Identify the exact sample, visit window, custody step, lab transfer, freezer/shipping condition, and subject-period impact.
Problem Play
Pk Sampling Window Risk
Use protocol-to-operations traceability, schedule network analysis, central lab readiness, sample custody controls, and deviation triage.
What to do first
Reconcile source records, sample manifest, chain of custody, lab receipt, protocol window, deviation classification, and statistical evaluability impact.
Escalate if PK evaluability, BA/BE conclusions, safety interpretation, repeat dosing, washout timing, or bioanalytical credibility 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.