Docket Number – FDA-2010-D-0265
Issued Date – 12/01/2022
Issued By – Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, & Office of Good Clinical Practice
This Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices if FDA determines that the investigator has repeatedly or deliberately violated the agency’s regulations, or has repeatedly or deliberately submitted false information to the sponsor or FDA in any required report.