Templates

Investigational New Drug Templates 

Formatting and Submission Requirements (Tip Sheet)

Initial IND Application Templates

1. Initial IND Application (body of application)
2. Clinical Study Protocol (required section of the application)
3. Chemistry, Manufacturing and Control Information (required section of the application)
4. Pharmacology and Toxicology Information (required section of the application)

Required Reports

1. Annual Report
2. Safety Report
3. Withdrawal Request/Final Report

Other Submissions

1. Protocol Amendment – New Investigator
2. Protocol Amendment – New Protocol
3. Protocol Amendment – Change in Protocol
4. Information Amendment
5. Change of Sponsor
6. Change of Sponsor-Investigator

Requests

1. Meeting Requests
2. Inactive Status Request
3. Concurrence of Exemption Request

Form Template

1. Certification/Disclosure of Financial Interest of Clinical Investigators

Investigational Device Exemption Templates

Formatting and Submission Requirements (Tip Sheet)

Initial IDE Application Templates

1. Cover Letter for Original IDE Application
2. Initial IDE Application (body of application)
3. Report of Prior Investigation(s) of the Device (required section of the application)
4. Investigational Plan - Feasibility Study (required section of the application if a feasibility study will be conducted)
5. Investigational Plan - Pivotal Study (required section of the application if a pivotal study will be conducted)
6. Methods, Facilities, and Control Information (required section of the application)
7. Example Investigator's Agreement (required section of the application)

Required Reports

1. Progress Report
2. Safety Report
3. Final Report

Supplements

1. Cover Letter for Supplemental IDE Application
2. Cover Letter for 5-Day Notification

Requests

1. Request for feedback or meeting (Q submission)
2. IDE Exemption Request

Form Template

Certification/Disclosure of Financial Interest of Clinical Investigators