Regulatory Focus™ > News Articles > FDA Announces Additional Restrictions on Disqualified Clinical Investigators

FDA Announces Additional Restrictions on Disqualified Clinical Investigators

Posted 27 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is announcing changes to its rules governing how clinical investigators are disqualified, vastly expanding the scope of the disqualification.

Under existing rules, if FDA determined a clinical investigator has broken rules such that the agency disqualifies them from conducting clinical investigations on one type of test article (e.g. drugs), they may still be allowed to investigate other, non-related products (e.g. medical devices).

Under FDA's new final rule, Disqualification of a Clinical Investigator, if the agency determines that a clinical investigator is no longer eligible to test one kind of product, "the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA."

The agency said in a Federal Register statement that the rule was based on the findings of the Government Accountability Office, which had called attention to the loophole in an earlier report.

The rule intended to "help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA," the agency said.


Read more:

FDA - Disqualification of a Clinical Investigator


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