Regulatory Focus™ > News Articles > FDA Releases Final Guidance on Overseeing Clinical Trials

FDA Releases Final Guidance on Overseeing Clinical Trials

Posted 27 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new guidance 27 February on clinical trials oversight occurring after clinical investigation approval (CIA).

Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval finalizes draft guidance by the same name released by FDA in January 2010.

The guidance aims to provide specific recommendations for Institutional Review Boards, sponsors and clinical investigators regarding the criteria, process and frequency of continuing review to ensure the welfare of clinical trial subjects.

According to the guidance, "[a]lthough an IRB may become familiar with various individual aspects of the study's conduct, such familiarity does not relieve the IRB of the responsibility to conduct continuing review, which provides an opportunity to reassess the totality of the study and assure that, among other things, risks to subjects are (1) minimized, and (2) still reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may be expected to result."


Read more:

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Institutional Review Board Continuing Review After Clinical Investigation Approval

Federal Register - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability


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