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INDIAN GCP GUIDELINE
PRESENTED BY:
Shrawan Kumar
2308212170011
M.PHARM 1Stsem (RA)
TABLE OF CONTENT
INTRODUCTION
GCP PRINCIPLE
INDEPENDENT ETHICS COMMITTEE
INFORM CONSENT PROCESS
RESPONSIBILITIES(SPONSOR, MONITOR, INVESTIGATOR)
STATISTICS
SPECIAL CONCERNS
CLINICAL TRIAL PROTOCOL
INVESTIGATOR’S BROCHURE
SCHEDULE Y
COMPARISON OF ICH GCP AND INDIAN GCP 2
INTRODUCTION
What is GCP?
Good Clinical Practice is a set of guidelines for biomedical studies
which encompasses the design, conduct, termination, audit, analysis,
reporting and documentation of the studies involving human subjects
Its aim is to ensure that the studies are scientifically and ethically
sound and that the clinical properties of the pharmaceutical substances
under investigation are properly documented.
3
The guidelines seek to establish two cardinal principles:
These guidelines have been evolved with consideration of WHO,
ICH, USFDA and European GCP guidelines as well as the Ethical
Guidelines for Biomedical research on Human Subjects issued by the
Indian Council of Medical Research.
Protection of the rights of
human subjects
Authenticity of biomedical
data generated
4
INTRODUCTION
All research involving human subjects should be conducted in
accordance with the ethical principles contained in the current
revision of Declaration of Helsinki.
The following principles are to be followed:
1. Principles of essentiality.
2. Principles of voluntariness, informed consent and community
agreement.
3. Principles of non-exploitation.
4. Principles of privacy and confidentiality.
5. Principles of precaution and risk minimization.
GCP PRINCIPLES:
5
6.Principles of professional competence.
7.Principles of accountability and transparency.
8.Principles of the maximization of the public interest and of
distributive justice.
9.Principles of institutional arrangements.
10.Principles of public domain.
11.Principles of totality of responsibility.
12.Principles of compliance.
6
GCP PRINCIPLES:
INDEPENDENT ETHICS COMMITTEE:
An Independent committee comprising of medical / scientific and
non-medical / non-scientific members, whose responsibility is to
verify the protection of dignity, rights, safety and well-being of
human subjects involved in a study.
7
Composition of IEC:
IEC should be multidisciplinary and multi-sectorial in composition. The
composition may be as follows :-
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 / theologian
7.One lay person from the community
8.Member Secretary 8
Responsibility of IEC:
IEC ensure a competent review of all ethical aspects of the project
proposals received.
To protect the dignity, rights and well being of the potential research
participants.
To ensure that universal ethical values and international scientific
standards are expressed in terms of local community values and
customs.
To assist in the development and the education of a research
community responsive to local health care requirements.
9
The Ethics Committee should review every research proposal on
human subjects.
The Committee should evaluate the possible risks to the subjects with
proper justification.
The ethical review should be done through formal meetings and
should not resort to decisions through circulation of proposals.
Ensuring that the IEC promptly notify in writing the investigator/
institution concerning :
a) Its trial related decisions/ opinions .
b) The reasons for its decisions/ opinions .
c) Procedures for appeal of its decisions/ opinions .
10
Responsibility of IEC:
All documentation and communication of an IEC are to be dated,
filed and preserved according to written procedures. Strict
confidentiality is to be maintained during access and retrieval
procedures. Records should be maintained for the following :
1.The curriculum vitae of all IEC members.
2.Standing operating procedures of the IEC.
3.National and international guidelines.
It is recommended that all records must be safely maintained after the
completion / termination of the study for at least a period of 5 years
11
Responsibility of IEC:
Informed Consent Process:
Informed consent is a process by which a subject voluntary
confirms his/her willingness to participate in one or another
clinical trial. And only after having been informed of all aspects
of the study Informed consent should be documented by means
of a written, signed and dated Informed Consent Form (ICF).
12
Informed Consent of Subject :
Prior to the beginning of the Study the Investigator(s) should obtain
the Ethics Committee’s approval for the written informed consent
form and all information being provided to the Subjects and / or their
legal representatives or guardians.
