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Compliance In Focus
Posted by Elizabeth Braschayko on Thu, Aug 24, 2017

Top 5 Reasons an IRB Receives An FDA Warning Letter

Institutional Review Boards (IRBs) review clinical investigations that the FDA regulates, but theIRB_Warning_Letters_Thumbnail-1.png system of checks and balances goes both ways. The FDA has established regulations regarding IRB oversight, which are intended to protect the rights and welfare of human subjects. The FDA conducts inspections to ensure IRBs comply with these regulations and may issue warning letters for a variety of reasons.

Each year, IMARC Research reviews warning letters the FDA issues to clinical investigators and publishes our findings to help researchers avoid similar issues within their own trials. (We published our findings on 2016 FDA warning letters earlier this month.) This year, we also reviewed warning letters issued to IRBs over the past year to help researchers better understand what the FDA expects of these boards.

The findings outlined in this short whitepaper reiterate the importance of maintaining proper documentation. Some of the most common violations involved the IRB’s failure to conduct continuing reviews, properly notify investigators and maintain written procedures.

IRBs, investigational sites, and monitors need to continue to work together to ensure they are following study protocols, standard operating procedures, and federal regulations. This is a critical step in protecting patient rights, safety and wellbeing during clinical trials. It’s also what motivates our team to work so closely with researchers to ensure compliance at every stage in the clinical trial lifecycle.

I encourage you to take a look at the violations outlined in this whitepaper and share your thoughts. Feel free to get in touch with us if you have questions or concerns after reading it.

Top 5 Reasons an FDA Warning Letter is Issued to an IRB

Topics: FDA Warning Letters


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