Log the request exactly, identify owner and source record, and prevent informal response promises before quality/regulatory review.
Problem Play
Inspection Request
Build an evidence package: what was known, when, by whom, what action, and where filed.
What to do first
Build a chronology of what was known, decided, corrected, communicated, and filed.
Escalate if records are missing, inconsistent, safety-relevant, sponsor-oversight-relevant, or likely to create a commitment to an inspector.
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.