This document outlines the Good Clinical Practice (GCP) guidelines geared towards ensuring the ethical and scientific quality in clinical trials involving human subjects in India. It emphasizes the protection of participant rights, integrity of biomedical data, and the need for comprehensive protocols, with a focus on establishing a unified standard for clinical research. The document includes various components such as ethical considerations, responsibilities of various stakeholders, and regulatory requirements that must be adhered to during clinical trials.

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Presented BY :- AKHILESH AKKI
1ST YEAR M PHARM
Dept. of Pharmaceutics,
Regulatory Affairs Group.
JSS COLLEGE OF PHARMACY MYSURU.

2. A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses and reporting of clinical trials that
provide assurance that the data and the reported results are
credible (able to be believed), accurate and that the rights,
integrity and confidentiality of trial subjects are protected.
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3.  GCP is an ethical and scientific quality standard for designing,
conducting and recording trials that involve participation of human
subjects.
 Formulated by expert committee set up by Central Drugs Standard
Control Organisation (CDSCO)
 Guidelines have been evolved with consideration of WHO, ICH, USFDA
and European GCP guidelines& Ethical Guidelines for Biomedical
Research on Human subjects issued by ICMR
 Primary Aim : To streamline(design) clinical studies in India
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4.  India offers unique opportunities for conducting Clinical trials in view
of
– Large patient pool
– Well trained enthusiastic investigators
– Premiere Medical institutes
– Considerable low per patient trial cost when compared to developed
countries
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5. The creation of GCP guidelines not only intended to protect the rights and
safety of the study subjects but was also intended to serve the interests of
all parties involved in the clinical research. The basic principles governing
the concept of GCP are as follows:-
 To assist, stimulate and achieve a unified standard, at a global level, for
the conduct of clinical research studies on human beings.
 To act as an educational tool for personnel interested in clinical research
or for clinicians already engaged in research, by furnishing the requisite
information with respect to the requirements of GCP and its efficient
implementation.
 Assist clinical research editors to assess the acceptability of the research
submitted for publication, and to enable regulatory personnel to
evaluate studies that may affect the use and registration of certain
medicinal products.
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6.  To provide a general summary and any other necessary advice on how
to apply and how to implement globally accepted GCP principles for
clinical research in human beings.
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7. 1. Definitions
2. Pre-requisites for the study
2.1 Investigational Product
2.2 Pre-Clinical Supporting data
2.3 Protocol
2.4 Ethical and safety considerations
2.4.1 Ethical Principles
2.4.2 Ethics Committee
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8. 2.4.3 Informed Consent Process
2.4.4 Essential Information on Confidentiality
2.4.5 Compensation for participation
2.4.6 Selection of Special groups as research Subjects
2.4.7 Compensation for accidental injury
3. Responsibilities
3.1 Sponsor
3.2 Monitor
3.4 Investigator
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9. 4. Record keeping & data handling
5. Quality Assurance
6. Statistics
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10.  Appendix I : Declaration of Helsinki
 Appendix II : Schedule Y
 Appendix III : Format for submission of pre- clinical and clinical data
for r-DNA based vaccines, diagnostics and other biologicals
 Appendix IV : Investigators Brochure
 Appendix V : Essential Documents
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11.  Ensure that studies are scientifically and ethically sound and the
clinical properties of the pharmaceutical substances under the
investigation are properly documented.
 The main two essential principles are
– Protection of the rights of human subjects
– Authenticity of biomedical data generated
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12. 2.1) Investigational Pharmaceutical Product: Physical, chemical,
pharmaceutical properties and the formulation of the Investigational
Product & Instructions for the storage and handling of the dosage form
must be documented. Any structural similarities to the other known
compounds should be mentioned.
2.2) Pre-clinical supporting data , available pre-clinical data and clinical
information on the Investigational Product should be adequate and
convincing to support the proposed study.
2.3) Protocol well-structured and complete protocol.
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13. 1. General Information Protocol title, protocol identifying
number and date.
a) Name, address & contact numbers of the sponsor and the monitor /
CRO (Clinical research organisation)
b) Name and title of the persons authorised to sign the protocol
c) Name, title, address and contact numbers of the sponsor's medical
expert for the study
d) Name(s), title(s), address(es) and contact numbers of the
investigator(s)
e) Name(s), address(es) and contact numbers of the institution(s) -
clinical laboratories
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14. 2. Objectives and Justification
a) Aims and objectives of the study,
b) Name and description of the investigational product
c) A summary of findings from non-clinical studies
d) Summary of the known and potential risks and benefits, if any, to
human subjects.
