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Introduction to the Bioresearch Monitoring Program (BIMO)
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Introduction to the Bioresearch Monitoring Program (BIMO)
FDA uses Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities. The CPGM’s described below form the basis of FDA’s Bioresearch Monitoring Program. The purpose of each program is to ensure the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application.
FDA’s Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.
How to Make Your Clinical BIMO Ready?
FDA’s BIMO inspections can occur at any time during a clinical trial, it is imperative for biotech manufacturers to be prepared from the very beginning of a clinical study. Below is an overview of common FDA’s BIMO Sponsor/ Monitor/ CRO Findings and Site Investigator Findings.
Sponsor/ Monitor/ CRO Findings:
- Inadequate monitoring
- Failure to bring investigators into compliance
- Inadequate accountability for the investigational product
- Failure to obtain FDA and/or IRB approval prior to study initiation
Site Investigator Findings:
- Failure to follow the investigational plan and/or regulations
- Protocol Deviations
- Inadequate recordkeeping
- Inadequate accountability for the investigational product
- Inadequate communication with the IRB
- Inadequate subject protection- failure to report AEs and informed consent issues
- Being prepared before an inspection occurs is the best thing you can do to reduce your regulatory risk.
It is important to note that FDA also inspects entities outside the United States (OUS). In FY17, CDRH inspected 13 investigators/sites and four sponsors/CROs/monitors and found deficiencies similar to those identified domestically.
BIMO Inspection Checklist:What Leads to a BIMO Inspection?
BIMO inspections occur randomly. This ensures the safety of human research participants. It does not mean that you are doing anything wrong. But there are certain items that make a site visit more likely. For example, if you are a very high enroller, you are more likely to experience an inspection.
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