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Site 04 — Universitätsklinikum Hamburg-Eppendorf

DE — Hamburg

Principal Investigator

Dr. Friedrich Richter

Enrollment

12 / 15

Last Contact

01 Mar 2026

Status

ACTIVE

Date Direction Category Subject Status Actions
01 Mar 2026 09:45 ← In Safety / Vigilance Serious Adverse Event Report — Subject 04-009 — VascuPath 3F Open Draft Response
14 Feb 2026 10:30 ← In CAT-QRY Re: Query Resolution — eCRF Page 18, Subject 04-007 — Documentation Updated Closed Draft Response
12 Feb 2026 09:00 → Out CAT-QRY Query Resolution Request — eCRF Page 18, Subject 04-007 — Inclusion Criteria Doc Closed Draft Response
22 Jan 2026 09:30 ← In Enrollment Enrollment Update — Subject 04-012 Enrolled Closed Draft Response
19 Dec 2025 10:00 ← In Monitoring Re: Monitoring Visit Scheduling — Site 04 Hamburg — Visit 3 Confirmed Closed Draft Response
18 Dec 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 04 Hamburg — Visit 3 Closed Draft Response
18 Nov 2025 10:00 ← In Enrollment Enrollment Update — Subjects 04-009 Through 04-011 Enrolled Closed Draft Response
28 Oct 2025 10:15 ← In Monitoring Re: Monitoring Visit Scheduling — Site 04 Hamburg — Visit 2 Confirmed Closed Draft Response
27 Oct 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 04 Hamburg — Visit 2 Closed Draft Response
22 Sep 2025 09:00 → Out Monitoring Monitoring Visit Report Follow-Up — Site 04 Hamburg — Visit 1 Findings Closed Draft Response
25 Aug 2025 10:30 ← In Enrollment Enrollment Update — Subjects 04-006 Through 04-008 Enrolled Closed Draft Response
28 Jul 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 04 Hamburg — Visit 1 Closed Draft Response
10 Jul 2025 14:30 → Out CAT-SUP Re: Device Supply Request — Shipment Scheduled — Site 04 Closed Draft Response
10 Jul 2025 08:00 ← In CAT-SUP Device Supply Request — Additional VascuPath 3F Units — Site 04 Closed Draft Response
18 Jun 2025 09:30 ← In Enrollment Enrollment Update — Subjects 04-002 Through 04-005 Enrolled Closed Draft Response
22 May 2025 16:30 → Out Protocol Clarification Re: Protocol Clarification Request — Section 6.2 Visit Window Definition Closed Draft Response
22 May 2025 09:30 ← In Protocol Clarification Protocol Clarification Request — Section 6.2 Visit Window Definition Closed Draft Response
05 May 2025 08:30 ← In Enrollment Enrollment Update — Subject 04-001 Screened and Consented Closed Draft Response
23 Apr 2025 09:00 ← In Logistics / Admin Site Initiation Visit Confirmation — Site 04 Hamburg Closed Draft Response
SAE ID Type Severity Awareness Date Deadline Status Actions
SAE-001 SAE Serious 02 Mar 2026 17 Mar 2026 Open View

Total Communications

19

Open Communications

1

Pending Reviews

1


Communication Breakdown by Category

Category Count
Monitoring 6
Enrollment 5
CAT-QRY 2
CAT-SUP 2
Protocol Clarification 2
Safety / Vigilance 1
Logistics / Admin 1
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