IRB Protocol Deviation/Violation Report Form
Protocol Information
Protocol Title
Protocol Number
Principal Investigator Name
Contact Information
Deviation/Violation Details
Date of Deviation/Violation
Date Discovered
Describe the Deviation/Violation
Location (if applicable)
Personnel Involved
Subject(s) Involved (if applicable)
Type
Minor Deviation
Major Deviation (Violation)
Impact Assessment
Potential Impact on Subject Safety/Data Integrity
Is this deviation/violation reportable to the sponsor or regulatory authorities?
Yes
No
Corrective and Preventive Action
Corrective Actions Taken
Preventive Measures to Avoid Recurrence