Clinical Trial Protocol Deviation Triage

Triage summary

The timing excursion is confirmed: the specimen was collected 14 minutes after the target and 9 minutes beyond the allowed upper limit. The supplied record does not establish participant harm, but it also does not include a completed safety assessment. Data interpretability remains unresolved because the effect of the delay on the PK endpoint was not supplied. Two prior similar events create a recurrence signal.

Evidence matrix

• Protocol compliance: CONFIRMED DEVIATION — expected window and actual timestamp are both supplied.
• Participant safety: DECISION REQUIRED — no symptoms are documented, but qualified safety review is missing.
• Data reliability: DECISION REQUIRED — assay and PK-impact evidence are absent.
• Recurrence: ESCALATED — two related events were reported in the same month.
• Containment: PARTIAL — specimen control is documented; workflow control restoration is not.
• Root cause/CAPA: OPEN — centrifuge alarm is an initiating condition, not yet a verified root cause.

Provisional route

EXPEDITED SPONSOR REVIEW. This is a routing outcome, not a serious-noncompliance, eligibility, exclusion, or reportability conclusion.

Next evidence

Obtain the participant-safety assessment, bioanalytical/PK impact review, current SOP decision rule, alarm and maintenance history, and named sponsor decision owner.