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.