A Message from the University of Pittsburgh Institutional Review Board
IRB Announcements
New Educational Module Requirement for FDA Regulated Research
Effective April 1, 2007, all principal investigators, listed co-investigators and study coordinators will be required to complete the Good Clinical Practice educational module at the Internet Studies in Education and Research website if they are conducting FDA-regulated research studies.
The IRB considers research to be FDA regulated if it falls under sections 505 (New Drug Application) or 520 (Devices intended for human use) of the Federal Food, Drug, and Cosmetic Act (the Act), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products.
Research involving the "off-label" use of FDA-approved drugs is also considered FDA regulated if any of the following three conditions exists: (1) The research is intended to be reported to the FDA in support of a new labeling indication for the drug or to support any other significant change in the labeling of the drug, (2) or the research is intended to support a significant change in the advertising for the drug, or (3) the research involves a route of administration or dosage level, use in a subject population, or other factor that significantly increases (i.e., compared to the FDA-approved indication for use of the drug) the risks (or decreases the acceptability of the risks) associated with the use of the drug.
That specific educational module can be accessed at the Internet Studies in Education and Research website:
https://cme.hs.pitt.edu/servlet/IteachControllerServlet?actiontotake=loadmodule&moduleid=1601