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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
          HSP/BIMO InitiativeClinical Trials and Human Subject Protection HSP/BIMO Initiative
  
  	
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    PrintReports accessible from this site provide updates on the Human Subject Protection (HSP)/Bioresearch Monitoring (BIMO) Initiative.  Launched in 2006 as a part of the Critical Path Initiative, the HSP/BIMO Initiative is aimed at modernizing and strengthening the agency's oversight and protection of subjects in clinical trials and the integrity of resulting data. The HSP/BIMO Initiative encompasses all FDA-regulated clinical trials, that is, those related to human drugs and biological drug products, devices, foods, and veterinary medicine. The overarching goals of the agency's BIMO program are to protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; to determine the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and to assess compliance with FDA's regulations governing the conduct of clinical trials, including those for informed consent and ethical review.

HSP/BIMO Initiative Accomplishments

FDA's HSP/BIMO Initiative Accomplishments: Update June 2014
	FDA's HSP/BIMO Initiative Accomplishments: Update May 2012
	FDA's HSP/BIMO Initiative Accomplishments: Update September 2010
	FDA's HSP/BIMO Initiative Accomplishments: Update March 2009

                                                                                  Content current as of:
      04/22/2019Clinical 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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