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

​Pre-IND Meeting Templates

• Pre-IND Meeting Request Template 
• Pre-IND Meeting Briefing Package Template 
• Pre-IND Meeting Briefing 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 

Investigator’s Brochure Template

• Investigator’s 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

• Submission Labels
• Safety Letter Instruction Sheet  
• A Guide to Financial Disclosures
• Glossary

Sponsor-Investigator IDE Templates

Pre-Submission Templates

• Pre-Submission Template (general) 
• Pre-Submission Template (IVD) 
• Pre-Submission Cover Letter Template 

Study Risk Determination Templates

• Study Risk Determination Template 
• Study Risk Determination Cover Letter Template 

Initial IDE Templates

• IDE Template Instruction Sheet 
• IDE Template 
• IDE Cover Letter Template (CDRH) 
• IDE Investigator Agreement Template  

Progress Report Template

• Progress Report Template 
• Notes on Supplements, Reports, and Amendments

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

• FDA Orphan Drug Designation Request Form 
• Orphan Drug Designation Request Cover Letter Template 

Annual Progress Report

• Orphan Drug Designation Annual Report Template
• Orphan Drug Designation Annual Report Cover Letter Template 

Financial Disclosure Template

• Financial Disclosure Template

Protocol Templates

• Clinical Protocol Template 
• NIH FDA Protocol Template

NIH Registration for Human Gene Transfer Protocols

• NIH Protocol Registration and RAC Review Instruction Sheet 
• NIH Protocol Registration Template 
• NIH Safety Reporting Template 
• NIH Protocol Initiation of Clinical Investigation Template