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Additional Documents and Forms

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UNC Research » IRB and the Office of Human Research Ethics » Additional Documents and Forms

Additional Documents and Forms

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

Social Media Plan Example

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

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