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Human Subjects Division (HSD)

Regulatory Updates

FDA: Guidance for IRBs, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions - Disqualification

May 1, 2010 at 6:33am

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.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA's guidance documents means that something is suggested or recommended, but not required.

See: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214008.pdf