The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.

1. Overview of ICH-GCP Guidelines
ABEL C. MATHEW
PharmD Student
AL SHIFA COLLEGE OF PHARMACY
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2. CONTENTS
 Introduction
 Historical Background
 Sections
 Principles
 Ethics committee
 Responsibilities of sponsor, Investigator and monitor
 Investigators Brochure
 Informed consent process
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Overview of ICH-GCP guidelines

3. Good clinical practice (GCP): a standard for the design , conduct,
performance, monitoring, auditing, recording, analyses and reporting of
clinical trials that provides assurance that the data and reported results are
credible and accurate and that the rights, integrity, and confidentiality of
trial subjects are protected.
GOOD CLINICAL PRACTICES
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Overview of ICH-GCP guidelines

4. Overview of ICH-GCP guidelines
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The guideline was developed with consideration of the current
good clinical practices of the European union, Japan, and the
United States, as well as those of Australia, Canada, the Nordic
countries and the world health organization
ICH-GCP is an International Conference on Harmonization Good
Clinical Practice.

5. OBJECTIVES
Overview of ICH-GCP guidelines
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1. To protect the rights of human subjects participating in clinical trials
2. To ensure the scientific validity and credibility of the data collected in human
clinical studies.
3. More economical use of human, animal and material resources.
4. To provide an unified standard for the European Union, Japan and the United
States to facilitate the mutual acceptance of the clinical data by the regulatory
authorities in these jurisdictions.

6. HISTORICAL BACKGROUND
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Nuremberg Code, 1946
Kefauver Amendments, 1962
Declaration of Helsinki, 1964
Belmont Report, 1979
Overview of ICH-GCP guidelines

7. 7NUREMBERG CODE(1946)
German Physicians conducted medical experiments on prisoners of war without their consent .
Most of the participants of these experiments died or were permanently crippled.
• In December 9, 1946 - American military tribunal opened criminal proceedings against 23 leading
German physicians
• The Nuremberg Code was established in 1948, stating that "The voluntary consent of the human
participant is absolutely essential," Nuremberg Code was the first international document which
advocated voluntary participation and informed consent.
Overview of ICH-GCP guidelines

8. 8KEFAUVER AMENDMENTS(1960)
• 6000-12000 children had congenital anomalies d/t maternal use of Thalidomide.
• 1962 US Senate hearings Kefauver Amendments passed into law - For the first time, drug
manufacturers were required to prove to the FDA the effectiveness of their products before
marketing them
Overview of ICH-GCP guidelines

9. 9DECLARATION OF HELSINKI
• Adopted by the 18th WMA general assembly Helsinki, Finland, June 1964. It has since
undergone seven revisions (the most recent at the general assembly in October 2013) .
• A statement of ethical principles to provide guidance to physicians and other participants
in medical research involving human subjects.
• The Declaration specifically addressed clinical research, reflecting changes in medical
practice from the term 'Human Experimentation' used in the Nuremberg Code
Overview of ICH-GCP guidelines

10. 10TUSKEGEE SYPHILIS STUDY- 1932 TO 1972
The US Public Health Services conducted a Syphilis Study on 600 low income African-
American individuals
• Stopped in 1972
• Led to the 1979 Belmont Report and the establishment of OHRP.
Overview of ICH-GCP guidelines

11. Overview of ICH-GCP guidelines
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1982 INTERNATIONAL GUIDELINES FOR
BIOMEDICAL RESEARCH INVOLVING
HUMAN SUBJECTS.
1996 ICH-GCP GUIDELINES ISSUED.
1997 ICH-GCP GUIDELINES BECOME LAW IN
SOME COUNTRIES.

