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 4 of 22 risks across the portfolio.

Risks by severity

Critical1 risk

Title	Owner	Study	Status	Mitigation
Sample size insufficient at current event rate	Biostatistics Lead	RARE-007Northwind Genetics	Open	Type B FDA meeting requested to discuss adaptive SSR; protocol amendment v4 draf…

High1 risk

Title	Owner	Study	Status	Mitigation
EAC has breached contracted budget	Finance Lead	RARE-007Northwind Genetics	Open	Change order in negotiation; sponsor steering committee notified.

Medium2 risks

Title	Owner	Study	Status	Mitigation
Higher than expected screen failure on creatinine clearance criterion	Medical Monitor	ONC-002Acme Therapeutics	Open	Protocol amendment v3 in draft to relax CrCl from 60 to 50 mL/min.
Central lab assay validation re-run required after method update	Lab Lead	VAX-014Stellis Vaccines	Open	Re-run scheduled; analytical bridge plan agreed.