The document outlines the ICH GCP E6 guidelines, which serve as a standard for the conduct of clinical trials to ensure data credibility and protect trial subjects' rights. It details the core principles, responsibilities of sponsors and investigators, the informed consent process, and essential documentation required for compliance. Adhering to these guidelines is crucial for maintaining the integrity and ethical standards of clinical research involving human participants.

1. Good Clinical
Practice
Guidelines
ICH GCP E6
DATE OF PRESENTATION : 30-04-2024
ROSFEENA JOSEPH
1ST SEMESTER
MPHARM REGULATORY AFFAIRS
CHEMISTS COLLEGE OF PHARMACEUTICAL SCIENCES
AND RESEARCH

2. OUTLINE
• Introduction
• Objectives
• Sections
• Principles
• Ethics committee
• Responsibilities of Sponsor, Investigator and Monitor
• Clinical Trial Protocol
• Investigators Brochure
• Informed Consent process
• Essential documents
• Conclusion

3. INTRODUCTION
Good clinical practice (GCP)
It is 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.
ICH-GCP is an International Conference on
Harmonization Good Clinical Practice.
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

4. OBJECTIVES
• To protect the rights of human subjects participating in
clinical trials
• To ensure the scientific validity and credibility of the data
collected in human clinical studies.
• More economical use of human, animal and material
resources.
• 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
.

5. ICH GCP E6
• The 1st guideline for good clinical practice (ICH E6 R1) was
published in 1996.
• The guidelines are very detailed and categorized in several
sections.
• There are 13 core principles for ICH GCP.
• It ensures the safety, rights and wellbeing.
• Integrated addendum to ICH E6(R1):guideline for good
clinical practice E6(R2) was published on 2016.
• ICH Harmonized guideline good clinical practice (GCP)
E6(R3) was published on may 2023.
• R3 is the latest revision of ICH E6.

6. 8 Sections of ICH-GCP Guidelines
------------------------------------------------------------------------------------------------
1. Glossary
2. Principles of GCP
3. Requirements for IRB IEC
4. Responsibilities of Sponsor
5. Responsibilities of Investigator
6. Clinical trail protocol
7. Investigators brochure
8. Essential documents

7. 13 PRINCIPLES OF GCP
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.

8. 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.

9. 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.

10. ETHICS COMMITTEE
RESPONSIBILITIES
_____________________________________________________________
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.

11. COMPOSITION
• Chairperson
• 1-2 basic medical scientists (preferably one pharmacologists).
• 1-2 clinicians from various Institutes
• One legal expert or retired judge
• One social scientist / representative of non-governmental voluntary
agency
• One philosopher / ethicist
• One lay person from the community
• Member Secretary

12. SPONSOR
• A sponsor in literal terms is defined as an individual or a
company or an institution that takes the responsibility for
the initiation, management and/or financing of a clinical
study.
• In case an investigator independently initiates and takes
full responsibility for a trial, he/she automatically
assumes the role of a sponsor.

13. SPONSOR
RESPONSIBILITIES
_____________________________________________________________
• Quality Management
• Critical Process and Data Identification
• Risk Evaluation, Identification, and Control
• Risk Communication, Review and Reporting
• Quality Assurance and Quality Control
• Contract Research Organization (CRO)
• Medical Expertise
• Trial Design
• Trial Management, Data Handling, and Record Keeping
• Investigator Selection
• Allocation of Responsibilities
• Compensation to Subjects and Investigators

14. • Financing
• Notification/Submission to Regulatory Authority
• Confirmation of Review by IRB/IEC
• Information on Investigational Product
• Manufacturing, Packaging, Labelling, and Coding Investigational
Product
• Supplying and Handling Investigational Product
• Record Access
• Safety Information
• Adverse Drug Reaction Reporting
• Monitoring
• Audit
• Noncompliance
• Premature Termination or Suspension of a Trial
• Clinical Trial/Study Reports

15. INVESTIGATOR
• Investigator: A person responsible for the conduct of the
study at the trial site.
• Investigator is a person responsible for the rights, health
and welfare of the study subjects.
• Principal investigator: In case the study is conducted by
a team of investigators at one site or at multiple sites,
then the investigator who coordinates between the
different investigators involved in the study is termed as
the Principal investigator.

16. Investigator responsibilities
______________________________________________________________
Familiar with
investigational
products
Comply with
GCP &
regulatory
requirements
Medical care of
the trial
subjects
Communication
with IRB/IEC
Compliance
with
protocol
Investigational
product

17. Investigator's Qualifications and
Agreements
• The investigator should be qualified by education,
training, and experience to assume responsibility for the
proper conduct of the trial, should meet all the
qualifications specified by the applicable regulatory
requirement, and should provide evidence of such
qualifications through up-to-date curriculum vitae and
other relevant documentation requested by the sponsor,
the IRB/IEC, and the regulatory authority.
• The investigator should be thoroughly familiar with the
appropriate use of the investigational product, as
described in the protocol, in the current Investigator's
Brochure, in the product information and in other
information sources provided by the sponsor.

