BIMO in Action: AQC Members Share Insights from Recent Inspection Experiences

Posted in Process Improvement

The updates to the Bioresearch Monitoring (BIMO) program for Sponsors and Contract Research Organizations released in September 2021 shed light on FDA’s current thinking on important topics such as the selection and monitoring of clinical investigators and outsourced services. The BIMO program is a comprehensive FDA-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.

BIMO program objectives are “to protect the rights, safety and welfare of human research subjects involved in FDA-regulated clinical studies; to verify the accuracy and reliability of study data submitted to FDA in support of research or marketing applications; and to assess compliance with statutory requirements and FDA’s regulations.” While the Compliance program manuals were created to provide standardized instructions for the conduct of inspections to be followed by field inspectors, in the spirit of transparency, this information is this information is publicly available. This essentially allows Sponsors and CROs the opportunity to ‘see the test’ before taking it.

In July of 2022, the WCG Avoca Quality Consortium (AQC) presented a robust overview of the updates to the BIMO program for sponsors and contract research organizations, and the workshop recording is available for replay. How have these updates changed today’s inspection experiences? Recent feedback from AQC Members’ inspection experiences reflect the new language in the BIMO guide, such as requests for all versions of the written agreements, increased focus on data flow, and request/review of meeting minutes including action item status.

In January of 2023, AQC Members gathered to discuss learnings and strategies to leverage experiences to support inspection readiness activities. AQC Members can view this session in the Knowledge Center webinar archive, as well as register for upcoming meetings on the event calendar. Additional BIMO information is available in the following member resource: INSPA 02 – US FDA Inspection Readiness Agency Resource.

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Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

Published: February 2023