IRB MEMBERS
Regulatory Documents:
- OHRP Guidance on Adverse Events
- FDA Guidance on Adverse Events
- OHRP Guidance on Continuing Review
- FDA Guidance on Elements of Informed Consent
- Criteria for Approval
Primary Reviewer Documents:
- Meeting Presentation Worksheet
- Primary Reviewer Checklist
- LAR Checklist Nontherapeutic Research
- LAR Checklist
- Noncompliance Review Considerations
- Pediatric Research Checklist
- Pregnant Women-Fetus Checklist
- Full Committee Modification Checklist
- Prisoners Checklist
- Device Checklist
- Drug Checklist
- UPIRSO Review Checklist