The Bioresearch Monitoring (BIMO) program is an FDA initiative designed to protect the rights, safety, and welfare of human research subjects in FDA-regulated clinical studies. Established in 1977, BIMO also ensures the accuracy and reliability of study data submitted for research or marketing applications and assesses compliance with relevant laws and FDA regulations.
The program operates through multiple compliance programs (CPs), which provide standardized guidance and inspection procedures for regulated entities. These CPs help ensure that clinical studies and research organizations follow applicable laws, regulations, and standards.
FDA's Office of Regulatory Affairs (ORA), specifically the Office of Bioresearch Monitoring Operations (OBIMO), conducts inspections as part of the BIMO program. These inspections cover:
- Clinical investigators
- Sponsors and sponsor-investigators
- Contract research organizations (CROs)
- Institutional review boards (IRBs)
- Radioactive drug research committees (RDRCs)
- Nonclinical (animal) studies
- Bioavailability and bioequivalence (BA/BE) studies
See also
Another relevant pages
Links to this page
References
External links
- FDA website Bioresearch Monitoring Program (BIMO) Compliance Programs Accessed Feb 2025
- Compliance Program 7348.810: Sponsors and CRO https://www.fda.gov/media/75916/download
- Compliance Program 7348.811: Clinical Investigators and Sponsor-Investigators https://www.fda.gov/media/75927/download