Name the endpoint or blind-integrity threat and identify whether it arises from assessment timing, rater behavior, system flow, local lab/central lab differences, or treatment knowledge.
Problem Play
Blinding Or Unblinding Risk
Use randomization/blinding RACI, IRT readiness, pharmacy workflow map, emergency unblinding pathway, and issue log.
What to do first
Check protocol requirements, assessment manuals, training evidence, vendor review, data transfer, query trend, deviation records, and statistical impact before accepting a green metric.
Escalate if primary endpoint credibility, analysis population, adjudication, blinding, participant safety, or regulatory interpretation could be compromised.
Expected output
Leave the first review with a named owner, dated action, evidence source, escalation threshold, and closure proof. If the issue affects participant protection, endpoint credibility, safety reporting, protocol compliance, critical path, budget authority, vendor scope, or inspection evidence, prepare a decision-ready escalation rather than a status update.