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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


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
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          Clinical Trials and Human Subject Protection
          Workshops and MeetingsClinical Trials and Human Subject Protection Workshops and Meetings
  
  	
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    Print**Workshops and Meetings on Good Clinical Practice and Human Subject Protection**FDA Clinical Trial Requirements Regulations, Compliance, and GCP ConferencesThe Society of Clinical Research Associates and FDA District Offices co-sponsor these conferences on FDA’s clinical trial and human subject protection regulations and requirements.Clinical Investigator Training Course. A collaborative training course hosted by the U.S. Food and Drug Administration, Center for Drug Evaluation and Research’s (CDER’s) Office of Medical Policy (OMP), Small Business and Industry Assistance (SBIA) and University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI).Office for Human Research Protections (OHRP) conferences. OHRP sponsors a variety of national and regional workshops about the roles and responsibilities of researchers, institutional review boards (IRBs), institutional officials, and others to promote the protection of human subjects in research. FDA participates in these programs to provide information about FDA’s regulatory requirements.**Other Meetings**FDA Advisory Committees. FDA uses 50 committees and panels to obtain independent expert advice on scientific, technical, and policy matters to assist in its mission to protect and promote the public health.HHS Secretary's Advisory Committee on Human Research Protections (SACHRP)The Secretary’s Advisory Committee on Human Research Protections (SACHRP) provides expert advice and recommendations to the Secretary of HHS on issues pertaining to the protection of human subjects in research. Information about SACHRP meetings and recommendations can be found here.Meetings, Conferences & Workshops (Drugs). A link to meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER), FDA.Meetings, Conferences & Workshops (Medical Devices). A link to meetings, conferences, and workshops sponsored or co-sponsored by the Center for Devices and Radiological Health (CDRH), FDA.

                                                                                  Content current as of:
      09/11/2018Clinical 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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