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# BIMO Metrics Show Major Inspection Declines
- URL: https://www.fdaweb.com/bimo-metrics-show-major-inspection-declines/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151576

Just-released FDA Bioresearch Monitoring (BIMO) Program [metrics ](https://www.fda.gov/media/156517/download?ref=fdaweb.com)[report](https://www.fda.gov/media/156517/download?ref=fdaweb.com) for fiscal year (FY) 2021 shows substantially fewer clinical investigator (CI) inspections conducted due to Covid-19 travel restrictions.

In FY 2019 and before Covid had been detected, CDER conducted 574 CI inspections, but in FY 2021 that number fell to 327 inspections, a 43% drop in inspections. For CDRH, 126 such inspections were conducted in FY 2019 and in FY 2021 that fell to 27 — a 79% decline.

The BIMO metrics list common clinical investigator inspectional observations for 2021 as:  

- Failure to follow the investigational plan; protocol deviations
- Inadequate and inaccurate case history records; inadequate study records
- Inadequate accountability or control of the investigational product
- Failure to comply with Form FDA 1572 requirements
- Inadequate subject protection; informed consent issues
- Safety reporting; failure to report or record adverse events
- Failure to comply with 21 CFR part 56 (IRB) requirements.

Additionally, the metrics show even worse declines for inspections of institutional review boards. In FY 2019, there were 90 CDER-directed IRB inspections, but last year that had fallen to just 11 IRB inspections — a 90% decline. And CDRH fell from 37 inspections in 2019 to 15 inspections in 2021\. The following are the common institutional review board inspectional observations for last year:  

- Failure to conduct initial or continuing review of research
- Failure to have minutes of IRB meetings in sufficient detail to show attendance at the meeting; vote actions, quorum issues
- Failure to conform to membership criteria listed in 21 CFR107
- Failure to follow FDA regulations regarding expedited review procedures
- Inadequate written procedures for prompt reporting of non-compliance, suspension or termination
- Failure to prepare and maintain documentation of IRB activities; inadequate copies of research proposals and related documents