Investigational New Drug (IND) 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