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 In this section:

                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
          Center BIMO Program ContactsClinical Trials and Human Subject Protection Center BIMO Program Contacts
  
  	
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    PrintBiological Products (Bioresearch Monitoring Branch, Center for Biologics Evaluation and Research)
	Drug Products (Office of Scientific Investigations, Center for Drug Evaluation and Research)
	Enforcement Information (Office of Enforcement, Office of Regulatory Affairs)
	Food or other products regulated by the Center for Food Safety and Applied Nutrition (Bioresearch Monitoring Program, Office of the Director, CFSAN)
	Medical Devices (Division of Bioresearch Monitoring, Center for Devices and Radiological Health)
	New Animal Drugs(Premarket Compliance and Administrative Actions Team, Center for Veterinary Medicine)Biological Products

Bioresearch Monitoring Branch
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research (CBER)
Telephone: 240-402-8010
Facsimile: 301-595-1245
Email: ocod@fda.hhs.gov

*Contact the Bioresearch Monitoring Branch for questions about:*

The legal status of a test article
	Human subject protection regulations related to biologics
	CBER assigned IRB inspections
	CBER assigned clinical investigator inspections
	Reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a biologic product including:
	unanticipated problems involving risks to subjects
		serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations
		suspension or termination of IRB approval of a protocolDrug Products

Office of Scientific Investigations (OSI)
Office of Compliance
Center for Drug Evaluation and Research (CDER)
Telephone: 301-796-3150
Facsimile: 301-847-8748
Email: CDER-OSI-GCPReferrals@fda.hhs.gov

***Contact the Office of Scientific Investigations for questions about:***

Human subject protection regulations pertaining to drugs (21 CFR Parts 50, 56, 312, 320, 361)
	CDER-assigned IRB inspections
	Reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a drug product including:
	unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)]
		serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108 (b)(2)]
		suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]
	Reporting complaints related to human subject protection/good clinical practice in FDA-regulated drug trialsEnforcement Information

Division of Compliance Policy
Office of Enforcement
Office of Regulatory Affairs
Telephone: 240-632-6800
Fax: 240-632-6810

*Contact the Division of Compliance Policy for questions about:*

FDA’s Bioresearch Monitoring Program, Compliance Programs, and the Good Laboratory Practice (GLP) Program for nonclinical laboratories
	Bioresearch Monitoring Program enforcement issuesFood or other products regulated by the Center for Food Safety and Applied Nutrition

Bioresearch Monitoring Program
Office of Center Director
Center for Food Safety and Applied Nutrition (CFSAN)
Phone: 240-402-1757
Fax: 301-436-2668

*Contact the Bioresearch Monitoring Program for questions about:*

Human subject protection related to studies involving foods or other CFSAN-regulated products
	CFSAN-regulated products include:
	food additives
		color additives
		infant formula
		dietary supplements
	Human subject protection related to petitions for nutrient content claims and health claims
	Reporting complaints related to the conduct of clinical trials of CFSAN-regulated productsMedical Devices

Division of Bioresearch Monitoring
Office of Compliance
Center for Device and Radiological Health (CDRH)
Phone: 301-796-5490
Fax: 301-847-8136
Website: Bioresearch Monitoring

*Contact the Division of Bioresearch Monitoring for questions about:*

Human subject protection regulations pertaining to devices [21 CFR Parts 50, 56, and 812]
	Informed consent, standard operating procedures, records and reports in clinical trials for medical devices
	Serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations involving a medical device [21 CFR 56.108(b)(2)]
	Reporting complaints related to human subject protection/good clinical practice in FDA-regulated medical device trialsNew Animal Drugs

Premarket Compliance and Administrative Action Team
Center for Veterinary Medicine (CVM)
Phone: 240-276-9200
Fax: 240-276-9241

***Contact the Premarket Compliance and Administrative Actions Team for questions about:***

Good clinical practice regulations related to new animal drugs for investigational use (21 CFR Part 511)
	Reporting complaints related to the conduct of studies with new animal drugs for investigational use

                                                                                  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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