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                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


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          Clinical Trials and Human Subject Protection
          BIMO Inspection MetricsClinical Trials and Human Subject Protection BIMO Inspection Metrics
  
  	
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    PrintThe slides accessed through the links below provide annual bioresearch monitoring (BIMO) inspection metrics by fiscal year (FY). The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable. These data were provided by the individual Centers and may differ from other inspection data available on FDA’s website, as different criteria and/or methods for compiling the information may have been used. Also provided, at the first link below, is a glossary of acronyms.Sign up to receive free email alerts and updates on annual bioresearch monitoring (BIMO) inspection metrics and compliance observation trends.** FDA Employees: Use Chrome to Subscribe until further notice.*


This page lists the most recent reports. Metrics from previous years can be found in the FDA.gov Archive.

Annual BIMO Inspection Metrics

Acronyms Used in Metric SlidesFY2022
	Bioresearch Monitoring (BIMO) Metrics – FY22

	FY 2022 IRB FDA 483 Observation Trends
		FY 2022 GLP FDA 483 Observation Trends
		FY 2022 Clinical Investigator FDA 483 Observation Trends
		FY 2022 Sponsor FDA 483 Observation Trends

FY2021
	Bioresearch Monitoring (BIMO) Metrics – FY21

	

	The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.

	Email Icon for GovDeliverySign up to receive Recalls, Market Withdrawals and Safety Alerts.** FDA Employees: Use Chrome to Subscribe until further notice.*

	FY 2021 Clinical Investigator FDA 483 Observation Trends
		FY 2021 Sponsor FDA 483 Observation Trends
		
		FY 2021 GLP FDA 483 Observation Trends

FY2020
	Bioresearch Monitoring (BIMO) Metrics – FY’20

	FY 2020 GLP FDA 483 Observation Trends
		FY 2020 Clinical Investigator FDA 483 Observation Trends

Years Prior to 2020
	Bioresearch Monitoring (BIMO) Metrics - FY'19
	Bioresearch Monitoring (BIMO) Metrics - FY'18
	Bioresearch Monitoring (BIMO) Metrics - FY'17
	Bioresearch Monitoring (BIMO) Metrics - FY'16
	Bioresearch Monitoring (BIMO) Metrics - FY'15

                                                                                  Content current as of:
      01/30/2024Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
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