Site 01 — University Hospital Brussels
BE — Brussels
Principal Investigator
Dr. Elise Van den Berg
Enrollment
14 / 15
Last Contact
12 Mar 2026
Status
ACTIVE
| Date | Direction | Category | Subject | Status | Actions |
|---|---|---|---|---|---|
| 12 Mar 2026 10:15 | ← In | Monitoring | Monitoring Visit Report — Site 01 Brussels — Visit 3 Complete — Minor Findings | Closed | Draft Response |
| 26 Feb 2026 10:00 | ← In | Enrollment | Enrollment Update — Subject 01-014 Enrolled — One Remaining to Target | Closed | Draft Response |
| 04 Feb 2026 09:30 | ← In | CAT-QRY | Re: Query Resolution — eCRF Page 22, Subject 01-008 — Discrepancy Resolved | Closed | Draft Response |
| 02 Feb 2026 10:00 | → Out | CAT-QRY | Query Resolution Request — eCRF Page 22, Subject 01-008 — Device Accountability | Closed | Draft Response |
| 12 Jan 2026 09:00 | ← In | Enrollment | Enrollment Update — Subjects 01-011 Through 01-013 Enrolled | Closed | Draft Response |
| 17 Dec 2025 10:30 | ← In | Monitoring | Re: Monitoring Visit Scheduling — Site 01 Brussels — Visit 3 Confirmed | Closed | Draft Response |
| 16 Dec 2025 09:00 | → Out | Monitoring | Monitoring Visit Scheduling — Site 01 Brussels — Visit 3 | Closed | Draft Response |
| 20 Nov 2025 09:00 | → Out | Regulatory / Ethics | Ethics Committee Approval — Amendment 2 — Site 01 Brussels | Closed | Draft Response |
| 03 Nov 2025 09:00 | ← In | Enrollment | Enrollment Update — Subjects 01-005 Through 01-010 Enrolled | Closed | Draft Response |
| 05 Oct 2025 10:00 | → Out | Safety / Vigilance | Re: Serious Adverse Event Report — Subject 01-005 — Acknowledgement and Regulato | Closed | Draft Response |
| 05 Oct 2025 07:30 | ← In | Safety / Vigilance | Serious Adverse Event Report — Subject 01-005 — Hospitalization After Procedure | Closed | Draft Response |
| 18 Sep 2025 10:00 | ← In | Monitoring | Re: Monitoring Visit Scheduling — Site 01 Brussels — Visit 2 Confirmed | Closed | Draft Response |
| 17 Sep 2025 09:00 | → Out | Monitoring | Monitoring Visit Scheduling — Site 01 Brussels — Visit 2 | Closed | Draft Response |
| 22 Aug 2025 09:15 | ← In | CAT-QRY | Re: Query Resolution — eCRF Page 8, Subject 01-003 — Lab Values Updated | Closed | Draft Response |
| 20 Aug 2025 10:00 | → Out | CAT-QRY | Query Resolution Request — eCRF Page 8, Subject 01-003 — Missing Lab Values | Closed | Draft Response |
| 04 Aug 2025 09:00 | ← In | Monitoring | Monitoring Visit Report — Site 01 Brussels — Visit 1 Complete | Closed | Draft Response |
| 17 Jul 2025 10:30 | ← In | Monitoring | Re: Monitoring Visit Scheduling — Site 01 Brussels — Visit 1 Confirmed | Closed | Draft Response |
| 16 Jul 2025 09:00 | → Out | Monitoring | Monitoring Visit Scheduling — Site 01 Brussels — Visit 1 | Closed | Draft Response |
| 27 Jun 2025 15:00 | → Out | CAT-SUP | Re: Device Supply Request — Shipment Confirmed — Site 01 | Closed | Draft Response |
| 27 Jun 2025 08:30 | ← In | CAT-SUP | Device Supply Request — Additional VascuPath 3F Catheters — Site 01 | Closed | Draft Response |
| 02 Jun 2025 09:00 | ← In | Enrollment | Enrollment Update — Subjects 01-002 Through 01-004 Consented | Closed | Draft Response |
| 16 May 2025 16:00 | → Out | Protocol Clarification | Re: Protocol Clarification Request — Section 4.1 Inclusion Criteria | Closed | Draft Response |
| 16 May 2025 09:00 | ← In | Protocol Clarification | Protocol Clarification Request — Section 4.1 Inclusion Criteria | Closed | Draft Response |
| 02 May 2025 10:00 | ← In | Enrollment | Enrollment Update — Subject 01-001 Screened Successfully | Closed | Draft Response |
| 18 Apr 2025 14:30 | → Out | Logistics / Admin | Re: Site Initiation Visit Confirmation — Site 01 Brussels | Closed | Draft Response |
| 18 Apr 2025 09:00 | ← In | Logistics / Admin | Site Initiation Visit Confirmation — Site 01 Brussels | Closed | Draft Response |
| SAE ID | Type | Severity | Awareness Date | Deadline | Status | Actions |
|---|---|---|---|---|---|---|
| SAE-003 | SAE | Serious | 05 Oct 2025 | 20 Oct 2025 | Closed | View |
Total Communications
26
Open Communications
0
Pending Reviews
0
Communication Breakdown by Category
| Category | Count |
|---|---|
| Monitoring | 8 |
| Enrollment | 5 |
| CAT-QRY | 4 |
| Safety / Vigilance | 2 |
| CAT-SUP | 2 |
| Protocol Clarification | 2 |
| Logistics / Admin | 2 |
| Regulatory / Ethics | 1 |