The document outlines the roles and responsibilities of key participants in clinical trials, including investigators, study coordinators, and sponsors, while describing different phases of clinical trials and types of clinical studies. It emphasizes the importance of following good clinical practice (GCP) standards, obtaining informed consent, and ensuring participant safety. Additionally, the document details the functions of contract research organizations in facilitating clinical studies and managing data.

1. Roles and Responsibilities in
Clinical Trials of
Investigator,
Study Coordinator,
Sponsor.
Presented By:- Tejas D. Kanhed
Guide By:- P. G. Jain
Dept. of Pharmacology,
RCPIPER,Shirpur. 425405

2. ROLES AND RESPONSIBILITIE
01
INVESTIGATOR
03
SPONSOR
02
COORDINATOR
04
MONITOR
05
CONTRACT
RESEARCH
ORGANIZATION.

3.  RESPONSIBILITIES
The opportunity or ability to act independently and take decisions without
authorization.
 ROLE
A prescribed or expected behavior associated with a particular position or status in a
group, Organization.
GLOSSARY

4.  CLINIC
A facility devoted to diagnosis and treatment or rehabilitation of outpatients.
 CLINICAL STUDY
Study specialized or therapeutic care that requires on going assessment, planning,
intervention and evaluation by health care professionals.
 TRIAL
A large number of participants, a small difference between treatment and control groups may
be statistically significant.

5. CLINICAL TRIAL video
A controlled research study of the safety and
effectiveness of drugs, devices or techniques
that occurs in four phases, starting with the
enrolment of a small number of people, to the
later stages in which thousands of people are
involved prior to approval by the licensing
authority.

6. DIFFERENT TYPES OF CLINICAL TRIALS
 Treatment trials:- Test experimental treatments, new combinations of drugs, or new approaches to
surgery or radiation therapy.
 Prevention trials:- Look for better ways to prevent disease in people who have never had the disease or
to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins,
minerals, or lifestyle changes.
 Diagnostic trials:- are conducted to find better tests or procedures for diagnosing a particular disease
or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or
condition being studied.
 Screening (Early detection) trials:-test the best way to detect certain diseases or health conditions.

7. DIFFERENT PHASES OF CLINICAL TRIALS
 PRE-CLINICAL:-It involves in vitro (test tube) and in vivo (animal) experiments using wide ranging
doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information.
 PHASE I TRIALS :-Initial studies to determine the metabolism and pharmacologic actions of drugs
in humans, the side effects associated with increasing doses.
 PHASE II TRIALS :- Controlled clinical studies conducted to evaluate the effectiveness of the drug
for a particular indication or indications in patients with the disease or condition.
 PHASE III TRIALS:- Expanded controlled and uncontrolled trials after preliminary evidence
suggesting effectiveness of the drug has been obtained.
 PHASE IV TRIALS:- Post-marketing studies.

8. A clinical trial is a research study that tests a new medical
treatment or a new way of using an existing treatment to
see if it will be a better way to prevent and screen for
diagnose or treat a disease.
CLINICAL TRIAL STUDY TEAM

9. REQUIREMENT OF CLINICAL TRIAL STUDY TEAM
Sufficient study
staff to perform
clinical research.
01 02 Appropriate
skill set and
training.
04 Follow protocol
requirements.
03
Follow GCP
(Good Clinical
Practice)
standard.

10. RESEARCH TEAM ROLE
Ensure that ....
 The correct version of the protocol is
followed. Potential participants are provided
with information.
 The Content of informed Consent form is
properly stated.
Reporting of…
 Any failures in these
respects or suspected
misconduct.
Report…
 Adverse incidents, events
or drug reactions.

11. RESEARCH TEAM RESPONSIBILITY
Appropriate skill set and training.
GCP (Good Clinical Practice) standards.
Follow protocol requirements.

12. INVESTIGATOR
An individual who conducts a clinical investigation or in the
event of an investigation conducted by a team of individuals,
is the responsible leader of the team.
CO-INVESTIGATOR
A member of the research team designated and supervised by
the protocol investigation to perform critical study-related
procedures and to make important study-related decisions
sub-investigators as those individuals authorized to make
medical judgments and decisions regarding study subject.

