Cross-study view

Platform Risk Register

Every cro.study_risk row in one filterable view. Counts below reflect the full platform; filter to drill into a single study, severity, or owner.

17 active · 1 critical · 4 high · 9 medium · 8 low · 5 closed

Filtered view

Filtered view

Showing 5 of 22 risks across the portfolio.

Risks by severity

Medium2 risks

Title	Owner	Study	Status	Mitigation
IRT vendor outage on 2026-04-12 caused 14 mis-randomisations	Data Management Lead	RARE-007Northwind Genetics	Closed	Vendor RCA delivered; all subjects reconciled; CAPA closed.
Reactogenicity rate slightly above comparator	Medical Monitor	VAX-014Stellis Vaccines	Closed	Independent DSMB review at 50% enrolment: continue unchanged.

Low3 risks

Title	Owner	Study	Status	Mitigation
Subjective endpoint reader drift	Medical Monitor	DERM-003Lyra Skin Sciences	Closed	Calibration sessions every 90 days; QC audit at 50% enrolment passed.
Late-arriving AE narratives at DB lock	Pharmacovigilance Lead	OBS-PMR-001Veridian Pharma	Closed	All narratives QC-cleared; lock executed without amendment.
Investigator turnover at top-3 enrolling site	CRA Manager	ONC-002Acme Therapeutics	Closed	Sub-investigator certified and trained.