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Site 08 — Szpital Kliniczny w Warszawie

PL — Warsaw

Principal Investigator

Dr. Tomasz Kowalski

Enrollment

11 / 15

Last Contact

09 Mar 2026

Status

ACTIVE

Date Direction Category Subject Status Actions
09 Mar 2026 10:00 ← In Monitoring Monitoring Visit Report — Site 08 Warsaw — Visit 3 Complete — No Findings Closed Draft Response
02 Mar 2026 10:00 ← In CAT-QRY Re: Query Resolution — eCRF Page 10, Subject 08-005 — Date Confirmed Closed Draft Response
28 Feb 2026 09:00 → Out CAT-QRY Query Resolution Request — eCRF Page 10, Subject 08-005 — Follow-Up Visit Date C Closed Draft Response
05 Feb 2026 10:00 ← In Enrollment Enrollment Update — Subject 08-011 Enrolled Closed Draft Response
09 Jan 2026 15:30 ← In Monitoring Re: Monitoring Visit Scheduling — Site 08 Warsaw — Visit 3 Confirmed Closed Draft Response
09 Jan 2026 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 08 Warsaw — Visit 3 Closed Draft Response
03 Dec 2025 11:30 → Out Safety / Vigilance Re: Adverse Event Report — Subject 08-007 — Acknowledgement and Assessment Closed Draft Response
03 Dec 2025 08:45 ← In Safety / Vigilance Adverse Event Report — Subject 08-007 — Mild Discomfort During Catheter Insertio Closed Draft Response
07 Nov 2025 09:15 ← In Enrollment Enrollment Update — Subjects 08-009 and 08-010 Enrolled Closed Draft Response
10 Oct 2025 14:00 ← In Monitoring Re: Monitoring Visit Scheduling — Site 08 Warsaw — Visit 2 Confirmed Closed Draft Response
10 Oct 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 08 Warsaw — Visit 2 Closed Draft Response
03 Sep 2025 10:00 ← In Enrollment Enrollment Update — Subjects 08-007 and 08-008 Enrolled Closed Draft Response
31 Jul 2025 09:15 ← In Monitoring Re: Monitoring Visit Scheduling — Site 08 Warsaw — Visit 1 Confirmed Closed Draft Response
30 Jul 2025 10:00 → Out Monitoring Monitoring Visit Scheduling — Site 08 Warsaw — Visit 1 Closed Draft Response
03 Jul 2025 10:30 ← In Enrollment Enrollment Update — Subjects 08-004 Through 08-006 Enrolled Closed Draft Response
04 Jun 2025 14:00 ← In Regulatory / Ethics Ethics Committee Approval — Amendment 1 — Site 08 Warsaw Closed Draft Response
28 May 2025 11:30 ← In Enrollment Enrollment Update — Subjects 08-002 and 08-003 Screened Successfully Closed Draft Response
10 May 2025 10:30 ← In Enrollment Enrollment Update — Subject 08-001 Screened Successfully Closed Draft Response
29 Apr 2025 08:45 ← In Logistics / Admin Site Initiation Visit Confirmation — Site 08 Warsaw Closed Draft Response
SAE ID Type Severity Awareness Date Deadline Status Actions
SAE-005 AE Non-serious 03 Dec 2025 Closed View

Total Communications

19

Open Communications

0

Pending Reviews

0


Communication Breakdown by Category

Category Count
Monitoring 7
Enrollment 6
CAT-QRY 2
Safety / Vigilance 2
Regulatory / Ethics 1
Logistics / Admin 1
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