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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
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug DevelopmentClinical Trials and Human Subject Protection Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
  
  	
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    PrintInternational good clinical practice (GCP) collaboration is a critical component to ensure adequate regulatory oversight and assessment of data integrity given:

Globalized clinical trials and growing numbers of clinical trial sites per study
	Complex, dynamic, clinical trial design and delivery that may require new approaches to preserving data integrity
	Accelerated product approval programs requiring high level of efficiency for marketing applicationsFDA’s Center for Drug Evaluation and Research (CDER) has established collaborations with the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA-UK) and Health Canada to optimize regulatory resources and oversight in the evaluation of clinical trial conduct.

The international GCP collaborations include:

Conducting collaborative GCP inspections
	Sharing inspection observations and findings through inspection sharing agreements
	Convening joint conferences to discuss data integrity in clinical trials
	Sharing knowledge and best practices related to GCP compliance to external stakeholders, including clinical investigators and industry
	Authoring joint publicationsInternational Joint Workshops on Good Clinical Practice (GCP)

Subscribe to the FDA good clinical practice listserv for alerts when new conferences are announced.

FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022)
	FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020
	FDA and MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials (2018) 
	Welcome + Data Quality: Why Do We Care?
			Data Integrity from International Perspectives
			Quality Management Systems and Quality by Design
			Overview of Data Integrity
			Good Clinical Practice Assessment of Data Reliability in Registration Trials
			Quality and Control of Clinical Trial Data
			The Data Management Plan – Pulling It All Together
			Unblinding – Let Me Count the Ways...
			Blinding of Bioequivalence Trials
			Effective Use of Audit Trails
			A Case Example of the Review of Audit Trails in GCP InspectionsPublications, Articles, and Reports

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency. Ther Innov Regul Sci (2022). https://doi.org/10.1007/s43441-022-00417-w
	Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight, International Coalition of Medicines Regulatory Authorities (ICMRA) (November 26, 2021)
	*NOTE: This reflection paper by ICMRA was based on discussions about the combined GCP and GMP regulatory experiences of MHRA, EMA, Health Canada, US-FDA, Swissmedic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO and Saudi-FDA.*
	Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK in Clinical Pharmacology & Therapeutics, Clinical Pharmacology & Therapeutics (August 6, 2021)
	MHRA and US FDA tackle challenging data integrity, MHRA Blog Post (September 1, 2021)
	EMA-FDA and PMDA GCP Pilot Collaboration Report, FDA, (2019)Information Sharing with International Regulatory Authorities

FDA shares information with regulatory authorities that have an established confidentiality commitment. Learn about and search FDA confidentiality commitments.

Contact

Contact gcpquestions@fda.hhs.gov for information on general FDA international collaboration
	Contact lakisha.williams@fda.hhs.gov for information on drug GCP international collaborations with the Center for Drug Evaluation and Research (CDER)Additional Good Clinical Practice Regulatory Resources

Regulations: Good Clinical Practice and Clinical Trials

                                                                                  Content current as of:
      12/23/2021Clinical 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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