Glossary
Also referred to as a "Statement of Investigator," it is a requirement of section 505(i) of the Food, Drug, and Cosmetic Act and ¶312.1 of Title 21 CFR, that an investigator complete this form as a condition for receiving and conducting clinical studies involving investigational drugs. For CTE-sponsored studies, the NCI’s Pharmaceutical Management Branch is responsible for collecting this form annually. It includes the investigator's training and experience and provides for legal certifications.