3. Ethical Considerations
a) General ethical considerations related to the study
b) How patients / healthy volunteers will be informed and how their
consent will be obtained
c) Possible reasons for not seeking informed consent
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15. 4. Study design
a) Primary and secondary end points, if any, to be measured during the
study
b) Description of the type of the study
c) Schematic diagram of the study design, procedures and stages
d) Medications/treatments permitted and not permitted
e) Duration of the subject participation and proposed date of initiation
of the study
f) Discontinuation criteria for study subjects
g) Procedures for monitoring subjects’ compliance
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16. 5. Inclusion, Exclusion and Withdrawal of Subjects
a) Includes subject inclusion criteria, Exclusion criteria, withdrawal
criteria
6. Handling of the Products
7. Assessment of Efficacy
a) Description of how effects are measured and recorded and Time and
periodicity of effect recording
8. Assessment of Safety
9. Statistics
10. Data handling and management
a) Persons having direct access to source data / documents
b) Procedures for handling and processing records of adverse events
to the products
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17. c) Procedures for the keeping of patient lists and patient records
11. Quality control and quality assurance
12. Finance and insurance
a) Mention all financial aspects of conducting and reporting a study
13. Publication policy
14. Evaluation
a) specified account for how the response is to be evaluated including
methods of computation and calculation of effects.
b) Description of how to deal with and report subjects withdrawn from
the study
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18.  Documents to be provided with protocol
– Information to the Study Subjects
– Instructions to staff
– Descriptions of special procedures
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19. 2.4) Ethical & Safety Considerations
2.4.1) Ethical principles
a) Principles of essentiality : research entailing the use of human
subjects is absolutely essential for the advancement of knowledge
and for the benefit of all members of the human species after the
proposed research is dully vetted and consideration of all other
alternatives
b) Principles of voluntariness, informed consent and community
agreement
c) Principles of non-exploitation : subjects should be remunerated
and apart from the socio economic status, should be well informed
about the study
d) Principles of privacy and confidentiality : no details of subjects
identity should be disclosed without valid scientific and legal reasons
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20. e) Principles of precaution and risk minimisation : research designed
in such a way that subjects are put to the minimum risk, suffer &
generally benefit from the research
f) Principles of professional competence : should be conducted by
professionally qualified people
g) Principles of accountability and transparency : research conducted
in honest, impartial & transparent manner
h) Principles of the maximisation of the public interest and of
distributive justice
i) Principles of institutional arrangements
j) Principles of public domain
k) Principles of totality of responsibility
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21.  Responsibilities
– Dignity, rights & well being of research participants
– Ensure that universal ethical values & international scientific
standards are expressed in terms of local community values & customs
– Assist in development & the education of a research community
 Composition
– Should be multidisciplinary & multi sectorial
– 5-7 members, maximum of 12-15
– Chairperson from outside the institution
– Composition as follows
– Chairperson – 1-2 basic medical scientist ( one pharmacologist)
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22. – 1-2 Clinicians from various institutes
– One legal expert or retired judge
– One social scientist
– One Philosopher
– One lay person
– Member Secretary
– Adequate representation of age, gender & community
 Record Retention
– At least 5 years after the completion or termination of study if it is
not possible to maintain the same permanently
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23.  Sponsor
1. Investigator/Institution Selection
2. Allocation of duties & responsibilities
3. Study management, data handling and record keeping
4. Compensation for participation
5. Confirmation of review by the ethics committee
6. Information on Investigational products
7. Supply, storage and handling of Pharmaceutical products
8. ADR reporting
9. Study Reports
10. Monitoring& Audits
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24.  Should be qualified enough by education, training & experience for
proper conduct of study & should have qualifications prescribed by
Medical Council of India (MCI).
 His main responsibilities include:-
a) Medical care of study subjects
b) Monitoring and auditing of records
c) Communication with EC (ethical comities)
d) Conduct study in accordance with protocol
e) Selection and recruitment of study subjects
f) Accuracy and completeness of records and reports
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25.  The basic concept of record-keeping and handling of data is to
record, store, transfer, and where necessary convert efficiently and
accurately the information collected on the trial subjects into data
that can be used to compile the Study Report.
