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Regulatory Focus™ > News Articles > FDA Makes Changes to Bioresearch Monitoring Information System

FDA Makes Changes to Bioresearch Monitoring Information System

Posted 09 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new updates to the Bioresearch Monitoring Information System (BMIS) on 9 January.  The program is used by FDA to oversee regulated clinical trials.

According to FDA, BMIS "provides controls to ensure that clinical investigators meet the requirements of the relevant statutes and regulations governing FDA-regulated products." This, in turn, supports the bioresearch monitoring (BIMO) program.

The changes to BMIS include:

  • general system updates, including new FDA offices;
  • adding categories, including the financial interests of sponsors and investigators;
  • deleting redundant disclosure forms that are precluded by legislation;
  • adding disclosure categories to include more agencies, institutions, authorities, and organizations;
  • adding disclosure categories to provide for disclosure to sponsors, institutional review boards and other entities if that information is relevant to their oversight responsibility;
  • providing for disclosure to communicate research misconduct proceedings to research subjects;
  • providing for disclosure of information to oversight authorities, including FDA officials and Department of Health and Human Services contractors; and
  • providing for the disclosure of regulatory information to the public, including untitled letters and warning letters.

BIMO inspections are undertaken by field inspectors from the Office of Regulatory Affairs (ORA), while each relevant center (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, etc) maintains oversight over inspections.

FDA noted in the Federal Register (FR) document that the system is intended to support regulatory or procedural controls to ensure the compliance of all clinical investigations, and to support the effective performance of the BIMO program.

The FR listing also elaborates on the storage and retrieval of documents, document safeguards, notification procedures, access procedures, record contesting procedures, record exemptions and the routine uses of records maintained in the system.

The additions will take effect on 8 February 2012.


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