Sites & risk-based monitoring

Risk scores combine serious adverse events, open QA findings, and flagged visits. High-risk sites trigger a proposed on-site visit that a CRA must confirm.

Site	Country	Principal investigator	Status	Risk score
Mount Halifax Oncology Center	US	Dr. A. Reyes	activated	0.1
St. Brigid University Hospital	IE	Dr. C. Nolan	activated	0.2
Pacific Trials Institute	US	Dr. M. Okafor	activated	0.0
701 (USA)	USA	Dr. Reyes	activated	0.1
702 (USA)	USA	Dr. Nolan	activated	0.0
703 (USA)	USA	Dr. Okafor	activated	0.2
704 (USA)	USA	Dr. Tanaka	activated	0.1
705 (USA)	USA	Dr. Muller	activated	0.1
706 (USA)	USA	Dr. Rossi	activated	0.0
707 (USA)	USA	Dr. Dubois	activated	0.0
708 (USA)	USA	Dr. Kim	activated	0.1
709 (USA)	USA	Dr. Novak	activated	0.01
710 (USA)	USA	Dr. Silva	activated	0.0
711 (USA)	USA	Dr. Jansen	activated	0.0
713 (USA)	USA	Dr. Kowalski	activated	0.0
714 (USA)	USA	Dr. Clarke	activated	0.0
715 (USA)	USA	Dr. Moreau	activated	0.0
716 (USA)	USA	Dr. Ito	activated	0.0
717 (USA)	USA	Dr. Reyes	activated	0.0
718 (USA)	USA	Dr. Nolan	activated	0.05
SITE001 (USA)	USA	Dr. Reyes	activated	0.39
SITE002 (USA)	USA	Dr. Nolan	activated	0.48
SITE003 (CAN)	CAN	Dr. Okafor	activated	0.37
SITE004 (DEU)	DEU	Dr. Tanaka	activated	0.38
SITE005 (FRA)	FRA	Dr. Muller	activated	0.4
SITE006 (GBR)	GBR	Dr. Rossi	activated	0.63
SITE007 (JPN)	JPN	Dr. Dubois	activated	0.38
SITE008 (KOR)	KOR	Dr. Kim	activated	0.49
SITE009 (AUS)	AUS	Dr. Novak	activated	0.84
SITE010 (ESP)	ESP	Dr. Silva	activated	0.4
SITE011 (ITA)	ITA	Dr. Jansen	activated	0.45
SITE012 (BRA)	BRA	Dr. Kowalski	activated	0.43
SITE013 (USA)	USA	Dr. Clarke	activated	0.68
SITE014 (NLD)	NLD	Dr. Moreau	activated	0.44
SITE015 (POL)	POL	Dr. Ito	activated	0.77

Monitoring visits (2)

on_site 2026-09-01 risk-flagged

Proposed by risk-based monitoring (score 0.84). Pending CRA confirmation.

on_site 2026-09-01 risk-flagged

Proposed by risk-based monitoring (score 0.77). Pending CRA confirmation.