1. Good clinical practice (GCP) provides a standard to ensure clinical trials are scientifically valid and protect subject rights. GCP guidelines cover trial conduct, monitoring, records, and reporting. 2. Ethics committees review protocols to ensure trials are ethical and risks are outweighed by benefits. Investigators must be qualified and obtain informed consent. Sponsors design and fund trials and ensure product quality. 3. Clinical trial protocols describe trial objectives, methodology, and organization. Investigator brochures provide information on investigational products. Essential documents for GCP compliance include the protocol, consent forms, product information, records, and reports.

1. 22-12-2023
1
Presented By : Mr. Rahul Raut
F. Y. M. Pharm (Regulatory Affairs)
RCPIOP

2. Introduction
Sections
Principles
Ethics committee
Responsibilities of
sponsor, investigator,
and monitor
Investigator Brochure
Essential Documents
References
22-12-2023 2

3. What is
GCP?
22-12-2023 3

4. 22-12-2023 4
Recording
Documentation
monitoring

5.  Good clinical practice (GCP): A standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, and reporting of clinical trials that
provides assurance that the data and reported results are credible and accurate
and that the right, integrity, and confidentiality of trial subjects are protected.
 GCP ensure that the studies are scientifically authentic and that the clinical
properties of the investigational product are properly documented
GCP
Data &
Result
Ethics
= +
• Right
• Safety
• Well-being
• Credible
• Accurate
22-12-2023 5

6. To protect the right 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 humans, animal and material resources
To provide unified standard for the European union, Japan, and the
United State to facilitate the mutual acceptance of the clinical data
by the regulatory authorities in this jurisdictions
22-12-2023 6

7. • Glossary
1
• Principles of
GCP
2
• Requirements for
IRB/IEC
3
• Responsibilities
of the sponsor
4
22-12-2023 7

8. • Responsibilities
of the
investigator
5
• Clinical Trial
protocol
6
• Investigator’s
Brochure
7
• Essential
Documents
8
22-12-2023 8

9. Glossary
• Adverse Drug Reaction (ADR)
• An adverse event (AE)
• Audit
• Audit Certificate
• Audit Report
• Case Report Form (CRF)
• Clinical Trial/Study
• Comparator (Product)
• Compliance (in relation to trials)
22-12-2023 9
• Investigator's Brochure
• Monitoring
• Nonclinical Study
• Sponsor
• Standard Operating Procedures (SOPs)
• Monitoring Plan
• Good Clinical Practice (GCP)
• Compliance (in relation to trials)
• Confidentiality
• Contract Research Organization (CRO)
• Informed Consent
• Investigator

10. ICH GCP Principles
22-12-2023 10

11. 22-12-2023 11
Good clinical practice
Should be
conducted as per
Ethical
principles
Mention
as per
Consisted with
&
1

12. 22-12-2023 12
Before a trial is initiated
foreseeable risks and
inconveniences 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.
2

13. 22-12-2023 13
rights, safety, and well-being of
the trial subjects
Important
should prevail over
Interest of science &
society
3

14. 22-12-2023 14
The available
Nonclinical
&
clinical information
On
an investigational product
should be adequate
to support
4

15. 22-12-2023 15
scientifically sound, and described in a
clear, detailed protocol.
CLINICAL TRIALS
should be
5

16. 22-12-2023 16
should be conducted in
compliance with the
Received prior &
Approval from
6

17. 22-12-2023 17
Medical
Care
Given to
Trial subjects
Medical decisions made on behalf of
Should always be the
responsibility of a
Qualified physician or, qualified dentist.
7

18. 22-12-2023 18
Experience
Each individual involved
In conducting a trial
should be qualified by
To perform his or her respective task(s).
8

19. 22-12-2023 19
Trial subject
Freely given informed consent
Should be obtained
from every
prior to
Clinical Trial Participation.
9

20. 22-12-2023 20
Should be
Recorded
Handled
Stored
In a way that allows its
10

21. 22-12-2023 21
Trial subject
Regulatory
Requirements
The confidentiality
of record
that could identify
should be
Respecting the
In accordance
with the
applicable
11

