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 9 of 22 risks across the portfolio.

Risks by severity

Medium9 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.
CSR authoring vendor capacity over Q1 2027	Medical Writing Lead	CV-118Helios Cardio	Mitigating	Backup author identified; CSR shell pre-built.
Single-source device component supply	Supply Chain Lead	DERM-003Lyra Skin Sciences	Mitigating	Buffer stock at 3 months; second-source qualification in progress.
Vendor archive handoff for 6-year retention obligation	Records Lead	OBS-PMR-001Veridian Pharma	Mitigating	Long-term archive contract executed; index re-verified.
CRO sub-contracting central lab going through M&A	CRA Manager	ONC-002Acme Therapeutics	Mitigating	Continuity letter on file; back-up lab identified.
Central reader inter-rater variability above threshold	Medical Monitor	RARE-007Northwind Genetics	Mitigating	Retraining and re-adjudication of 12% of reads in progress.
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.