The information should be given to the Subjects and / or their legal
representatives or guardians in a language and at a level of complexity
that is understandable to the Subject(s) in both written and oral form
The Investigator(s), Sponsor or staff of the Institution should not
coerce or unduly influence a potential Subject to participate or to
continue to participate in the Study
13
Prior to the Subject’s participation in the Study the written Informed
Consent form should be signed and personally dated by
(i) The Subject
(ii) Subject’s legal representative or guardian or
(iii)An impartial witness
(iv) The Investigator
14
Informed Consent of Subject :
Content of Inform consent
Essential information that must be provided to the subject should
contain
1) Aims and methods of research
2) Expected duration
3) Reasonable expected benefits
4) Alternative Procedure if any
5) Foreseeable risks
6) Free treatment to research related injury
15
7) Compensation
8) Voluntary participation
9) Phone no and address of the contact persons
10)All information about the biological material and data generated
from the person
11)Risk of discovery of biological sensitive information
16
Content of Inform consent
Compensation for Participation:
All payments, reimbursement and medical services to be provided to
research subjects should be approved by the IEC. Care should be
taken:
1) when a subject is withdrawn from research for medical reasons
related to the study the subject should get the benefit for full
participation;
2) Then a subject withdraws for any other reasons he/she should be
paid in proportion to the amount of participation.
17
Compensation for Accidental Injury
Research subjects who suffer physical injury as a result of their
participation in the Clinical Trial are entitled to financial or other
assistance to compensate them equitably for any temporary or
permanent impairment or disability subject to confirmation from IEC
In case of death, their dependents are entitled to material
compensation
18
Selection of Special Groups As Research Subject
1) Pregnant or nursing women:
Pregnant or nursing women should in no circumstances be the subject
of any research unless the research carries no more than minimal risk
to the fetus or nursing infant and the object of the research is to obtain
new knowledge about the foetus, pregnancy and lactation
19
2) Children:
• The purpose of the research is to obtain knowledge relevant to health
needs of children. For clinical evaluation of a new drug the study in
children should always be carried out after the phase III clinical trials
in adults.
• A parent or legal guardian of each child has given proxy consent.
• The assent of the child should be obtained
• The child's refusal to participate in research must always be respected
unless there is no medically acceptable alternative to the therapy
provided/tested, provided the consent has been obtained from
parents/guardian;
Selection of Special Groups As Research Subject
20
3) Vulnerable group:
• Effort may be made to ensure that individuals or communities invited
for research be selected in such a way that the burdens and benefits of
the research are equally distributed.
• Rights and welfare of mentally challenged and mentally differently
able persons who are incapable of giving informed consent or those
with behavioral disorders must be protected.
• Adequate justification is required for the involvement of subjects such
as prisoners, students, subordinates, employees, service personnel etc.
who have reduced autonomy as research subjects.
Selection of Special Groups As Research Subject
21
SPONSOR:
An individual, company, institution, or organization that takes
responsibility for the initiation, management, and financing of a
clinical trial.
22
Quality Assurance and Quality Control: The sponsor is
responsible for implementing and maintaining quality assurance and
quality control systems with written SOPs
Contract Research Organization (CRO):
A sponsor may transfer any or all of the sponsor's trial-related duties
and functions to a CRO.
Trial Design: The sponsor should utilize qualified individuals (e.g.,
biostatisticians, clinical pharmacologists, and physicians) as
appropriate.
Medical Expertise :The sponsor should designate appropriately
qualified medical personnel who will be readily available to advise on
trial-related medical questions or problems.
Responsibilities(Sponsor):
23
Trial Management, Data Handling, and Recordkeeping:
 The sponsor should utilize appropriately qualified individuals to
supervise the overall conduct of the trial, to handle the data, to verify
the data, to conduct the statistical analyses, and to prepare the trial
reports.
 The sponsor should use an unambiguous subject identification code
that allows identification of all the data reported for each subject.
 The sponsor is responsible for selecting the investigator(s).
 The sponsor should obtain the investigator's/institution's agreement:
 To conduct the trial in compliance with GCP,
Responsibilities(Sponsor):
24
Responsibilities(Sponsor):
 To comply with procedures for data recording/reporting,
 To permit monitoring, auditing, and inspection
Compensation to Subjects and Investigators:
 The sponsor should provide insurance.
 The sponsor's policies and procedures should address the costs of
treatment of trial subjects in the event of trial-related injuries in
accordance with the applicable regulatory requirement(s)
Financing:
 The financial aspects of the trial should be documented in an
agreement between the sponsor and the investigator.
25
Confirmation of review by the Ethics Committee:
 An undertaking that the Ethics Committee is organized and operates
according to the GCP and the applicable laws and regulations
Information on Investigational Product(s):
 When planning trials, the sponsor should ensure that sufficient safety
and efficacy data from nonclinical studies and/or clinical trials are
available to support human exposure by the route, at the dosages, for
the duration, and in the trial population to be studied.
Adverse Drug Reaction Reporting:
 The Sponsor should provide ADR / AE reporting forms to the
Investigator(s) / Institution(s).
Responsibilities(Sponsor):
26
Audit:
 Sponsor should perform an audit as a part of QA system. This audit
should be conducted with the purpose of being independent and
separate from routine monitoring or quality control functions.