22. 22-12-2023 22
Stored
In accordance with
applicable
Investigational
Product
Manufactured
Handled
Should
be
Should be used in
accordance with the
approved protocol.
12

23. 22-12-2023 23
Systems with procedures that assure the quality
of every aspect of the trial should be
implemented.
13

24. 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.
22-12-2023 24
ICH GCP Principles

25. 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/favourable 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).
22-12-2023 25
ICH GCP Principles

26. 9. Freely given informed consent should be obtained from every subject prior to
clinical trial participation.
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.
22-12-2023 26
ICH GCP Principles

27. Ethics committee Responsibilities
22-12-2023 27
Or
To protect
the dignity,
rights, and
well-being of
research
participants.
To ensure
that universal
ethical values
and
international
scientific
standards are
followed.
To Assist in
the
development
and education
of a research
community
responsive to
local
healthcare
requirement.
Review new
and revised
research
protocol.
Approved or
disapproved
of these
protocols.
Ensure that
informed
consent is
documented
if required.
Conduct a
continuing
review of
long-term
research
projects.

28. 1. Chairperson
2. 1-2 basic medical scientists (preferably one pharmacologist)
3. 1-2 clinicians from various institute
4. One legal expert
5. One social scientist/representative of a non-governmental voluntary agency
6. One philosopher/ethicist
7. One layperson from the community
8. Member secretary
22-12-2023 28

29. Sponsor Responsibilities
22-12-2023 29
Quality Assurance CRO Medical Expertise
Trial design &
management
Investigator
selection Financing
Investigational
product
Review
conformation by
IRB/IEC

30. 22-12-2023 30
Investigator Qualification & agreements
1
Adequate Resources
2
Medical Care of Trial Subject
3
Communication With IRB/IEC
4
Compliance with Protocol
5
Investigational Product
6
Randomization Procedure
7
Final Report by Investigator
13
Premature Termination of a Trials
12
Safety Reporting
11
Progress Report
10
Records & Reports
9
Informed consent of a Trial subject
8

31. Clinical Trial Protocol
• Trial protocols are documents that describe the objectives, design, methodology,
statistical considerations and aspects related to the organization of clinical trials.
Trial protocols provide the background and rationale for conducting a study,
highlighting specific research questions that are addressed, and taking into
consideration ethical issues. Trial protocols must meet a standard that adheres to
the principles of Good Clinical Practice, and are used to obtain ethics approval by
local Ethics Committees or Institutional Review Boards.
22-12-2023 31

32. Clinical Trial Protocol
22-12-2023 32
General
Information
Background
Information
Trial Subject &
Purpose
Trial Design
Selection &
withdrawal of
Subject
Treatment of
subject
Assessment of
Efficacy
Assessment of
Safety
Statistics
Direct access to
source
data/documents
Quality control &
Quality
Assurance
Ethics
Data handling &
record keeping
Financing &
Insurance
Publication
Policy
Supplements

33. Investigators Brochure
• The Investigator's Brochure (IB) 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
22-12-2023 33

34. 22-12-2023 34

35. Essential Documents
22-12-2023 35
• Investigator’s brochure
• Signed protocol and amendments, if any, and sample case report form (CRF)
• Information given to trial subject - informed consent form (including all applicable
translations)
• Advertisement for subject recruitment (if used)
• Financial aspects of the trial
• Insurance statement
• Signed agreement between involved parties, e.g.: - Investigator/institution and
sponsor, investigator/institution and CRO, sponsor and CRO,
investigator/institution and authority(ies) (where required)
• Institutional review board/independent ethics committee composition
• Regulatory authority(ies) authorization/approval/ notification of protocol (where
required)
• Curriculum vitae and/or other relevant documents evidencing qualifications of
investigator(s) and sub-investigator(s)
• Certificate(s) of analysis of investigational product(s) shipped
• Master randomisation list
• Clinical study report

36. References
• https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/
• https://www.slideshare.net/abelmathew5/ichgcp-guidelines
22-12-2023 36

37. 22-12-2023 37