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Food and Drug Administration, DHHS.


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.


A formal, written agreement with the Office for Human Research Protections (on behalf of the Secretary of DHHS) and an institution which conducts or supports DHHS sponsored research involving human subjects.