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
- Meeting Request Template
- Pre-IND Meeting Package Template
- EOP Meeting Package Template
- Meeting Package Cover Letter Template
Initial IND Submission Templates
- IND Template Instruction Sheet
- Sponsor Investigator Initial IND Template (simple version)
- Sponsor Investigator Initial IND template (expanded version)
- Initial IND Submission Cover Letter Template (with instructions)
- Initial IND Submission Cover Letter Template (clean)
- Initial IND Submission Cover Letter with Exemption Rationale Template
Investigative Brochure Template
Annual Report Templates
- Annual Report Instruction Sheet
- Annual Report Template (single study)
- Annual Report Template (multi-study)
- Annual Report/Amendment Cover Letter (with instructions)
- Annual Report/Amendment Cover Letter (clean)
Transfer of Ownership Templates
- Sponsor Transfer Cover Letter
- Sponsor Acceptance Cover Letter for Sponsor-Investigators
- Sponsor Acceptance Cover Letter for Multi-Investigator Study
Other Documents
Sponsor-Investigator IDE Templates
Pre-Submission Templates
- Pre-Submission Instruction Sheet
- Pre-Submission Template (general)
- Pre-Submission Template (IVD)
- Pre-Submission Cover Letter Template
- Pre-Submission Meeting Minutes Template
Study Risk Determination Templates
Initial IDE Templates
- IDE Template Instruction Sheet
- IDE Template
- IDE Cover Letter Template (CDRH)
- IDE Investigator Agreement Template
Progress Report Template
Sponsor-Investigator ITP Templates
Investigational Tobacco Product Template
- Investigational Tobacco Product (ITP) Template
- Investigational Tobacco Product (ITP) Cover Letter Template
Orphan Drug Designation Templates
Initial Request
Annual Progress Report
- Orphan Drug Designation Annual Report Template
- Orphan Drug Designation Annual Report Cover Letter Template
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.
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.