Notification/Submission to Regulatory Authority:
 Before initiating the clinical trial, the sponsor should submit any
required application(s) to the appropriate authority for review,
acceptance, and permission (as required by the applicable regulatory
requirement(s)) to begin the trial(s).
 Any notification/submission should be dated and contain sufficient
information to identify the protocol.
Responsibilities(Sponsor):
27
Manufacturing, Packaging, Labeling, and Coding Investigational
Product(s):
 The sponsor should ensure that the investigational product(s) is
characterized as appropriate to the stage of development of the
product(s), is manufactured in accordance with any applicable GMP.
 The labeling should comply with applicable regulatory
requirement(s).
 The sponsor should determine, for the investigational product(s),
acceptable storage temperatures, storage conditions, storage time.
Responsibilities(Sponsor):
28
A person appointed by the Sponsor or Contract Research
Organization (CRO) for monitoring and reporting the progress of the
trial and for verification of data.
The monitor ensures that the trial is conducted, recorded and reported
in accordance with the Protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP) and the applicable regulatory
requirements.
MONITOR:
29
Selection and Qualifications of Monitors:
Monitor should be appointed by the Sponsor or Contract Research
Organization (CRO).
The monitor should have adequate medical, pharmaceutical and / or
scientific qualifications and clinical trial experience. A monitor's
qualifications should be documented.
Monitor should be fully aware of all the aspects of the product under
investigation, protocol, written informed consent form and any other
written information to be provided to subjects.
30
The main responsibility of the monitor is to oversee the progress of
the study.
Acting as the main line of communication between the sponsor and
the investigator.
The Monitor should verify that the investigator(s) have the adequate
qualifications, expertise and the resources to carry out the study.
Monitor should ascertain that the institutional facilities like
laboratories, equipment, staff, storage space etc. are adequate for safe
and proper conduct of the study.
Responsibilities(Monitor):
31
Monitor should verify that the investigational product(s) are
sufficiently available throughout the study and is stored properly
Monitor should verify that the investigational product(s) are supplied
only to subjects who are eligible to receive it and at the specified
dose(s) and time(s)
Monitor should verify that the receipt, use, and return of the
investigational product(s) at the trial sites are controlled
and documented adequately.
Verifying that the investigator follows the approved protocol and all
approved amendment(s), if any.
Responsibilities(Monitor):
32
Monitor ensuring that the investigator receives the current
Investigator's Brochure.
The monitor(s) should follow the sponsor's established written SOPs
as well as those procedures that are specified by the sponsor for
monitoring a specific trial.
The monitor should submit a written report to the sponsor after each
trial-site visit or trial-related communication.
Determining whether all adverse events (AEs) are appropriately
reported within the time periods required by GCP.
Responsibilities(Monitor):
33
INVESTIGATOR:
A person responsible for the conduct of the study at the trial site.
Investigator is responsible for the rights, health and welfare of the
study subjects.
In case the study is conducted by a team of investigators at the study
site then the designated leader of the team should be the Principal
Investigator.
34
The investigator(s) should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the trial.
The investigator should be thoroughly familiar with the appropriate
use of the investigational product(s), as described in the protocol.
The investigator should be aware and should comply with, GCP and
applicable regulatory requirements.
The investigator should maintain a list of appropriately qualified
persons to whom the investigator has delegated significant trial-
related duties.
The investigator should have available an adequate number of
qualified staff.
Responsibilities(Investigator):
35
The investigator should be able to demonstrate (e.g., based on
retrospective data) a potential for recruiting the required number of
suitable subjects within the agreed recruitment period.
A qualified physician (or dentist, when appropriate), who is an
investigator or a sub investigator for the trial, should be responsible for
all trial-related medical (or dental) decisions.
Before initiating a trial, the investigator should have written and dated
approval from the IEC for the trial protocol, written informed consent
form, consent form updates, subject recruitment procedures (e.g.,
advertisements), and any other written information to be provided to
subjects.
Responsibilities(Investigator):
36
The investigator may assign some or all of his/her duties for
investigational product(s) to an appropriate pharmacist or other
appropriate individual who is under the supervision of the
investigator.
The investigator should follow the trial’s randomization procedures,
if any.
Prior to the beginning of the trial, the investigator should have the
IEC written approval of the written informed consent form and any
other written information to be provided to subjects.
The financial aspects of the trial should be documented in an
agreement between the sponsor and the investigator.
Responsibilities(Investigator):
37
The investigator should submit written summaries of the trial’s status
to the IEC annually, or more frequently, if requested by the IEC.
All SAEs should be reported immediately to the sponsor except for
those SAEs that the protocol or other document (e.g., Investigator's
Brochure) identifies as not needing immediate reporting.
Premature Termination or Suspension of trail:
Upon completion of the trial, the investigator should provide a
summary of the trail’s outcome, to the regulatory authority.