19. CLINICAL TRIAL PROTOCOL
• The protocol is a document that describes how a clinical
trial will be conducted (the objectives, design,
methodology, statistical considerations and organization
of a clinical trial,) and ensures the safety of the trial
subjects and integrity of the data collected.
• A protocol is the precise and detailed design for
conducting a research study; specifically, it is the study
plan submitted to an IRB for review.

20. AIMS OF PROTOCOL
1. To raise the question to be researched and clarify its importance.
2. To collect existing knowledge and discuss the efforts of other
researchers who have worked on the related questions (Literature
review).
3. To formulate a hypothesis and objectives.
4. To clarify ethical considerations.
5. To suggest the methodology required for solving the question and
achieving the objectives.
6. To discuss the requirements and limitations in achieving the
objectives.

21. KEY BENEFITS

22. Main contents
General &
Background info
Objective Trial design
Selection and
Exclusion of Subjects
Treatment Safety assessment
Assessment of
Efficacy
Adverse Events
Discontinuation of
the Study
Statistics
Quality Control and
Assurance
Ethics
Data handling and
Recordkeeping
Publication Policy
Project
Timetable/Flowchart
References

23. INVESTIGATORS BROCHURE
• An Investigator’s Brochure is a collection of clinical and
non-clinical data about the investigational products that
are the focus of the study. The brochure should provide
an ongoing insight into the clinical trial study participants
during the duration of the trial.
• The purpose of an Investigator’s Brochure is to provide
Investigators and other crucial people involved in the trial
with enough information to help their understanding of
the reasons for and compliance with the key features of a
clinical trial protocol including dose, dose frequency,
methods of administration and safety monitoring
procedures.
.

24. INFORMED CONSENT
______________________________________________________________
• A process in which patients are given important
information, including possible risks and benefits, about a
medical procedure or treatment, genetic testing, or a
clinical trial. This is to help them decide if they want to
be treated, tested, or take part in the trial.
• Informed consent is crucial in research as it ensures
individuals have an informed choice about whether to
participate in a research study.

25. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF
A CLINICAL TRIAL
• Essential Documents are those documents which individually and collectively
permit evaluation of the conduct of a trial and the quality of the data
produced. These documents serve to demonstrate the compliance of the
investigator, sponsor and monitor with the standards of Good Clinical
Practice and with all applicable regulatory requirements.
• The various documents are grouped in three sections according to the stage
of the trial during which they will normally be generated:
Before the clinical phase of the trial commences
During the clinical conduct of the trial
After completion or termination of the trial

26. Before the clinical phase of the trial
commences
• INVESTIGATOR'S BROCHURE
• SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT
FORM (CRF)
• INFORMATION GIVEN TO TRIAL SUBJECT-INFORMED CONSENT FORM
• FINANCIAL ASPECTS OF THE TRIAL
• INSURANCE STATEMENT (where required)
• SIGNED AGREEMENT BETWEEN INVOLVED PARTIES,
e.g.:- investigator/institution and sponsor
• DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL
REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC)
• INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE
COMPOSITION

27. Documents generated during the clinical
conduct of the trial
• INVESTIGATOR'S BROCHURE UPDATES
• ANY REVISION TO:
• protocol/amendment and CRF
• informed consent form
- any other written information provided to subjects
- advertisement for subject recruitment
• DATED, DOCUMENTED APPROVAL / FAVOURABLE OPINION OF INSTITUTIONAL
REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
• Protocol amendment
• Revision of:
• Informed consent form
• Any other written information to be provided to the subject advertisement for subject
recruitment
• Any other documents given approval/favorable opinion
• Continuing review of trial
• REGULATORY AUTHORITY AUTHORISATIONS / APPROVALS / NOTIFICATIONS
• CURRICULUM VITAE FOR NEW INVESTIGATOR AND/OR SUB-INVESTIGATOR

28. Documents generated after termination of
clinical trial
• • Investigational product accountability at site
• • Documentation of investigational product destruction
• • Completed subject identification code list
• • Audit certificate
• • Final trial close-out monitoring report
• • Treatment allocation and decoding documentation
• • Final report by investigator to irb/iec where required, and where
applicable, to the regulatory authority
• • Clinical study report

29. CONCLUSION
Good Clinical Practice (GCP) is an international, ethical, scientific and
quality standard for the conduct of trials that involve human
participants. ICH GCP E6 is a comprehensive document, and it's
essential for all parties involved in clinical trials, including investigators,
sponsors, and regulatory authorities, to be familiar with its principles
and guidelines. Adherence to ICH GCP E6 helps ensure the integrity,
reliability, and ethical conduct of clinical trials, ultimately contributing to
the safety and well-being of study participants and the validity of trial
results.
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30. REFERENCES
 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-
guideline-good-clinical-practice_en.pdf
 https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1
 https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideli
ne_2023_0519.pdf
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31. THANKYOU