a rozdělíme na příkazy +stmts = [s.strip() for s in sql.split(";")] +for stmt in stmts: + # Odstraň řádkové komentáře + lines = [l for l in stmt.splitlines() if not l.strip().startswith("--")] + stmt = "\n".join(lines).strip() + if not stmt or stmt.upper().startswith("USE"): + continue + try: + cursor.execute(stmt) + print(f"OK: {stmt[:80]}") + except Exception as e: + print(f"SKIP: {e}") + +conn.commit() +cursor.close() +conn.close() +print("\nHotovo.") diff --git a/IWRS/Patients/download_subject_notifications.py b/IWRS/Patients/download_subject_notifications.py new file mode 100644 index 0000000..029a3e1 --- /dev/null +++ b/IWRS/Patients/download_subject_notifications.py @@ -0,0 +1,201 @@ +from playwright.sync_api import sync_playwright +import os +import glob +import datetime +import requests + +import pandas as pd + +# ── CONFIG ────────────────────────────────────────────────────────────────── +BASE_URL = "https://janssen.4gclinical.com" +EMAIL = "vbuzalka@its.jnj.com" +PASSWORD = "Vlado123++-+" + +STUDIES = ["77242113UCO3001", "42847922MDD3003"] + +BASE_DIR = os.path.dirname(os.path.abspath(__file__)) +INCOMING_DIR = os.path.join(BASE_DIR, "IncomingSourceReports") +DETAILS_DIR = os.path.join(BASE_DIR, "IncomingSourceReportsDetails") +# ──────────────────────────────────────────────────────────────────────────── + + +def get_subjects(study): + pattern = os.path.join(INCOMING_DIR, f"* {study} Subject Summary Report.xlsx") + files = sorted( + [f for f in glob.glob(pattern) if not os.path.basename(f).startswith("~$")], + key=os.path.getmtime, + reverse=True, + ) + if not files: + raise FileNotFoundError(f"Nenalezen Subject Summary Report pro {study}") + today = datetime.date.today().strftime("%Y-%m-%d") + if not os.path.basename(files[0]).startswith(today): + raise FileNotFoundError( + f"Dnešní Subject Summary Report pro {study} neexistuje — spusť nejdříve download_subject_summary.py" + ) + path = files[0] + print(f" Čtu subjekty z: {os.path.basename(path)}") + + raw = pd.read_excel(path, header=None) + header_row = None + for i, row in raw.iterrows(): + if "Subject" in [str(v).strip() for v in row]: + header_row = i + break + if header_row is None: + raise ValueError("Hlavičkový řádek nenalezen") + + df = pd.read_excel(path, header=header_row) + subjects = df["Subject"].dropna().astype(str).str.strip().tolist() + return subjects + + +def get_jwt_and_api_base(page, study): + """Získá JWT token a api_base_url pro danou studii.""" + jwt = page.evaluate("localStorage.getItem('JWT.access')") + if not jwt: + raise ValueError("JWT token nenalezen v localStorage") + + instances = page.evaluate("""async (jwt) => { + const res = await fetch('/_/api/dispatch/app_instances/', { + headers: { 'Authorization': `Bearer ${jwt}` } + }); + return res.json(); + }""", jwt) + + instance = next( + (i for i in instances if study in i.get("label", "")), + None + ) + if not instance: + raise ValueError(f"app_instance pro studii {study} nenalezena") + + return jwt, instance["api_base_url"] + + +def get_notifications(jwt, api_base, study, subject): + """Načte seznam notifikací pro daného subjekta přes report_data API.""" + url = f"{BASE_URL}{api_base}/api/v1/reports_api/report_data" + params = { + "path": "patient_detail_report", + "id": subject, + "key": "table_1", + "unblinded": "false", + } + payload = { + "path": "patient_detail_report", + "study": study, + "id": subject, + "key": "table_1", + "fields": {}, + "filters": [{"tableId": "table_1", "tableFilters": {}}], + "pagination_details": {"order": "type", "reverseOrder": False, "page": 1, "limit": 500}, + "cache_key": f"py_{subject}_{datetime.datetime.now().timestamp()}", + } + headers = { + "Authorization": f"Bearer {jwt}", + "Content-Type": "application/json", + "lang": "en", + } + resp = requests.post(url, params=params, json=payload, headers=headers) + resp.raise_for_status() + data = resp.json() + + notifications = [] + for row in data.get("data", []): + for notif in row.get("notification", []): + item = notif.get("item", {}) + pk = item.get("pk") + title = item.get("et_title") + if