Responsibilities(Investigator):
38
STATISTICS
1. Role of 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.
39
2. Study Design
The scientific integrity of a Clinical Study and the credibility of its
report depends on the design of the Study. In comparative studies the
Protocol should describe:
Rationale for the Study.
methods of Randomization to avoid biasness.
STATISTICS
40
3. Statistical Analysis:
The type(s) of Statistical Analyses to be used must be clearly
identified and should form basis of the statistical model for the Study.
Any subsequent deviation(s) should be described and justified in the
Final Report.
Missing, unused and spurious data should be accounted for during
the statistical analyses.
STATISTICS
41
1. Clinical Trials of Vaccines:
Vaccine trials are typically tested through a study design called a
randomized, double-blind and placebo-controlled trial. This means
that participants are randomly assigned to receive either the
experimental vaccine or a placebo. A placebo is an inactive injection
that mimics the real experience to the patient.
Phases of Vaccine Trials:
The guidelines to conduct the clinical trial on investigational vaccines
are similar to those governing a clinical trial. The phase of these trials
differ from drug trials as given below:
 Phase I
SPEACIAL CONCERNS:
42
 Phase II
 Phase III
2. Clinical Trials of Contraceptives :
All procedures for clinical trials are applicable. Subjects should be
clearly informed about the alternative available.
In women where implant has been used as a contraceptive for trial, a
proper follow up for removal of the implant should be done, whether the
trial is over or the subject has withdrawn from the trial.
SPEACIAL CONCERNS:
43
3. Clinical trials for Diagnostic Agents - Use of Radio-
active Materials and X- Rays:
In human beings, for investigation and treatment, different radiations-
X-rays, gamma rays and beta rays, radio opaque contrast agents and
radioactive materials are used.
Radiation limits for the use of such materials and X-Rays should be
in accordance with the limits set forth by the regulatory authority
(BARC) for such materials.
SPEACIAL CONCERNS:
44
A clinical trial protocol is a document that outlines the study plan for
a clinical trial project.
PROTOCOL:
45
General Information:
 The protocol should include the sponsor, monitor, authorized signers,
sponsor's medical expert, investigator, qualified physician, and
clinical laboratory and other involved departments.
Objectives and Justification:
 Aims and objectives of the study,
 Name and description of the investigational product(s)
Ethical Considerations:
 General ethical considerations related to the study
Table of contents:
46
Study design:
 The scientific integrity of a Clinical Study and the credibility of its
report depends on the design of the Study.
Handling of the Product(s):
Specifications of the effect parameters to be used
Description of how effects are measured and recorded
Assessment of Safety
Specifications of safety parameters
Statistics
Table of contents:
47
Data handling and management:
Procedures for handling and processing records of effects and
adverse events to the product(s) under study
Finance and insurance:
Quality control and quality assurance:
Evaluation:
Table of contents:
48
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.
INVESTIGATOR‘S BROCHURE
49
1. Title Page
2. Confidentiality Statement
3. Contents of the Investigator's Brochure
A. Summary
B. Introduction
C. Physical, Chemical, and Pharmaceutical Properties and Formulation
D. Nonclinical Studies
General Consideration:
50
a) Nonclinical Pharmacology
b) Pharmacokinetics and Product Metabolism in Animals
c) Toxicology
E. Effects in Humans
F. Summary of Data and Guidance for the Investigator
General Consideration:
Schedule Y is a set of guidelines introduced under drug and cosmetic
act 1940, which provide standards and criteria to be followed in order
to obtain approval to
1) Importing
2) Making new drugs.
3) Conducting clinical trials.
It was first introduced in 1983 and has since been amended several
times to align with the latest scientific and regulatory requirements.
The objective of Schedule Y is to ensure that clinical trials are
conducted ethically, scientifically, and in the best interests of human
subjects
SCHEDULE Y:
52
1. Introduction:
A brief description of the drug and the therapeutic class to which it
belongs.
2. Chemical and pharmaceutical information:
Chemical name; code name or number, if any; non-proprietary or
generic name, if any; physio-chemical proportion.
3. Animal pharmacology:
a) Summary.
b) Specific pharmacological actions
4. Animal toxicology:
Table of content:
53
5. Human/clinical pharmacology (Phase I):
a) Summary.
b) Specific pharmacological actions.
6. Exploratory clinical trials (Phase II):
a) Summary
b) Investigator wise reports.
7. Confirmatory clinical trials (Phase III):
a) Summary
b) Investigator wise reports.
Table of content:
54
8. Special studies:
a) Summary
b) Bioavailability and dissolution studies.
9. Regulatory status in other countries:
a) Countries where: Marketed, Approved, Under trial
10.Marketing information:
a) Proposed product monograph
b) Drafts of labels and cartons
Table of content:
55
Sr. No. ICH GCP INDIAN GCP
1 ICH: International Council of
Harmonization
GCP: Good Clinical Practice.
