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Compliance In Focus
Posted by John Lehmann on Fri, Mar 16, 2012

Continued Review of Clinical Trials – IRB Oversight

IRBs Clinical Trial In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.

Last month the FDA finalized the guidance “IRB Continuing Review after Clinical Investigation Approval.” The guidance helps provide a framework for IRBs for reviewing research by investigators, and includes recommendations regarding the continuing review:

• Criteria
• Process
• Frequency
• Communication

In a news-release, the FDA notes that the comments submitted to the draft from January 2010 were incorporated into the finalized version. In fact, “Changes from the draft guidance include more detailed discussion about what should be submitted to assist the IRB in conducting continuing review, clarification of recommendations regarding submission of study-wide information for multi-site studies, discussion of the circumstances in which expedited review procedures may be used for continuing review, and revised guidance about how continuing review dates should be determined.”

The finalized guidance also provides direction on which key topics to consider during continuing review. These topics include:

• Risk Assessment
• Adequacy of Process for Obtaining Informed Consent
• Local Issues
• Trial Progress

While this document was issued to help direct IRBs, this will provide support to the whole study team- from sponsors to Investigators- to know their responsibilities and help keep patients protected. Did you submit comments on the draft guidance?  Do you feel the guidance caught all of the key topics? Post your thoughts below!

Photo Credit: jakebouma


Topics: Medical Device CRO, IRB Oversight, 21 CFR Part 56


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