13. 1. Interactions for applicable federal, state, and local regulatory authority.
2. Follow ethical principles and standards.
3. Discipline in designing and conducting clinical trials for policies,
procedures.
4. Education programs are provided.
6. Refer to Section Good Clinical Practice (GCP) Course for
training requirements.
7. The ultimate responsibility for the scientific, technical, and
administrative aspects of the research project.
INVESTIGATORS' ROLE

14. 1. Conducting the trial ,statement, protocol, and applicable regulations.
2. Protecting the rights, safety, and welfare of trial participants.
3. Obtaining informed consent from all trial participants.
4. Maintaining proper records.
5. Managing all progress reports, safety reports, financial disclosure reports.
6. Discussed in the Roles and Responsibilities module Based on GCP guidelines.
7. Ensuring that the Investigational Product.
8. Used in accordance with the approved protocol.
9. Qualification.
INVESTIGATORS' RESPONSIBILITIES

15. STUDY-COORDINATOR
❏ Coordinator Research Committee (CRC)
also has a critical role in facilitating,
supporting and coordinating daily clinical
research study activities. The CRC works
under the direction of the PI who will
delegate specific clinical research study
related tasks.

16. ROLE :
1. Conduct of a research study.
2.The CRC carries forward the research goals.
3.CRCs are often involved inessential duties that ensure compliance with the protocol and
protection of human subjects.
4.Preparing the institutional review board (IRB) submission.
5.Writing the informed consent document,recruiting and consenting participants.
6. Coordinating and conducting study visits, adverse event reporting, completing case report
forms (crf’s)
7. Managing data and collecting biological specimens.

17. STUDY-COORDINATOR RESPONSIBILITIES
01
Complete the required of Course before initiation
of any clinical research related activity.
Human Research Protection Program(HRPP)
Collaborative Institutional Training Initiative
(CITI)
02
Provide regulatory, institutional, sponsor
and protocol requirements for the study.
03
Complete with all IRB decisions,
conditions and requirements.
04
Ensure all studies have
current IRB approval.
05
Coordinate with the PI and
other key research personnel.
06
Ensure that Protected Health
Information (PHI) will not be
disclosed to any parties.

18. SPONSOR
01 Financial
02 Reputation
03 Legal
Sponsor is an “individual ,organization or partnership that takes on overall responsibility for
effective arrangements being in place to set up, run and report on a research project”.
ROLE OF SPONSOR

19. SPONSOR’S RESPONSIBILITIES :
03
• Ensuring
conducted in
accordance with
the plan
and protocols.
04
• Maintaining an
effective respect
to the
investigation.
02
• Ensuring
proper
monitoring of
the
investigation.
01
• Selecting and
providing qualified
investigators.

20. CLINICAL MONITOR
The person with direct access to patient’s medical records to
verify data and procedure acting with in the constraints of the
applicable regulatory requirement to maintain the confidentiality
of subjects’ identities and sponsor’s proprietary information.
The clinical monitor is the passage between the investigator and
sponsor.

21. ROLE :-
1. Director monitoring.
2. Medical monitoring .
3. Management monitoring.
4. Scientific monitoring.

22. RESPONSIBILITY
 Assign to appropriate protocols.
 Review from activities as applicable.
 Review protocol rules.
 Advise protocol team on safety oversight.
 Evaluate and reviews safety reports.
 Assist with pharmacovigilance activities.

23. CONTRACT
RESEARCH
ORGANIZATION

24. CONTRACT RESEARCH ORGANIZATION
A Contract Research Organization (CRO) is a service organization which
provides various pharmaceutical research that is essential for conducting
clinical trials in the present various complications are involved in the drug
process.
ROLE :-
1. Project management.
2. Database design & build.
3. Data entry & validation.
4. Clinical trial data management.
5. Medicine and disease coding.

25. CONTT…
6. Quality and metric reporting.
7. Statistical analysis plans and reports.
8. Validation programming.
9. Safety and efficacy summaries.
10. Final study report.

26. CONTRACT RESEARCH ORGANIZATION RESPONSIBILITIES :-
03
Conduct
study actives.
04
Manage
processes.
02
Provide
adequate,
well manage
staff.
01
Evaluate
feasibility.
05
Ensure that
the solution
are cost-
effective.

27. References
1) World Health Organization, 2004. A glossary of terms for community health care and services for older persons. WHO.2. (C)
(1. Information about clinical trial. Available from : URLhttp://www.temple.edu/pascope/about_trials.html ).
2) Thorat, S.B., Banarjee, S.K., Gaikwad, D.D., Jadhav, S.L. and Thorat, R.M., 2010. Clinical trial: a review. Int J Pharm Sci Rev
Res, 1, pp.101-6.
3) Roberts, B.L., Rickard, C.M., Foote, J. and McGrail, M.R., 2006. The best and worst aspects of the ICU research coordinator
role. Nursing in Critical Care, 11(3), pp.128-135.
4)https://www.fda.gov/downloads/training/cdrhlearn/ucm176457.pdf.
5)Read more:http://www.businessdictionary.com /definition /role.htm.l
6) R. Sridhar*, Ch. V. Hemanth and N. Durga Deepak CLINICAL TRIALS AND ROLE OF PHARMACIST
7) https://swayam.gov.in/nd1_noc20_ge13/preview

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