1) Documentation
2) Corrections
3) Electronic Data Processing
4) Validation of Electronic Data Processing Systems
5) Language
6) Responsibilities of the Investigator
7) Responsibilities of the Sponsor and the Monitor
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26.  Prior to the Subject’s participation in the Study the written Informed
Consent form should be signed and personally dated by
subject/Impartial witness & the Investigator
 Essential information that must be provided to the subject should
contain:-
1. Aims & methods of research
2. Expected duration
3. Reasonably expected benefits
4. Alternative procedures if any
5. Foreseeable risks
6. Right of prevent use of his/her biological samples
7. Extend of confidentiality of the subjects
8. Free treatment to research related injury
9. Compensation
10. Voluntary participation
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27. 1) Role of a Biostatistician Involvement of a appropriately qualified and
experienced statistician is necessary in the planning stage as well as
throughout the Study. The Bio-statistician’s should make a statistical
model to help the Sponsor, CRO and / or the Investigator in writing
the Protocol. The number of Subjects to be included in the study is
determined in relation to the statistical model on which the Protocol
is based.
2) Study Design
 Randomisation and blinding
 Statistical Analysis
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28. Appendix I
 WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
 Ethical Principles for Medical Research Involving Human Subjects :
 It includes:
A. INTRODUCTION
B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
MEDICAL CARE
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29. Appendix II
 SCHEDULE Y
 Requirements and guidelines on clinical trials for import and
manufacture of new drug
1. Clinical Trials
2. Chemical and Pharmaceutical Information
3. Animal Toxicology
4. Animal Pharmacology
5. Human/Clinical Pharmacology trials (Phase I)
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30. 6. Exploratory trials (Phase II)
7. Confirmatory trials (Phase III)
8. Special Studies
9. Submission of Reports (Appendix II to Schedule Y)
10. Regulatory status in other counties
11. Marketing Information
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31. Appendix I to Schedule Y
 Data required to be submitted with application for permission to
market a new drug.
1. Introduction
2. Chemical and pharmaceutical information
3. Animal pharmacology
4. Animal toxicology (See Appendix III and IV to Sch. Y)
5. Human/clinical pharmacology (Phase I)
6. Exploratory clinical trials (Phase II)
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32. 7. Confirmatory clinical trials (Phase III)
8. Special studies
9. Regulatory status in other countries
10. Marketing information
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33. APPENDIX III to Schedule Y
 Animal toxicity requirements for clinical trials and
marketing of a new drug
APPENDIX IV to Schedule Y
 Number of animals for long term toxicity studies
APPENDIX V to Schedule Y
 Patient consent form for participation in a Phase I Clinical
Trial
APPENDIX VI to Schedule Y
 Data requirements of Fixed Dose Combinations
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34. APPENDIX III
 Format for submission of preclinical and clinical data
 For r-DNA based vaccines, diagnostics and other biologicals.
A. SPECIFICATION AND CHARACTERIZATION INFORMATION ON R-
DNA VACCINES AND BIOLOGICAL PRODUCTS.
a) Description in details of the method of r-DNA products
b) Description of the method of sequence verification
c) Description on Identity-Physical, Chemical, Immunological and
Biological wherever applicable.
d) Potency.
e) General Safety Test.
f) Data on sterility tests as per Indian Pharmacopeia guidelines.
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35.  f) Data on purity of recombinant product.
 g) Description of constituent materials like preservatives etc.
 h) Data on stability of finished formulation as per IP (Indian
pharmacopeia) guidelines.
B. DATA ON PRECLINICAL TESTING
1. Biological activity/ pharmacodynamics in vitro and in appropriate
animal models.
2. Safety Pharmacology (Functional indices of toxicity).
3. Toxicology and pharmacokinetics (Absorption, Distribution,
Metabolism, Excretion ADME)
4. Immunogenicity/Immunotoxicity
5. Reproductive and developmental toxicity
6. Genotoxicity studies
7. Carcinogenicity studies
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36. C: RECOMBINANT IMMUNODIAGNOSTIC REAGENTS
D: CLINICAL TRIALS
1. Phase I : Human/Clinical Pharmacology Immunogenic Potency
2. Phase II: Exploratory Clinical Trials- Preventive/Therapeutic Efficacy
(Data to be generated in subjects residing in endemic/ non-endemic
areas)
3. Phase III: Confirmatory Trials
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37. APPENDIX IV
 INVESTIGATOR’S BROCHURE (IB)
APPENDIX V
 ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL
TRIAL
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38.  https://www.researchgate.net/publication/327209215_Good_
Clinical_Practices_An_Indian_Perspective
 https://www.iddresearch.com/wp-
content/uploads/2018/06/Indian_GCP_Guidelines.pdf
 http://www.sgpgi.ac.in/sop/GCP-%20Indian.pdf
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