Decide whether this is a one-site deviation, repeat process drift, protocol ambiguity, training failure, or a formal amendment need.
Problem Play
Deviation Recurrence
Use issue log, root-cause analysis, CAPA, monitoring plan update, and effectiveness check.
What to do first
Map affected consent, eligibility, endpoint, safety, visits, systems, vendors, budget, timelines, approvals, and re-training requirements.
Escalate if continued execution under the current protocol would put participants, endpoint credibility, regulatory compliance, or inspection reconstruction at risk.
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.