CDSCO: Central Drug Standard Control
Organization.
2 Guidelines for all countries. Guidelines for India.
3 No Act is mentioned. Act : Drugs and Cosmetics Act 1940.
4 10 Principles of ICH GCP. 12 Ethical Principles are Mentioned.
ICH GCP vs INDIAN GCP:
56
ICH GCP vs INDIAN GCP:
5 Protocol: Different Point are-
a) Treatment of Subject
Protocol: Different Point are-
a) Handling of Product.
b) Evaluation.
6 IRB/IEC Responsibility:
An IRB/IEC should safeguard
the rights, safety, and well-
being of all trial subjects.
Special attention should be
paid to trials that may include
vulnerable subjects.
IEC Responsibility:
To protect the dignity, rights and well being of
the potential research participants.
57
7 Composition of IRB/IEC:
a) At least five members.
b) At least one member whose
primary area of interest is in
a non scientific area.
c) At least one member who is
independent of the
institution/trial site.
Composition of IEC:
a) Chairperson.
b) 1-2 basic medical scientists (preferably one
pharmacologists).
c) 1-2 clinicians from various Institutes .
d) One legal expert or retired judge.
e) One social scientist / representative of non-
governmental voluntary agency .
f) One philosopher / ethicist.
g) One lay person from the community .
h) Member Secretary
ICH GCP vs INDIAN GCP:
58
1. Cdsco.gov.in. 2023. Available from:
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.W
EB/elements/download_file_division.jsp?num_id=MzM5NQ==
Reference:
59
60

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INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRR

  • 1. INDIAN GCP GUIDELINE PRESENTED BY: Shrawan Kumar 2308212170011 M.PHARM 1Stsem (RA)
  • 2. TABLE OF CONTENT INTRODUCTION GCP PRINCIPLE INDEPENDENT ETHICS COMMITTEE INFORM CONSENT PROCESS RESPONSIBILITIES(SPONSOR, MONITOR, INVESTIGATOR) STATISTICS SPECIAL CONCERNS CLINICAL TRIAL PROTOCOL INVESTIGATOR’S BROCHURE SCHEDULE Y COMPARISON OF ICH GCP AND INDIAN GCP 2
  • 3. INTRODUCTION What is GCP? Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects Its aim is to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented. 3
  • 4. The guidelines seek to establish two cardinal principles: These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical research on Human Subjects issued by the Indian Council of Medical Research. Protection of the rights of human subjects Authenticity of biomedical data generated 4 INTRODUCTION
  • 5. All research involving human subjects should be conducted in accordance with the ethical principles contained in the current revision of Declaration of Helsinki. The following principles are to be followed: 1. Principles of essentiality. 2. Principles of voluntariness, informed consent and community agreement. 3. Principles of non-exploitation. 4. Principles of privacy and confidentiality. 5. Principles of precaution and risk minimization. GCP PRINCIPLES: 5
  • 6. 6.Principles of professional competence. 7.Principles of accountability and transparency. 8.Principles of the maximization of the public interest and of distributive justice. 9.Principles of institutional arrangements. 10.Principles of public domain. 11.Principles of totality of responsibility. 12.Principles of compliance. 6 GCP PRINCIPLES:
  • 7. INDEPENDENT ETHICS COMMITTEE: An Independent committee comprising of medical / scientific and non-medical / non-scientific members, whose responsibility is to verify the protection of dignity, rights, safety and well-being of human subjects involved in a study. 7
  • 8. Composition of IEC: IEC should be multidisciplinary and multi-sectorial in composition. The composition may be as follows :- 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 / theologian 7.One lay person from the community 8.Member Secretary 8
  • 9. Responsibility of IEC: IEC ensure a competent review of all ethical aspects of the project proposals received. To protect the dignity, rights and well being of the potential research participants. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs. To assist in the development and the education of a research community responsive to local health care requirements. 9
  • 10. The Ethics Committee should review every research proposal on human subjects. The Committee should evaluate the possible risks to the subjects with proper justification. The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals. Ensuring that the IEC promptly notify in writing the investigator/ institution concerning : a) Its trial related decisions/ opinions . b) The reasons for its decisions/ opinions . c) Procedures for appeal of its decisions/ opinions . 10 Responsibility of IEC:
  • 11. All documentation and communication of an IEC are to be dated, filed and preserved according to written procedures. Strict confidentiality is to be maintained during access and retrieval procedures. Records should be maintained for the following : 1.The curriculum vitae of all IEC members. 2.Standing operating procedures of the IEC. 3.National and international guidelines. It is recommended that all records must be safely maintained after the completion / termination of the study for at least a period of 5 years 11 Responsibility of IEC:
  • 12. Informed Consent Process: Informed consent is a process by which a subject voluntary confirms his/her willingness to participate in one or another clinical trial. And only after having been informed of all aspects of the study Informed consent should be documented by means of a written, signed and dated Informed Consent Form (ICF). 12
