BIMO stands for Bioresearch Monitoring. The FDA releases each year, a list of findings for FDA-regulated product that may be in violation of the agency’s requirements. These inspections’ findings are listed on an FDA Form 483 by the inspector.
Last year, there were over 600 findings from different FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, and good laboratory practices).
For example, Findings related to Clinical investigators were:
- Protocol deviations
- Inadequate recordkeeping
failure to report AEs and informed consent issues
- Among others…
Common IRB deficiencies were:
- Inadequate SOPs
- Subpart D issues
- Inadequate communication with Clinical Investigator/institution
- Among others…
The question we would ask ourselves… what have caused these type of findings? Not enough GCP training? Good clinical practice is mandatory for everyone involved in the conduct of clinical research.
The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). (2.8, E6 Guideline for Good Clinical Practice)
Form 483 Inspection findings
|Observations||Frequency of findings|
|Safety reports (adverse events reporting)||14|
|Informed consent – Failure to obtain informed consent in accordance with 21 CFR Part 50 from each subject prior to drug administration||23|
|Consent form not approved/signed/dated||13|
Additional information about findings and metrics can be found on the FDA website.
Need an ICH GCP refresher? Contact us and we can recommend a few e-learning training.