Basics of the IND

The IND in Detail - Items 1-6

• IND Item 1: Form FDA 1571
• IND Item 2: Table of Contents
• IND Item 3: Introductory Statement
• IND Item 4: General Investigation Plan
• IND Item 5: Investigator’s Brochure
• IND Item 6: Protocols

• Adequate and Well-controlled Trials
• Adaptive Study Designs
• Comparative Effectiveness Research (CER)
• Patient Reported Outcomes
• Surrogate Endpoints
• The Animal Efficacy Rule
• Qualification of Drug Development Tools
• Foreign Clinical Trials
• Changes to the Investigational Drug
• Financial Disclosure by Clinical Investigators