pk and title: + notifications.append({"pk": pk, "title": title, "event": row.get("event_event_id", "")}) + return notifications + + +def download_pdf(jwt, api_base, pk, title, out_path): + """Stáhne PDF notifikaci a uloží ji.""" + url = f"{BASE_URL}{api_base}/api/v1/meta_api/pdfnotification" + params = {"pk": pk, "title": title, "html": "true"} + headers = { + "Authorization": f"Bearer {jwt}", + "lang": "en", + "Accept": "*/*", + } + resp = requests.get(url, params=params, headers=headers) + resp.raise_for_status() + with open(out_path, "wb") as f: + f.write(resp.content) + + +def run(page, study): + out_dir = os.path.join(DETAILS_DIR, study) + os.makedirs(out_dir, exist_ok=True) + + subjects = get_subjects(study) + print(f" Nalezeno {len(subjects)} subjektů") + today = datetime.date.today().strftime("%Y-%m-%d") + + # Načteme stránku aby byl platný session kontext + page.goto(f"{BASE_URL}/report/patient_detail_report") + page.wait_for_load_state("networkidle", timeout=120000) + + jwt, api_base = get_jwt_and_api_base(page, study) + print(f" API base: {api_base}") + + for subject in subjects: + print(f" [{subject}] Stahuji notifikace...") + try: + notifications = get_notifications(jwt, api_base, study, subject) + if not notifications: + print(f" [{subject}] Žádné notifikace") + continue + + for notif in notifications: + pk = notif["pk"] + title = notif["title"] + filename = os.path.join(out_dir, f"{today} {study} {subject} Notification {title} pk{pk}.pdf") + if os.path.exists(filename): + print(f" [{subject}] {title} (pk={pk}) — již existuje, přeskakuji") + continue + download_pdf(jwt, api_base, pk, title, filename) + print(f" [{subject}] {title} (pk={pk}) OK") + + except Exception as e: + print(f" [{subject}] CHYBA při notifikacích: {e}") + + print(f" [{study}] Notifikace hotovo.") + + +def main(): + os.makedirs(DETAILS_DIR, exist_ok=True) + + with sync_playwright() as p: + for study in STUDIES: + print(f"\n[{study}] Přihlášení...") + browser = p.chromium.launch(headless=False) + context = browser.new_context(accept_downloads=True) + page = context.new_page() + + page.goto(BASE_URL) + page.wait_for_load_state("networkidle") + page.get_by_label("Email *").fill(EMAIL) + page.get_by_label("Password *").fill(PASSWORD) + page.locator("#login__submit").click() + page.wait_for_load_state("networkidle") + + page.get_by_label("Study *").click() + page.get_by_role("option", name=study).click() + page.get_by_role("button", name="SELECT").click() + page.wait_for_load_state("networkidle") + + try: + run(page, study) + except Exception as e: + print(f" [{study}] CHYBA: {e}") + + browser.close() + + print("\nVše hotovo.") + + +main() diff --git a/IWRS/Patients/test_notifications.py b/IWRS/Patients/test_notifications.py new file mode 100644 index 0000000..ae2c5d3 --- /dev/null +++ b/IWRS/Patients/test_notifications.py @@ -0,0 +1,172 @@ +from playwright.sync_api import sync_playwright +import re +import os +import datetime +import mysql.connector +import db_config + + +def get_existing_pks(study): + """Vrátí set pk notifikací které už jsou v DB pro danou studii.""" + try: + conn = mysql.connector.connect( + host=db_config.DB_HOST, port=db_config.DB_PORT, + user=db_config.DB_USER, password=db_config.DB_PASSWORD, + database=db_config.DB_NAME, + ) + cursor = conn.cursor() + cursor.execute("SELECT pk FROM iwrs_notifications WHERE study = %s", (study,)) + pks = {row[0] for row in cursor.fetchall()} + cursor.close() + conn.close() + return pks + except Exception as e: + print(f" UPOZORNĚNÍ: nelze načíst existující pk z DB ({e}), stahuji vše") + return set() + +BASE_URL = "https://janssen.4gclinical.com" +EMAIL = "vbuzalka@its.jnj.com" +PASSWORD = "Vlado123++-+" + +STUDY = "77242113UCO3001" +SUBJECT = "CZ100222003" + +BASE_DIR = os.path.dirname(os.path.abspath(__file__)) +DETAILS_DIR = os.path.join(BASE_DIR, "IncomingSourceReportsDetails") + + +def strip_html(html): + text = re.sub(r"", "\n", html, flags=re.IGNORECASE) + text = re.sub(r"<[^>]+>", "", text) + text = re.sub(r"\n{3,}", "\n\n", text) + return text.strip() + + +def main(): + existing_pks = get_existing_pks(STUDY) + print(f"V DB již existuje {len(existing_pks)} notifikací pro {STUDY}") + + with sync_playwright() as p: + browser = p.chromium.launch(headless=False, args=["--start-maximized"]) + context = browser.new_context(no_viewport=True) + page = context.new_page() + + print("Přihlašuji se...") + page.goto(BASE_URL) + page.wait_for_load_state("networkidle") + page.get_by_label("Email *").fill(EMAIL) + page.get_by_label("Password *").fill(PASSWORD) + page.locator("#login__submit").click() + page.wait_for_load_state("networkidle") + + page.get_by_label("Study *").click() + page.get_by_role("option", name=STUDY).click() + page.get_by_role("button", name="SELECT").click() + page.wait_for_load_state("networkidle") + + page.goto(f"{BASE_URL}/report/patient_detail_report") + page.wait_for_load_state("networkidle", timeout=60000) + + # JWT + api_base + jwt = page.evaluate("localStorage.getItem('JWT.access')") + print(f"JWT: {jwt[:30]}...") + instances = page.evaluate("""async (jwt) => { + const res = await fetch('/_/api/dispatch/app_instances/', { + headers: { 'Authorization': `Bearer ${jwt}` } + }); + return res.json(); + }""", jwt) + instance = next((i for i in instances if STUDY in i.get("label", "")), None) + if not instance: + raise ValueError(f"Instance pro {STUDY} nenalezena") + api_base = instance["api_base_url"] + print(f"API base: {api_base}") + + # Vyber subjekt a zachyť table_1 response přímo + print(f"Vybírám subjekt {SUBJECT}...") + input_field = page.locator('input[placeholder="search"], input[type="text"]').first + input_field.click() + input_field.fill(SUBJECT) + page.wait_for_timeout(1000) + + captured = {} + with page.expect_response( + lambda r: "report_data" in r.url and "table_1" in r.url, + timeout=60000 + ) as resp_info: + page.locator("mat-option").first.dispatch_event("click") + + response = resp_info.value + data = response.json() + + out_dir = os.path.join(DETAILS_DIR, STUDY) + os.makedirs(out_dir, exist_ok=True) + today = datetime.date.today().strftime("%Y-%m-%d") + + print(f"\n{'='*60}") + print(f"Subjekt: {SUBJECT} | Studie: {STUDY}") + print(f"{'='*60}") + + count = 0 + for row in data.get("data", []): + for notif in (row.get("notification") or []): + item = notif.get("item", {}) + pk = item.get("pk") + title = item.get("et_title") + label = (notif.get("label") or title or "").strip() + # Celý label, mezery → podtržítka, nepovolené znaky pryč + safe_label = re.sub(r'[\\/*?:"<>|]', "", label).replace(" ", "_") + body = item.get("body", "") + text = strip_html(body) + count += 1 + print(f"\n--- Notifikace #{count}: {safe_label} (pk={pk}) | event: {row.get('event_event_id')} ---") + print(text) + + if pk in existing_pks: + print(f" → pk={pk} již v DB, přeskakuji") + continue + + actual_date = row.get("actual_date_raw", "0000-00-00") + pdf_filename = os.path.join(out_dir, f"{actual_date}_{safe_label}.pdf") + if os.path.exists(pdf_filename): + pdf_filename = os.path.join(out_dir, f"{actual_date}_{safe_label}_pk{pk}.pdf") + + pdf_url = f"{BASE_URL}{api_base}/api/v1/meta_api/pdfnotification?pk={pk}&title={title}&html=true" + pdf_resp = page.request.get(pdf_url, headers={ + "Authorization": f"Bearer {jwt}", + "lang": "en", + "prancer_study": STUDY, + "Accept": "application/json, text/plain, */*", + }) + if pdf_resp.ok: + with open(pdf_filename, "wb") as f: + f.write(pdf_resp.body()) + print(f" → PDF uloženo: {os.path.basename(pdf_filename)}") + json_filename = pdf_filename.replace(".pdf", ".json") + import json + with open(json_filename, "w", encoding="utf-8") as f: + json.dump({ + "pk": pk, + "title": title, + "label": label, + "event": row.get("event_event_id"), + "actual_date": actual_date, + "subject": SUBJECT, + "study": STUDY, + "text": text, + }, f, ensure_ascii=False, indent=2) + print(f" → JSON uloženo: {os.path.basename(json_filename)}") + else: + print(f" → PDF chyba: {pdf_resp.status}") + page.wait_for_timeout(300) + + if count == 0: + print("Žádné notifikace nalezeny.") + else: + print(f"\n{'='*60}") + print(f"Celkem notifikací: {count}") + + browser.close() + + +main()