Clinical Trial Protocol Peer Reviewer Form

Reviewer Information

Name Email Affiliation Date of Review

Protocol Details

Protocol Title Protocol Number/ID Principal Investigator Sponsor

Review

1. Scientific Rationale and Background 2. Study Design (Objectives, Endpoints, Methodology) 3. Ethical Considerations 4. Inclusion/Exclusion Criteria 5. Statistical Analysis Plan 6. Data Management and Monitoring 7. Safety Assessment and Adverse Event Reporting 8. Informed Consent Process 9. Overall Comments and Recommendations

Overall Assessment

Recommendation Approve Approve with Minor Revisions Major Revisions Required Reject Final Comments