Protocol Deviation Reporting Form (Clinical Research)
Site ID
Protocol Title
Protocol Number
Subject ID
Date of Deviation
Reported By
Description of Deviation
Type of Deviation
Major
Minor
Detected By
Impact/Consequence (e.g., on subject safety or data integrity)
Immediate Corrective Action Taken
Preventive Action (to avoid recurrence)
Notified to (Sponsor, Ethics Committee, etc.)
Date of Notification
Signature
Date Signed