Good Clinical Practice 101:

An Introduction
Presented by: Lester “Jao” Lacorte, MD

Medical Officer – Commissioner’s Fellow

Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health

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Objectives:

z Define Good Clinical Practice (GCP)

z Outline the goals of GCP
z Provide a historical perspective on GCP
z Outline FDA regulations relating to GCP
in medical device research

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What is Good Clinical Practice (GCP)?

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

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

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Why is GCP important?
z GCP compliance
provides public
assurance that the
rights, safety and
well-being of human
subjects involved in
research are
protected

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What are the goals of GCP?
z To protect the rights, safety and welfare of
humans participating in research

z To assure the quality, reliability and integrity

of data collected

z To provide standards and guidelines for the

conduct of clinical research

z Good Clinical Practice = Ethics + Quality Data

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

z The Nuremberg Code (1947)

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

– Voluntary
participation

– Informed Consent

– Minimization of risk
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GCP: A Historical Perspective
z Declaration of
Helsinki (1964)
– Well-being of subject
takes precedence
– Respect for persons
– Protection of
subjects health and
rights
– Special protection for
vulnerable
populations
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GCP: A Historical Perspective
z
z Belmont Report
Ethical Principles
(1979)
– Respect for Persons
• Informed consent
• Protection of
vulnerable
populations
– Beneficence
• Non-malfeasance
– Justice
• Fairness
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The International Conference on
Harmonisation (ICH-GCP)

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

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What are the 13 principles of ICH-GCP?

z Ethics:
1. Ethical conduct of clinical trials
2. Benefits justify risks
3. Rights, safety, and well-being of subjects prevail
z Protocol and science:
4. Nonclinical and clinical information supports the trial
5. Compliance with a scientifically sound, detailed
protocol

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What are the 13 principles of ICH-GCP? (cont.)

z Responsibilities:
6. IRB/IEC approval prior to initiation
7. Medical care/decisions by qualified physician
8. Each individual is qualified (education,
training, experience) to perform his/her tasks
z Informed Consent:
9. Freely given from every subject prior to
participation
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What are the 13 principles of ICH-GCP? (cont.)

z Data quality and integrity:

10. Accurate reporting, interpretation, and
verification
11. Protects confidentiality of records
z Investigational Products
12. Conform to GMP’s and used per protocol
z Quality Control/Quality Assurance
13. Systems with procedures to ensure quality of
every aspect of the trial

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 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 Regulation15
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International Standards Organization

z 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

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What constitutes Good Clinical
Practice in device research?
z IRB-approved protocol
z Valid Informed Consent
z Monitoring Plan
z Adverse Device Effect Reporting [Adverse
Event (AE) or Serious Adverse Event (SAE)]
z Proper documentation
z Valid data collection/reporting procedures

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Who is responsible for GCP
compliance?
z
z Sponsors
z
z Clinical Investigators (CIs)
z
z Independent Ethics Committees (IECs)
– Institutional Review Boards
Boards (IRBs)
(IRBs)
z
z Contract Research Organizations (CROs)
z
z Research nurses
z
z Clinical Research Coordinators (CRCs)
z
z Clinical Research Associates (CRAs)
z
z Medical monitors
z
z Data entry personnel
z
z Others

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How does FDA implement GCP?
z 21 CFR 11 – Electronic Records & Signatures
z 21 CFR 50 – Protection of Human Subjects
z 21 CFR 54 – Financial Disclosure
z 21 CFR 56 – Institutional Review Boards
z 21 CFR 812 – Investigational Device Exemptions
z 21 CFR 814 – Premarket Approval of Medical
Devices

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

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For further information:

z FDA Good Clinical Practice Regulations

& ICH Guidance

http://www.fda.gov

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