Additional Documents and Forms
New PI Separation Checklist!
OHRE and the IRB have created a new form for principal investigators (PIs) who are:
- Closing their study
- Transferring their study to a new PI
- Transferring their study to a new institution
A departing PI should complete the PI Separation Checklist and email it to irb_questions@unc.edu at least 45 days before departure.
Device-Related
- HUD Addendum Completion Instructions
- Humanitarian Use Device (HUD) Application Addendum
- Investigational Device Guidance Document
- Investigational Device (IDE) Worksheet
- Expanded Access Devices Addendum
- Expanded Access Drugs/Devices Addendum Instructions
- Expanded Access Devices Informed Consent Form Template
Drug-Related
- Expanded Access Drugs Addendum
- Expanded Access Drugs/Devices Addendum Instructions
- Expanded Access Drugs Informed Consent Form Template
- IND Exemption Checklist
Recruitment
Miscellaneous
- International Research Guidance and Worksheet
- Lead Site/Coordinating Center Addendum
- OHRP International Compilation of Human Research Standards
- PI Separation Checklist
- Perioperative Review Form
- Protocol Deviation Tracking Log
- Protocol Exception Request Form
- Report of Emergency Use of a Test Article to the IRB
- Verification of Foreign Language Translation