  • 13. Informed Consent of Subject : Prior to the beginning of the Study the Investigator(s) should obtain the Ethics Committee’s approval for the written informed consent form and all information being provided to the Subjects and / or their legal representatives or guardians. The information should be given to the Subjects and / or their legal representatives or guardians in a language and at a level of complexity that is understandable to the Subject(s) in both written and oral form The Investigator(s), Sponsor or staff of the Institution should not coerce or unduly influence a potential Subject to participate or to continue to participate in the Study 13
  • 14. Prior to the Subject’s participation in the Study the written Informed Consent form should be signed and personally dated by (i) The Subject (ii) Subject’s legal representative or guardian or (iii)An impartial witness (iv) The Investigator 14 Informed Consent of Subject :
  • 15. Content of Inform consent Essential information that must be provided to the subject should contain 1) Aims and methods of research 2) Expected duration 3) Reasonable expected benefits 4) Alternative Procedure if any 5) Foreseeable risks 6) Free treatment to research related injury 15
  • 16. 7) Compensation 8) Voluntary participation 9) Phone no and address of the contact persons 10)All information about the biological material and data generated from the person 11)Risk of discovery of biological sensitive information 16 Content of Inform consent
  • 17. Compensation for Participation: All payments, reimbursement and medical services to be provided to research subjects should be approved by the IEC. Care should be taken: 1) when a subject is withdrawn from research for medical reasons related to the study the subject should get the benefit for full participation; 2) Then a subject withdraws for any other reasons he/she should be paid in proportion to the amount of participation. 17
  • 18. Compensation for Accidental Injury Research subjects who suffer physical injury as a result of their participation in the Clinical Trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from IEC In case of death, their dependents are entitled to material compensation 18
  • 19. Selection of Special Groups As Research Subject 1) Pregnant or nursing women: Pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation 19
  • 20. 2) Children: • The purpose of the research is to obtain knowledge relevant to health needs of children. For clinical evaluation of a new drug the study in children should always be carried out after the phase III clinical trials in adults. • A parent or legal guardian of each child has given proxy consent. • The assent of the child should be obtained • The child's refusal to participate in research must always be respected unless there is no medically acceptable alternative to the therapy provided/tested, provided the consent has been obtained from parents/guardian; Selection of Special Groups As Research Subject 20
  • 21. 3) Vulnerable group: • Effort may be made to ensure that individuals or communities invited for research be selected in such a way that the burdens and benefits of the research are equally distributed. • Rights and welfare of mentally challenged and mentally differently able persons who are incapable of giving informed consent or those with behavioral disorders must be protected. • Adequate justification is required for the involvement of subjects such as prisoners, students, subordinates, employees, service personnel etc. who have reduced autonomy as research subjects. Selection of Special Groups As Research Subject 21
  • 22. SPONSOR: An individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial. 22
  • 23. Quality Assurance and Quality Control: The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs Contract Research Organization (CRO): A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO. Trial Design: The sponsor should utilize qualified individuals (e.g., biostatisticians, clinical pharmacologists, and physicians) as appropriate. Medical Expertise :The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems. Responsibilities(Sponsor): 23
  • 24. Trial Management, Data Handling, and Recordkeeping:  The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.  The sponsor should use an unambiguous subject identification code that allows identification of all the data reported for each subject.  The sponsor is responsible for selecting the investigator(s).  The sponsor should obtain the investigator's/institution's agreement:  To conduct the trial in compliance with GCP, Responsibilities(Sponsor): 24
  • 25. Responsibilities(Sponsor):  To comply with procedures for data recording/reporting,  To permit monitoring, auditing, and inspection Compensation to Subjects and Investigators:  The sponsor should provide insurance.  The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s) Financing:  The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator. 25
  • 26. Confirmation of review by the Ethics Committee:  An undertaking that the Ethics Committee is organized and operates according to the GCP and the applicable laws and regulations Information on Investigational Product(s):  When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied. Adverse Drug Reaction Reporting:  The Sponsor should provide ADR / AE reporting forms to the Investigator(s) / Institution(s). Responsibilities(Sponsor): 26
  • 27. Audit:  Sponsor should perform an audit as a part of QA system. This audit should be conducted with the purpose of being independent and separate from routine monitoring or quality control functions. Notification/Submission to Regulatory Authority:  Before initiating the clinical trial, the sponsor should submit any required application(s) to the appropriate authority for review, acceptance, and permission (as required by the applicable regulatory requirement(s)) to begin the trial(s).  Any notification/submission should be dated and contain sufficient information to identify the protocol. Responsibilities(Sponsor): 27
