Regulatory Resources

 

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

 

INTERACT Meeting Templates (CBER)

​Pre-IND and End-of-Phase Meeting Templates

Initial IND Submission Templates

Investigative 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

 

ReGARDD.org Resources

 

The ReGARDD website is a collaboration between the regulatory affairs specialists from the North Carolina CTSA Institutions and is comprised of helpful tools, templates, decision trees, and educational resources to support academic investigators’ regulatory needs.

 

ReGARDD Website    ReGARDD Flyer