Clinical Trial Protocol Deviation Report
General Information
Protocol Title
Protocol Number
Site Name
Subject ID
Date of Deviation
Reported By
Date Reported
Deviation Details
Description of Deviation
Type of Deviation
Major
Minor
Relevant Protocol Section(s)
Actions & Assessment
Immediate Actions Taken
Impact Assessment
Corrective/Preventive Actions
Review & Sign-off
Investigator/Coordinator Signature
Date