Clinical Investigator Status (Biologics)
Inspections of clinical investigators who have conducted studies with investigational devices reviewed by CBER are carried out as part of the Food and Drug Administration's Bioresearch Monitoring Program. The Clinical Investigator Inspection List contains information on such inspections that were closed after 1989. The list will be updated quarterly.
A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE letter) is issued when FDA believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.