Protect participants first: confirm the facts, reporting pathway, accountable safety/medical owner, and urgent site communication boundary.
Problem Play
Safety Signal
Protect participants first, reconstruct facts, route medical determinations to accountable owners, and track escalation.
What to do first
Reconcile source, EDC, safety database, follow-up attempts, consent implications, and approved participant-facing language.
Escalate immediately if participant protection, expedited reporting, consent update, study pause, or DMC/IDMC review may be affected.
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.