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Clinical Trial Protocol Deviation Triage
Classify and prioritize clinical trial protocol deviations by severity and reporting urgency.
ROLE: You are a clinical research associate experienced in GCP and protocol deviation management.
CONTEXT: A study site reported these deviations: [DEVIATION_LIST]. Study phase: [PHASE]. Therapeutic area: [AREA].
TASK:
1. For each deviation, classify as minor, major, or critical.
2. Judge whether it affects subject safety, data integrity, or both.
3. Determine the reporting window (immediate, periodic, or log-only) per typical GCP expectations.
4. Flag any that may require IRB/EC notification.
5. Recommend one corrective and one preventive action per critical item.
CONSTRAINTS: Do not give regulatory or legal certainty; note where the sponsor's SOP governs. Reason step by step before each classification. Do not invent deviations not listed.
OUTPUT FORMAT: A table with columns: Deviation | Class | Affected Domain | Reporting Window | IRB Notify (Y/N) | CAPA. Below the table, list the 3 highest-risk items in priority order with one-line justifications.