Good Clinical Practice (GCP) guidelines provide standards for conducting clinical trials involving human subjects. The history of GCP includes events like the Nuremberg Code (1949), Declaration of Helsinki (1964), and ICH guidelines (1990-1997) that were developed in response to ethical issues in clinical research. The ICH GCP guideline has 8 sections covering topics like investigator responsibilities, informed consent, and essential trial documents. GCP aims to protect subject rights and safety while ensuring reliable trial data.

1. Good Clinical
Practice
Presented by: Dr Nilamjyoti Medhi
PGT, Dept of Pharmacology
Moderator: Dr Rituparna P Ray
Associate Professor

2. Objectives
What is GCP
The history of Good Clinical Practices
Guidelines for GCP
Basic principles

3. Definition
 A standard for the
Design Auditing
Recording Conduct
Analyses Performance
Reporting Monitoring
of clinical trials that provide assurance that the data and the
reported results are CREDIBLE, ACCURATE and that the
RIGHTS, INTEGRITY and CONFIDENTIALITY of trial
subjects are protected.

4. The history…
– Public disasters, serious fraud and abuse of human rights.
– Trials of War criminals --Nuremberg code 1949
– Thalidomide -- Declaration of Helsinki 1964
– Belmont report 1978
– ICH 1990

5. How ICH started..
– 1st conf. in 1990 in Brussels
– 3 regions participated  EU / United States / Japan
– Representatives from  Industry/ Academia/ Ministry of
health.
– WHO, EFTA and Canada observers
– Reduce duplication
– Efficiency , registration for new pharmaceuticals

6. ICH resulted in...
Many guidelines made
– Most important- ICH GCP guidelines
– Evolved in several steps
– Consolidated guideline ICH E6 Sept 1997

7. Role of ICH
– Safeguard public health
– Assure consumer protection standards
– Facilitate availability of safe and effective products
– Eliminate inconsistent standards internationally
– Facilitate mutual acceptance of data from clinical trials

8. ICH GCP guideline..
8 sections

9. Sections..
1. Glossary
2. Principles of Good Clinical Practice
3. Requirements for IRB/IEC
4. Responsibilities of the investigator
5. Responsibilities of the sponsor
6. Requirements for clinical trial protocol and protocol amendments
7. Responsibility of the sponsor in the development of investigator’s
brochure
8. Essential documents.

10. 1. Glossary
 62 points
 Common language for investigators/sponsors/ethics
committees
1. Adverse Drug Reaction (ADR)
2. Audit
3. Case Report Form (CRF)
4. Contract Research Organization (CRO)
5. Independent Ethics Committee (IEC)

11. 2. GCP Principles…
1. The ethical principles
2. Risk and benefits.
3. The rights, safety, and well-being
4. Supportive data
5. Protocol
6. Ethical clearance.
7. Subject care
8. Qualified staff

12. GCP Principles…
9. Informed consent
10.Data
11.Confidentiality
12.Investigational Product
13.Quality of procedures.

13. 3. Requirements for IRB/IEC
– Responsibilities
– Composition, Functions and Operations
– Procedures
– Records

14. 4. Responsibilities of the investigator
 Investigator's Qualifications and Agreements
 Adequate Resources
 Medical Care of Trial Subjects
 Communication with IRB/IEC
 Compliance with Protocol
 Investigational Product(s)
 Randomization Procedures and Unblinding
 Informed Consent of Trial Subjects

15. 5. Responsibilities of the sponsor
 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

16. 6. Clinical trial protocol and protocol
amendment(s)
 General Information
 Background Information
 Trial Objectives and Purpose
 Trial Design
 Selection and Withdrawal of Subjects
 Treatment of Subjects
 Assessment of Efficacy
 Assessment of Safety

17. 7. Investigator’s brochure
 Introduction
 General Considerations
 Contents of the Investigator’s Brochure

18. 8. Essential documents..
 Before the Clinical Phase of the Trial Commences
 During the Clinical Conduct of the Trial
 After Completion or Termination of the Trial

19. Indian GCP guidelines..
– Released in Dec 2001(Developed by CDSCO and endorsed
by DCGI)
– Has Revised Schedule Y (Jan 2005) addressed
discrepancies?

20. Issues in Developing Countries
– The informed consent process
– Economic Vulnerability
– Patient doctor relationship
– Education level

21. STAKEHOLDERS & THEIR
RELATIONSHIPS
SUBJECT
REGULATORY
AUTHORITY
SPONSOR
ETHICS
COMMITTEE
INVESTIGATOR

23. Declaration of Helsinki - 1964
– Developed to guide physicians in biochemical research involving human
subjects
– Requires:
o All physicians to conform to accepted scientific principles
o A research protocol to be reviewed by an independent committee
o Research performed by “clinically competent person”
o Objective proportional to risk
o Rights of patients protected
o Participants to be fully informed, and to consent to take part

24. Cont…
– 1962 US FDA IND Guidelines
– 1964 Declaration of Helsinki
– 1968 Committee on Safety of Medicines, UK
– 1978 GCP, US FDA
– 1991 GCP, Europe
– 1996 ICH GCP
– 1997 ICH GCP Guideline

25. Nuremberg code 1949..
– Nuremberg, Germany
– October 1946–April 1949 – trial of the World War II
– Nuremberg Military Tribunals
– Control Council Law No. 10

26. code 1949..
1. The voluntary consent of the human subject is absolutely
essential.
2. The experiment should be such as to yield fruitful results for the
good of society, unprocurable by other methods or means of
study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results
of animal experimentation
4. The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori
reason to believe that death or disabling injury will occur.

27. code 1949..
6. The degree of risk to be taken should never exceed that determined by
the humanitarian importance of the problem to be solved by the
experiment
7. Proper preparations should be made and adequate facilities provided to
protect the experimental subject against even remote possibilities of
injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified
persons
9. During the course of the experiment the human subject should be at
liberty to bring the experiment to an end
10. During the course of the experiment the scientist in charge must be
prepared to terminate the experiment at any stage

28. Belmont report 1978...

29. Cont...
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 tasks
9 Freely given informed consent should be obtained from every subject
prior to clinical trial participation

30. Cont...
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 requirements
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

31. Role of GCP
– Good clinical practice (GCP) is an international ethical &
scientific standard for conducting clinical trials that involve
the participation of human subjects
– Compliance with this standard provides public assurance
that the rights, safety & well-being of trial subjects are
protected, which is consistent with the principles outlined in
the declaration of Helsinki
– GCP also ensures the credibility of clinical trial data.