12. 8-SECTIONS OF ICH- GCP GUIDELINES
• GLOSSARY
1
• PRINCIPLES
OF GCP
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• REQUIREMENTS
FOR IRB/IEC
3
• RESPONSIBILITIES
OF THE SPONSOR
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13. Overview of ICH-GCP guidelines
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• RESPONSIBILITIES
OF THE
INVESTIGATOR
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• CLINICAL
TRIAL
PROTOCOL
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• INVESTIGATOR’S
BROCHURE
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• ESSENTIAL
DOCUMENTS
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14. 1. Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable
regulatory requirement(s).
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against
the anticipated benefit for the individual trial subject and society. A trial should be initiated
and continued only if the anticipated benefits justify the risks.
3. The rights, safety, and well-being of the trial subjects are the most important considerations
and should prevail over interests of science and society.
4. The available nonclinical and clinical information on an investigational product should be
adequate to support the proposed clinical trial.
GCP PRINCIPLES
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Overview of ICH-GCP guidelines

15. 5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
6. A trial should be conducted in compliance with the protocol that has received prior
institutional review board (IRB)/independent ethics committee (IEC) approval/favorable
opinion.
7. The medical care given to, and medical decisions made on behalf of, subjects should always
be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
8. Each individual involved in conducting a trial should be qualified by education, training,
and experience to perform his or her respective task(s).
9. Freely given informed consent should be obtained from every subject prior to clinical trial
participation.
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Overview of ICH-GCP guidelines

16. 10. All clinical trial information should be recorded, handled, and stored in a way that
allows its accurate reporting, interpretation and verification.
11.The confidentiality of records that could identify subjects should be protected, respecting
the privacy and confidentiality rules in accordance with the applicable regulatory
requirement(s).
12.Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP). They should be used in accordance with
the approved protocol.
13.Systems with procedures that assure the quality of every aspect of the trial should be
implemented.
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Overview of ICH-GCP guidelines

17. ETHICS COMMITTEE RESPONSIBILITIES
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1. To protect the dignity, rights and well being of research participants.
2. To ensure that universal ethical values and international scientific standards are followed.
3. To assist in the development and the education of a research community responsive to
local health care requirements
• The researcher should submit an appropriate application to the IEC along with the study
protocol.
• The IEC should be able to provide complete and adequate review of the research
proposals submitted to them.
• All documentation and communication of an IEC are to be dated, filed and preserved
according to written procedures. Strict confidentiality is to be maintained.
Overview of ICH-GCP guidelines

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COMPOSITION
1. Chairperson
2. 1-2 basic medical scientists (preferably one pharmacologists).
3. 1-2 clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist / representative of non-governmental voluntary agency
6. One philosopher / ethicist
7. One lay person from the community
8. Member Secretary
Overview of ICH-GCP guidelines

19. SPONSOR RESPONSIBILITIES
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Quality assurance CRO Medical expertise
Trial design and
management
Investigator
selection
Financing
Investigational
products
Review
confirmation

20. INVESTIGATOR RESPONSIBILITIES
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Familiar with
investigational
products
Comply with GCP
& regulatory
requirements
Adequate resources
Medical care of the
trial subjects
Communication
with IRB/IEC
Compliance with
protocol
Investigational
product(s)
Randomization
procedures/
unblinding

21. CLINICAL TRIAL PROTOCOL
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General &
Background info
Objective Trial design
Selection &
Withdrawal of
subject
Treatment Safety assessment Quality control Record keeping

22. INVESTIGATORS BROCHURE
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The Investigator’s Brochure is a compilation of the
clinical and nonclinical data on the investigational
product(s) that are relevant to the study of the
product(s) in human subjects. Its purpose is to provide
the investigators and others involved in the trial with
the information to facilitate their understanding of the
rationale for, and their compliance with, many key
features of the protocol, such as the dose, dose
frequency/interval, methods of administration: and
safety monitoring procedures.

23. The PI discusses the trial’s risks, benefits and other aspects with the potential participant and,
if required, the participant’s legal representative, before the trial begins.
The PI gives the potential participant ample time and opportunity to ask questions about the
trial and discuss it with relatives and family members.
If the potential participant decides to get involved in the trial, he or she provides voluntary
consent by signing and dating the written informed consent document of which he or she also
receives a copy. The participant has the right to withdraw consent at any time without penalty,
repercussions or reason.
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INFORMED CONSENT PROCESS

24. Thank You
For your attention
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Any questions???
Overview of ICH-GCP guidelines