Regulatory Template Documents

These template documents are meant to serve as a guide. We recommend that you reference the regulations and applicable guidance documents as you prepare your submissions. Please contact our team at ORAQ@duke.edu with any questions or suggestions. 
 

Sponsor-Investigator IND Templates

 

​Pre-IND Meeting Templates

Initial IND Submission Templates

Investigator’s Brochure Template

Annual Report Templates

Transfer of Ownership Templates

Other Documents

 

Sponsor-Investigator IDE Templates

 

Pre-Submission Templates

Study Risk Determination Templates

Initial IDE Templates

Progress Report Template

 

Sponsor-Investigator ITP Templates

 

Investigational Tobacco Product Template

 

Orphan Drug Designation Templates

 

Initial Request

Annual Progress Report

 

Financial Disclosure Template

 

Protocol Templates

 

NIH Registration for Human Gene Transfer Protocols