Introduction to Good

Clinical Practices
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Objectives

• Define Good Clinical Practice (GCP)

• Outline the goals of GCP

• Provide a historical perspective on GCP

• Give an Overview of the Content of ICH GCP E6

• Give a summary of GCP regulations

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What is Good Clinical Practice (GCP)?

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Good Clinical Practices

 Good clinical practice (GCP) is an international ethical and

scientific quality standard for
 designing, conducting, recording, monitoring and reporting trials
that involve the participation of human subjects.

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Rationale for GCP in clinical Trials

• Compliance with this standard provides public assurance that the

rights, safety and wellbeing of trial subjects are protected, consistent
with the principles that have their origin in the Declaration of
Helsinki, and that the clinical trial data are credible.

• GCP should be followed when generating clinical trial data that are
intended to be submitted to regulatory authorities.

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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

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Key Concepts of GCP

• ICH E6 GCP has the following content:

1. 1. Glossary- definitions and terms used in clinical research

2. 2. Principles of ICH GCP
3. 3. Institutional Review Board/Independent Ethics
Committee(IRB/IEC)
4. 4. Investigator
5. 5. Sponsor
6. 6. Clinical Trial Protocol
7. 7. Investigator’s Brochure
8. 8. Essential Documents

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Foundations for the ethical conduct of

clinical research
• The Nuremberg Code (1947)

• The Declaration of Helsinki (1964)

• The Belmont Report (1979)

• International Conference on Harmonization (ICH-GCP)

• International Organization for Standardization (ISO) 14155

• Code of Federal Regulations

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GCP: A Historical Perspective 1

• Nuremberg Code (1947)

• Voluntary participation

• Inform consent

• Minimizing risk

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GCP: A Historical Perspective 2

 Declaration of Helsinki (1964):

• Well-being of subject takes precedence over research/society

• Respect for human subjects/participants

• Protection of subjects health and rights

• Special protection for vulnerable populations

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GCP: A Historical Perspective 3

• Belmont Report, Ethical Standards (1979)

 Respect for human subjects/participants

▪ Signing of ICF
▪ Special protection for vulnerable subjects

 Beneficence

▪ Non-malfeasance

 Justice

▪ Fairness

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GCP: A Historical Perspective 4

• GCP is an international quality standard that is provided by the

International Conference on Harmonization (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

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Overview of ICH GCP
 13 Principles of ICH GCP
• Ethics
▪ 1. Clinical trials should be conducted in accordance with the ethical principles-
declaration of Helsinki and regulatory requirements
▪ 2. Benefits outweigh risk
▪ 3. Rights, safety, and well-being of subjects prevail over science & society

• Sound Protocol and Science

▪ 4. Nonclinical and clinical information supports the trial
▪ 5. Clinical trials should be scientifically sound, and described in a clear, detailed
protocol.

• Responsibilities
▪ 6. Compliance with the protocol approved by IRB/IEC prior to trial initiation
▪ 7. Medical Care /Decisions by qualified physician or dentist
▪ 8. Individuals given responsibility on the trial should be qualified by education,14
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13 Principles of ICH GCP (cont.)

 InformConsent:
9. Freely given from each subject prior to participation

Data Quality and integrity

10. accurate reporting, interpretation, and verification of all clinical trial
data
11. Protects confidentiality of records

Investigational Products (IP)

12. IP should be manufactured, handled, and stored per GMP and used as
per the approved protocol.

 Quality Assuranceand Quality Control

13. systems with procedures that assures quality of every aspect of the
study
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ISO 14155

• 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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Overview of the Clinical Trial Process

Design of Protocol

Sponsor investigator

Protocol Submission

Site IRB/IEC/ RA

Trial Initiation

Investigator Meeting Review of Protocol/ Site SOP

Monitoring

Sponsor RA /DSMB

Data Analysis

Reporting Study Closure

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What to look for during approval

• IRB-approved protocol
• Study Design

▪ Primary objectives
▪ Secondary objectives
• Valid Informed Consent
• Current Version of Investigator’s Brochure
• Monitoring Plan
• Adverse Device Effect Reporting [Adverse Event (AE) or Serious
Adverse Event (SAE)]
• Proper documentation
• Valid data collection/reporting procedures

▪ Source document
▪ eCRF
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Compliance with GCP

• 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)/ Monitors

• Medical monitors

• Data entry personnel

• Others
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GCP Regulations

 US FDA 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

EU GCP
EudraLex - Volume 10 Clinical trials guidelines
• Chapters I-VI
• Clinical Trial “Directives Directive2001/20/EC”
• GCP Directive “Directive 2005/20/EC”
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GCP Guidelines

 WHO GCP:
• Handbook for Good Clinical Research Practices 2005
• WHO Technical Report Series, No. 850, 1995, Annex 3

 ICH GCP
• E6 Good Clinical Practices

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