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U.S. Department of Health and Human Services

Training and Continuing Education

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Presentation: Good Clinical Practice 101: An Introduction

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Presented by: Lester “Jao” Lacorte, MD

Medical Officer – Commissioner’s Fellow
Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health

Objectives:

  • Define Good Clinical Practice (GCP)
  • Outline the goals of GCP
  • Provide a historical perspective on GCP
  • Outline FDA regulations relating to GCP in medical device research

What is Good Clinical Practice (GCP)?

  • GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies

Additional terms defined:

  • Clinical Investigation
  • Clinical Investigator
  • Human Subject
  • Institutional Review Board

Why is GCP important?

  • GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected

What are the goals of GCP?

  • To protect the rights, safety and welfare of humans participating in research
  • To assure the quality, reliability and integrity of data collected
  • To provide standards and guidelines for the conduct of clinical research
  • Good Clinical Practice = Ethics + Quality Data

What are the foundations for the ethical conduct of clinical research?

  • The Nuremberg Code (1947)
  • The Declaration of Helsinki (1964)
  • The Belmont Report (1979)
  • International Conference on Harmonisation (ICH-GCP)
  • International Standards Organization 14155
  • Code of Federal Regulations

GCP: A Historical Perspective

  • Nuremberg Code (1947)
    • Voluntary participation
    • Informed Consent
    • Minimization of risk
  • Declaration of Helsinki (1964)
    • Well-being of subject takes precedence
    • Respect for persons
    • Protection of subjects health and rights
    • Special protection for vulnerable populations
  • Belmont Report Ethical Principles (1979)
    • Respect for Persons
      • Informed consent
      • Protection of vulnerable populations
    • Beneficence
      • Non-malfeasance
    • Justice
      • Fairness

The International Conference on Harmonisation (ICH-GCP)

  • GCP is an international quality standard that is provided by the International Conference on Harmonisation (ICH)
  • Goals: Harmonize technical procedures and standards; improve quality; speed time to market
  • In 1997, the FDA endorsed the GCP Guidelines developed by ICH
  • ICH guidelines have been adopted into law in several countries, but used as guidance for the FDA in the form of GCP

What are the 13 principles of ICH-GCP?

  • Ethics:
    1. Ethical conduct of clinical trials
    2. Benefits justify risks
    3. Rights, safety, and well-being of subjects prevail
  • Protocol and science:
    1. Nonclinical and clinical information supports the trial
    2. Compliance with a scientifically sound, detailed protocol
  • Responsibilities:
    1. IRB/IEC approval prior to initiation
    2. Medical care/decisions by qualified physician
    3. Each individual is qualified (education, training, experience) to perform his/her tasks
  • Informed Consent:
    1. Freely given from every subject prior to participation
  • Data quality and integrity:
    1. Accurate reporting, interpretation, and verification
    2. Protects confidentiality of records
  • Investigational Products
    1. Conform to GMP’s and used per protocol
  • Quality Control/Quality Assurance
    1. Systems with procedures to ensure quality of every aspect of the trial

A Comparison

DECLARATION OF HELSINKI:
  • Ethical principles
    e.g. ethical and scientific
  • Focus: Physicians in research
  • World Medical Assembly- International medical societies
  • Guidance with broad recommendations
ICH-GCP:
  • Broader principles e.g. ethical, scientific & operational for designing, conducting, reporting & recording trials
  • Focus: Drug sponsors, investigators & IRB
  • Representatives from industry and public health
  • Guidance document but has the effect of law when put into Regulation

International Standards Organization

  • ISO 14155: Clinical Investigation of Medical Devices for Human Subjects
    • Assists sponsors, monitors, and clinical investigators in the design and conduct of device clinical investigations
    • Assists regulatory bodies and ethics committees in their roles of reviewing clinical investigational plans

What constitutes Good Clinical Practice in device research?

  • IRB-approved protocol
  • Valid Informed Consent
  • Monitoring Plan
  • Adverse Device Effect Reporting [Adverse Event (AE) or Serious Adverse Event (SAE)]
  • Proper documentation
  • Valid data collection/reporting procedures

Who is responsible for GCP compliance?

  • Sponsors
  • Clinical Investigators (CIs)
  • Independent Ethics Committees (IECs)
    • Institutional Review Boards (IRBs)
  • Contract Research Organizations (CROs)
  • Research nurses
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Associates (CRAs)
  • Medical monitors
  • Data entry personnel
  • Others

How does FDA implement GCP?

  • 21 CFR 11 – Electronic Records & Signatures
  • 21 CFR 50 – Protection of Human Subjects
  • 21 CFR 54 – Financial Disclosure
  • 21 CFR 56 – Institutional Review Boards
  • 21 CFR 812 – Investigational Device Exemptions
  • 21 CFR 814 – Premarket Approval of Medical Devices

Summary:

  • Defined Good Clinical Practice (GCP)
  • Outlined the goals of GCP
  • Presented a historical perspective on GCP
  • Outlined FDA regulations relating to GCP in medical device research

For further information:

  • FDA Good Clinical Practice Regulations & ICH Guidance