  • 28. Manufacturing, Packaging, Labeling, and Coding Investigational Product(s):  The sponsor should ensure that the investigational product(s) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP.  The labeling should comply with applicable regulatory requirement(s).  The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage time. Responsibilities(Sponsor): 28
  • 29. A person appointed by the Sponsor or Contract Research Organization (CRO) for monitoring and reporting the progress of the trial and for verification of data. The monitor ensures that the trial is conducted, recorded and reported in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements. MONITOR: 29
  • 30. Selection and Qualifications of Monitors: Monitor should be appointed by the Sponsor or Contract Research Organization (CRO). The monitor should have adequate medical, pharmaceutical and / or scientific qualifications and clinical trial experience. A monitor's qualifications should be documented. Monitor should be fully aware of all the aspects of the product under investigation, protocol, written informed consent form and any other written information to be provided to subjects. 30
  • 31. The main responsibility of the monitor is to oversee the progress of the study. Acting as the main line of communication between the sponsor and the investigator. The Monitor should verify that the investigator(s) have the adequate qualifications, expertise and the resources to carry out the study. Monitor should ascertain that the institutional facilities like laboratories, equipment, staff, storage space etc. are adequate for safe and proper conduct of the study. Responsibilities(Monitor): 31
  • 32. Monitor should verify that the investigational product(s) are sufficiently available throughout the study and is stored properly Monitor should verify that the investigational product(s) are supplied only to subjects who are eligible to receive it and at the specified dose(s) and time(s) Monitor should verify that the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately. Verifying that the investigator follows the approved protocol and all approved amendment(s), if any. Responsibilities(Monitor): 32
  • 33. Monitor ensuring that the investigator receives the current Investigator's Brochure. The monitor(s) should follow the sponsor's established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial. The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication. Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP. Responsibilities(Monitor): 33
  • 34. INVESTIGATOR: A person responsible for the conduct of the study at the trial site. Investigator is responsible for the rights, health and welfare of the study subjects. In case the study is conducted by a team of investigators at the study site then the designated leader of the team should be the Principal Investigator. 34
  • 35. The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol. The investigator should be aware and should comply with, GCP and applicable regulatory requirements. The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial- related duties. The investigator should have available an adequate number of qualified staff. Responsibilities(Investigator): 35
  • 36. The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. A qualified physician (or dentist, when appropriate), who is an investigator or a sub investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. Before initiating a trial, the investigator should have written and dated approval from the IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects. Responsibilities(Investigator): 36
  • 37. The investigator may assign some or all of his/her duties for investigational product(s) to an appropriate pharmacist or other appropriate individual who is under the supervision of the investigator. The investigator should follow the trial’s randomization procedures, if any. Prior to the beginning of the trial, the investigator should have the IEC written approval of the written informed consent form and any other written information to be provided to subjects. The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator. Responsibilities(Investigator): 37
  • 38. The investigator should submit written summaries of the trial’s status to the IEC annually, or more frequently, if requested by the IEC. All SAEs should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. Premature Termination or Suspension of trail: Upon completion of the trial, the investigator should provide a summary of the trail’s outcome, to the regulatory authority. Responsibilities(Investigator): 38
  • 39. STATISTICS 1. Role of 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. 39
  • 40. 2. Study Design The scientific integrity of a Clinical Study and the credibility of its report depends on the design of the Study. In comparative studies the Protocol should describe: Rationale for the Study. methods of Randomization to avoid biasness. STATISTICS 40
  • 41. 3. Statistical Analysis: The type(s) of Statistical Analyses to be used must be clearly identified and should form basis of the statistical model for the Study. Any subsequent deviation(s) should be described and justified in the Final Report. Missing, unused and spurious data should be accounted for during the statistical analyses. STATISTICS 41
  • 42. 1. Clinical Trials of Vaccines: Vaccine trials are typically tested through a study design called a randomized, double-blind and placebo-controlled trial. This means that participants are randomly assigned to receive either the experimental vaccine or a placebo. A placebo is an inactive injection that mimics the real experience to the patient. Phases of Vaccine Trials: The guidelines to conduct the clinical trial on investigational vaccines are similar to those governing a clinical trial. The phase of these trials differ from drug trials as given below:  Phase I SPEACIAL CONCERNS: 42
