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 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 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

TEAMSS Resources 

TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental therapies. This federated, national consortium for Expanded Access interventions is a partnership led by the University of Michigan with Duke University, University of Rochester and University of Texas Southwestern.  Expanded Access provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics, and medical devices. By developing this national consortium, we will build a positive impact by, for the first time, creating a foundation for an integrated, nationwide approach to Expanded Access that can improve care for the most vulnerable patients.

TEAMSS Website