Addresses U.S. Food and Drug Administration-regulated clinical research and the responsibilities of researchers, IRBs, and sponsors when an FDA-regulated product is utilized in a study. In particular, it includes information on when an Investigational New Drug (IND) application is necessary and the requirements of Form FDA 1572. Medical devices research, including defining a medical device, classifying risk, and when an investigational device exemption (IDE) is needed are also presented. Lastly, it addresses FDA regulations about informed consent, emergency use, and 21 CFR Part 11 and electronic records and signatures.
Recommended Use: Elective
ID (Language): 12 (English), 1493 (Spanish)
Author(s): Susan Kornetsky, MPH - Children's Hospital, Boston; David G. Forster, JD, MA, CIP - Western IRB; Gary L. Chadwick, PharmD, MPH, CIP - The University of Rochester