  • 43.  Phase II  Phase III 2. Clinical Trials of Contraceptives : All procedures for clinical trials are applicable. Subjects should be clearly informed about the alternative available. In women where implant has been used as a contraceptive for trial, a proper follow up for removal of the implant should be done, whether the trial is over or the subject has withdrawn from the trial. SPEACIAL CONCERNS: 43
  • 44. 3. Clinical trials for Diagnostic Agents - Use of Radio- active Materials and X- Rays: In human beings, for investigation and treatment, different radiations- X-rays, gamma rays and beta rays, radio opaque contrast agents and radioactive materials are used. Radiation limits for the use of such materials and X-Rays should be in accordance with the limits set forth by the regulatory authority (BARC) for such materials. SPEACIAL CONCERNS: 44
  • 45. A clinical trial protocol is a document that outlines the study plan for a clinical trial project. PROTOCOL: 45
  • 46. General Information:  The protocol should include the sponsor, monitor, authorized signers, sponsor's medical expert, investigator, qualified physician, and clinical laboratory and other involved departments. Objectives and Justification:  Aims and objectives of the study,  Name and description of the investigational product(s) Ethical Considerations:  General ethical considerations related to the study Table of contents: 46
  • 47. Study design:  The scientific integrity of a Clinical Study and the credibility of its report depends on the design of the Study. Handling of the Product(s): Specifications of the effect parameters to be used Description of how effects are measured and recorded Assessment of Safety Specifications of safety parameters Statistics Table of contents: 47
  • 48. Data handling and management: Procedures for handling and processing records of effects and adverse events to the product(s) under study Finance and insurance: Quality control and quality assurance: Evaluation: Table of contents: 48
  • 49. 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. INVESTIGATOR‘S BROCHURE 49
  • 50. 1. Title Page 2. Confidentiality Statement 3. Contents of the Investigator's Brochure A. Summary B. Introduction C. Physical, Chemical, and Pharmaceutical Properties and Formulation D. Nonclinical Studies General Consideration: 50
  • 51. a) Nonclinical Pharmacology b) Pharmacokinetics and Product Metabolism in Animals c) Toxicology E. Effects in Humans F. Summary of Data and Guidance for the Investigator General Consideration:
  • 52. Schedule Y is a set of guidelines introduced under drug and cosmetic act 1940, which provide standards and criteria to be followed in order to obtain approval to 1) Importing 2) Making new drugs. 3) Conducting clinical trials. It was first introduced in 1983 and has since been amended several times to align with the latest scientific and regulatory requirements. The objective of Schedule Y is to ensure that clinical trials are conducted ethically, scientifically, and in the best interests of human subjects SCHEDULE Y: 52
  • 53. 1. Introduction: A brief description of the drug and the therapeutic class to which it belongs. 2. Chemical and pharmaceutical information: Chemical name; code name or number, if any; non-proprietary or generic name, if any; physio-chemical proportion. 3. Animal pharmacology: a) Summary. b) Specific pharmacological actions 4. Animal toxicology: Table of content: 53
  • 54. 5. Human/clinical pharmacology (Phase I): a) Summary. b) Specific pharmacological actions. 6. Exploratory clinical trials (Phase II): a) Summary b) Investigator wise reports. 7. Confirmatory clinical trials (Phase III): a) Summary b) Investigator wise reports. Table of content: 54
  • 55. 8. Special studies: a) Summary b) Bioavailability and dissolution studies. 9. Regulatory status in other countries: a) Countries where: Marketed, Approved, Under trial 10.Marketing information: a) Proposed product monograph b) Drafts of labels and cartons Table of content: 55
  • 56. Sr. No. ICH GCP INDIAN GCP 1 ICH: International Council of Harmonization GCP: Good Clinical Practice. CDSCO: Central Drug Standard Control Organization. 2 Guidelines for all countries. Guidelines for India. 3 No Act is mentioned. Act : Drugs and Cosmetics Act 1940. 4 10 Principles of ICH GCP. 12 Ethical Principles are Mentioned. ICH GCP vs INDIAN GCP: 56
  • 57. ICH GCP vs INDIAN GCP: 5 Protocol: Different Point are- a) Treatment of Subject Protocol: Different Point are- a) Handling of Product. b) Evaluation. 6 IRB/IEC Responsibility: An IRB/IEC should safeguard the rights, safety, and well- being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects. IEC Responsibility: To protect the dignity, rights and well being of the potential research participants. 57
  • 58. 7 Composition of IRB/IEC: a) At least five members. b) At least one member whose primary area of interest is in a non scientific area. c) At least one member who is independent of the institution/trial site. Composition of IEC: a) Chairperson. b) 1-2 basic medical scientists (preferably one pharmacologists). c) 1-2 clinicians from various Institutes . d) One legal expert or retired judge. e) One social scientist / representative of non- governmental voluntary agency . f) One philosopher / ethicist. g) One lay person from the community . h) Member Secretary ICH GCP vs INDIAN GCP: 58
  • 59. 1. Cdsco.gov.in. 2023. Available from: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.W EB/elements/download_file_division.jsp?num_id=MzM5NQ== Reference: 59
  • 60. 60