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Site 07 — Hospices Civils de Lyon

FR — Lyon

Principal Investigator

Dr. Isabelle Lefebvre

Enrollment

11 / 15

Last Contact

13 Mar 2026

Status

ACTIVE

Date Direction Category Subject Status Actions
13 Mar 2026 15:45 ← In Complaint Patient Complaint — Discomfort During Catheter Procedure — Subject 07-006 Open Draft Response
07 Feb 2026 09:15 ← In Enrollment Enrollment Update — Subject 07-011 Enrolled Closed Draft Response
08 Jan 2026 10:15 ← In Monitoring Re: Monitoring Visit Scheduling — Site 07 Lyon — Visit 3 Confirmed Closed Draft Response
07 Jan 2026 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 07 Lyon — Visit 3 Closed Draft Response
01 Dec 2025 09:00 ← In Regulatory / Ethics Ethics Committee Approval — Amendment 2 — Site 07 Lyon Closed Draft Response
24 Nov 2025 09:00 ← In Enrollment Enrollment Update — Subject 07-010 Enrolled Closed Draft Response
22 Oct 2025 14:30 ← In Monitoring Re: Monitoring Visit Scheduling — Site 07 Lyon — Visit 2 Confirmed Closed Draft Response
22 Oct 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 07 Lyon — Visit 2 Closed Draft Response
10 Sep 2025 09:30 ← In Enrollment Enrollment Update — Subject 07-009 Enrolled Closed Draft Response
05 Aug 2025 15:00 ← In Monitoring Re: Monitoring Visit Scheduling — Site 07 Lyon — Visit 1 Confirmed Closed Draft Response
05 Aug 2025 09:00 → Out Monitoring Monitoring Visit Scheduling — Site 07 Lyon — Visit 1 Closed Draft Response
23 Jul 2025 10:00 ← In Enrollment Enrollment Update — Subjects 07-006 Through 07-008 Enrolled Closed Draft Response
25 Jun 2025 09:00 ← In Enrollment Enrollment Update — Subjects 07-004 and 07-005 Enrolled Closed Draft Response
27 May 2025 09:15 ← In Enrollment Enrollment Update — Subjects 07-002 and 07-003 Consented Closed Draft Response
09 May 2025 09:00 ← In Enrollment Enrollment Update — Subject 07-001 Screened Successfully Closed Draft Response
28 Apr 2025 09:30 ← In Logistics / Admin Site Initiation Visit Confirmation — Site 07 Lyon Closed Draft Response
SAE ID Type Severity Awareness Date Deadline Status Actions
SAE-002 COMPLAINT Complaint 13 Mar 2026 Open View

Total Communications

16

Open Communications

1

Pending Reviews

1


Communication Breakdown by Category

Category Count
Enrollment 7
Monitoring 6
Complaint 1
Regulatory / Ethics 1
Logistics / Admin 1
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