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FDA’s BiMo Program April 8, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

The FDA’s clinical Bioresearch Monitoring oversight program assesses the quality and integrity of data submitted to the FDA for new product approvals as well as examines the human subject protection aspects of the study.  As comprehensive program of on-site inspections and data audits the BIMO program performs randomly selected routine inspections to verify clinical studies submitted to the FDA to support a marketing application.  On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have already been identified.  The inspection of a clinical study sometimes uncovers evidence of fraud or misconduct and it must be decided how to handle the investigator and deal with the suspect data.  The prevention of fraud and misconduct is the best way to deal with compliance issues in clinical research.  While training doesn’t guarantee quality, it helps to ensure that all individuals understand the rules and the consequences of misconduct.



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