This document provides an overview of clinical trial teams and their responsibilities. It defines a clinical trial and outlines the approval process. The main stakeholders in a clinical trial are identified as the sponsor, investigators, ethics committee, regulatory authorities, and study subjects. Key responsibilities are described for each stakeholder. The clinical trial process is outlined as initiating a trial, conducting it, closing it, and registering/publishing results. Specific responsibilities are defined for investigators, study coordinators, sponsors, and contract research organizations.

1. CLINICAL TRIAL
TEAM
IRENE.V.R
Ist M.PHARM
PHARMACY PRACTICE
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2. CONTENTS:
 INTRODUCTION
 CLINICAL TRAIL DEFINITION
 APPROVAL FOR CLINICAL TRAIL
 CLINICAL TRAIL STUDY TEAM
 CHIEF RESPONSIBILITIES OF STAKE HOLDERS
 CLINICAL TRAIL PROCESS
 REPONSIBILITIES OF : INVESTIGATOR
 SPONSOR
 STUDY COORDINATOR
 CRO
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3. CLINICAL TRIAL
 Clinical trail is defined as the systematic study in
human subjects intended to discover or verify the
clinical, pharmacological and other
pharmacodynamic effects of an investigatonal
product
 Study absorption, distribution, metabolism and
excretion of an investigational product.
 Main objective is to determine safety and efficacy of
the new drug
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4. APPROVAL FOR CLINICAL TRIAL
 Clinical trail on a new drug can be initiated only after
the permission of licensing authority and approval of
ethics committee
 All trail investigators should possess appropriate
qualification, training and experience
 Laboratories used for generating data should be
complaint with good laboratory practice(GLP)
 All protocol amendments should notified to the
licensing authority in writing along with approval of
ethics committee 4

5. CLINICAL TRIAL STUDY TEAM
(CLINICAL TRAIL STAKE HOLDERS)
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SPONSOR/
CRO
investigator
STUDY
SUBJECT
IRB/ IEC
REGULATORY
AUTHORITY

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8. CHIEF RESPONSIBILITIES OF STAKE HOLDERS :
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slno
stake holder
Sponsor/
CRO
Investigator
Responsibilities
 Trial planning and
allocation of resources
Data monitoring &
management
Ensuring complaince with
GCP guidelines
Publication of trail result
Study conduct/ enrolment
of study subjects
Medical care of subjects
Ensure GCP guidelines
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2.

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3. IRB / IEC  trail permission / approval
Review of tail process
Trail termination / suspension
Ensure GCP guidelines
4. Regulatory
authority
• trail permission /approval
Review of trail process
Trail termination / suspension
Ensure GCP guidelines
inspection
5. Study subject •Voluntary participation & protocol
compliance

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11. CLINICAL TRAIL PROCESS
 Initiating a clinical trail
 Conduct a trail
 Trail closure
 Registration/ publication
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12. 1. INVESTIGATOR
 A person responsible for the conduct of clinical trail.
 If a trail is conducted by the team of individuals at trail site,
the investigator is responsible leader of the team (
principal investigator )
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 An Investigator is responsible for ensuring that an
investigation is conducted according to the signed
investigator statement
 The investigational plan, and applicable regulations; for
protecting the rights, safety and welfare of the subjects
under the investigator’s care; and for the control of the
drugs under investigation

14. RESPONSIBILITIES OF THE INVESTIGATOR
 Responsible for conducting the trails based on protocol
and GCP guidelines
 SOPs for tasks performed are to be documented
 Ensure adequate medical care for patients for any
adverse event
 Serious/ unexpected ADR should be reported to the
sponsor within 24 hours & to ethics commitee within 7
days of occurence
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15. IRB review and
approval
Record keeping
Informed
consent
ADR reporting
Protocol
complaince
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PRINCIPAL
INVESTIGATOR

16.  A written and freely given consent is necessary from each
research participant
 Investigator must provide written as well as verbal
information in a understandable language before taking
informed consent
 In case of unconscious person / minor or any persons
suffering from illness/ disability , legally acceptable
representative may give the consent
 If representative is unable to read/write the whole process ,
should be conducted in presence of an impartial witness
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20. 2. STUDY COORDINATOR
 manages and conducts the day-to-day study activities in
accordance with the protocol, applicable regulations and
GCP requirements
RESPONSIBILITIES :
 The responsibilities of the study coordinator have
expanded to beyond the clinical management of subjects
 much more sophisticated expertise in compliance,
research administration, marketing, fiscal and legal
activities
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 Study Coordinator is responsible for conducting trials as per
the GCP guidelines under the supervision of the Principal
Investigator (PI).
 Although the PI has the overall responsibility for performing
the trial, it has been stated that the CRC is the heart and
soul of the clinical trial
 ensure the protection and well-being of the patients
participating in the study

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DUTIES OF STUDY COORDINATOR:
 Take part in preparation and control of research budgets
and financial payments.
 Notify subjects regarding all study aspects relevant to
them.
 Enter study data into the applicable database.
 Keep track of study activities to make sure compliance
with protocols and with all related local, state, and national
regulatory and institutional polices.
 Manage necessary records of study related activity which
includes case report forms, drug dispensation records etc.

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 Communicate with laboratories or researchers about
laboratory findings
 Obtain industry-sponsored studies via personal contacts
and professional organizations
 Direct the request, collection, labelling, storage, or
shipment of samples
 Take part in meetings and seminars to update knowledge
of clinical research and related issues
 Enroll subjects in the study as per the study protocol.

24. 3. SPONSOR :
• An individual, company, institution, organisation, which
takes responsibility for the initiation, management &
financing of clinical trail
RESPONSIBILITIES :
 Sponsor is responsible for implementing and maintaining
quality assurance system through complaince with GCP,
SOPs should be documented to ensure complaince with
GCP
 Sponsor is required to submit a status report to the
licensing authority at the prescribed periodicity
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25.  If study is discontinued prematurely, report consisting of
breif description of study, no.of patients exposed , dose,
duration of exposure details of ADR, reasons for
discontinuation, should be submittted within 3 months
o Unexpected serious adverse event should be
communicated to the licensing authority within 14 days
and to the other investigator
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26. 4. ETHICS COMMITTEE :
 An independent body constituted of medical
proffesionals & non- medical members, whose
responsibility is to ensure protection of rights, safety of
human subjects involved in clinical trails
REPONSIBILITIES :
 Take care of safe guard the rights, safety and well being of
all research participants
 Should have the SOPs and maintain a record
 Review the trails periodically based on progress report
 Revoking the approval decision must be communicated to
the investigator & licensing authority 26

27. 5. CRO (CONTRACT RESEARCH
ORGANIZATION
 Company that provide clinical trail management services
 RESPONSIBILITIES :
 Protocol development
 Site/ investigator selection
 Personnel training
 Clinical trail management
 Data analysis
 Quality assurance
 Liaison with regulatory bodies
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29. REFERENCE
1. 1.Guruprasad mohantaTextbook of clinical research.2nd
edition2017.pharmaMed press;(26-35).
2. Philip Mirowski and Robert Van Hor.The Contract
Research Organization and the Commercialization of
Scientific Research ;2013
3. Stuart McLennan, PhD; Alexandra Griessbach, MSc;
Matthias Briel, MD, PhD, Practices and Attitudes of
Swiss Stakeholders Regarding Investigator-Initiated
Clinical Trial Funding Acquisition and Cost
Management,2021
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