Identify whether the problem affects endpoint, safety, eligibility, exposure, disposition, coding, external data, or only administrative cleanup.
Problem Play
Missing Data Trend
Use endpoint traceability, data review plan, query aging, missingness risk register, and SAP impact review.
What to do first
Review query aging, reconciliation, edit checks, UAT status, missingness, protocol deviations, SAP/TLF dependencies, and lock criteria.
Escalate if CTQ data, safety reconciliation, endpoint fields, or analysis populations cannot be made credible by the planned date.
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.