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CLINICAL TRIAL STUDY TEAM
( Roles and Responsibilities)
PRESENTED BY
Bharat M. Patil
M . Pharmacy 1stYear(Department of Pharmacology)
R. C. Patel Institute of Pharmaceutical Education and Research,
Shirpur
ROLES AND RESPONSIBILITIE
 INVESTIGATOR
COORDINATOR
 SPONSOR
 MONITOR
 CONTRACT RESEARCH ORGANIZATION.
2
GLOSSARY
RESPONSIBILITIES
The opportunity or ability to act independently and take
decisions without authorization.
ROLE
A prescribed or expected behaviour
associated with a particular position
or status in a group, Organization.
CLINIC
A facility devoted to diagnosis and treatment or rehabilitation of
outpatients.
3
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
4
CLINICAL TRIAL
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.
5
CLINICAL TRIAL STUDY TEAM
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.
6
REQUIREMENT OF CLINICAL TRIAL STUDY TEAM
1. Sufficient study staff to perform clinical
research.
2. Appropriate skill set and training.
3. Follow GCP (Good Clinical Practice)
standard.
4. Follow protocol requirements.
7
RESEARCH TEAM ROLE
1. 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.
8
• Protection of integrity and confidentiality of records and
data is taking Place.
2. Reporting of any failures in these respects or suspected
misconduct.
3. Report adverse incidents, events or drug reactions.
9
CONT…
RESEARCH TEAM RESPONSIBILITY
• Appropriate skill set and training.
• GCP (Good Clinical Practice) standards.
•Follow protocol requirements.
10
INVESTIGATOR
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
11
INVESTIGATORS' RESPONSIBILITIES
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.
12
4. Maintaining proper records.
5. Managing all progress reports, safety reports, financial
disclosure reports.
13
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.
CONT…..
INVESTIGATORS' ROLE
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.
14
4. Education programs are provided.
CONT….
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.
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.
17
CONT…..
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.
18
RESPONSIBILITIES
1. Complete the required of Course before initiation of
any clinical research related activity.
Human Research Protection Program(HRPP)
Collaborative Institutional Training Initiative (CITI)
2. Provide regulatory, institutional, sponsor and protocol
requirements for the study.
3. Complete with all IRB decisions, conditions and
requirements.
19
CONT…..
4. Ensure all studies have current IRB approval.
5. Coordinate with the PI and other key research personnel.
6. Ensure that Protected Health Information (PHI) will not be
disclosed to any parties.
20
SPONSOR
sponsor is an “individual ,organisation or partnership that
takes on overall responsibility for effective arrangements
being in place to set up, run and report on a research
project”.
21
ROLE OF SPONSOR
1. Financial –
2. Reputation
3. Legal
SPONSOR’S RESPONSIBLE :
• Selecting and providing qualified investigators.
• Ensuring proper monitoring of the investigation.
• Ensuring conducted in accordance with the plan
and protocols.
• Maintaining an effective respect to the investigation.
22
MONITOR
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.
23
ROLE
1. Director monitoring.
2. Medical monitoring .
3. Management monitoring.
4. Scientific monitoring.
24
RESPONSIBILITY
• Assign to appropriate protocols.
• Review from activities as applicable.
• Review protocol rules.
•Advise protocol team on safety oversight.
25
• Evaluate and reviews safety reports.
• Assist with pharmacovigilance activities.
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.
26
ROLE
1. Project management.
2. Database design & build.
3. Data entry & validation.
4. Clinical trial data management.
5. Medicine and disease coding.
27
CONT…..
6. Quality and metric reporting.
7. Statistical analysis plans and reports.
8. Validation programming.
9. Safety and efficacy summaries.
10. Final study report.
28
1. Evaluate feasibility.
2. Provide adequate, well manage staff.
3. Conduct study actives.
4. Manage processes.
5. Ensure that the solution are cost-effective.
RESPONSIBILITY
29
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) Carlos, R.A., 2017. Improving Faculty Participation in Student Conduct Hearing
Boards: A Gap Analysis (Doctoral dissertation, University of Southern California).
4) 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.
5)https://www.fda.gov/downloads/training/cdrhlearn/ucm176457.pdf.
6)Read more:http://www.businessdictionary.com /definition /role.htm.l
7) National Drug Policy and Authority Act 2000 Edition
8) R. Sridhar*, Ch. V. Hemanth and N. Durga Deepak CLINICAL TRIALS AND ROLE OF
PHARMACIST
REFERENCE
30
31

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Clinical trial study team

  • 1. CLINICAL TRIAL STUDY TEAM ( Roles and Responsibilities) PRESENTED BY Bharat M. Patil M . Pharmacy 1stYear(Department of Pharmacology) R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur
  • 2. ROLES AND RESPONSIBILITIE  INVESTIGATOR COORDINATOR  SPONSOR  MONITOR  CONTRACT RESEARCH ORGANIZATION. 2
  • 3. GLOSSARY RESPONSIBILITIES The opportunity or ability to act independently and take decisions without authorization. ROLE A prescribed or expected behaviour associated with a particular position or status in a group, Organization. CLINIC A facility devoted to diagnosis and treatment or rehabilitation of outpatients. 3
  • 4. 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 4
  • 5. CLINICAL TRIAL 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. 5
  • 6. CLINICAL TRIAL STUDY TEAM 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. 6
  • 7. REQUIREMENT OF CLINICAL TRIAL STUDY TEAM 1. Sufficient study staff to perform clinical research. 2. Appropriate skill set and training. 3. Follow GCP (Good Clinical Practice) standard. 4. Follow protocol requirements. 7
  • 8. RESEARCH TEAM ROLE 1. 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. 8
  • 9. • Protection of integrity and confidentiality of records and data is taking Place. 2. Reporting of any failures in these respects or suspected misconduct. 3. Report adverse incidents, events or drug reactions. 9 CONT…
  • 10. RESEARCH TEAM RESPONSIBILITY • Appropriate skill set and training. • GCP (Good Clinical Practice) standards. •Follow protocol requirements. 10
  • 11. INVESTIGATOR 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 11
  • 12. INVESTIGATORS' RESPONSIBILITIES 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. 12
  • 13. 4. Maintaining proper records. 5. Managing all progress reports, safety reports, financial disclosure reports. 13 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. CONT…..
  • 14. INVESTIGATORS' ROLE 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. 14 4. Education programs are provided.
  • 15. CONT…. 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. 15
  • 16. 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
  • 17. 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. 17
  • 18. CONT….. 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. 18
  • 19. RESPONSIBILITIES 1. Complete the required of Course before initiation of any clinical research related activity. Human Research Protection Program(HRPP) Collaborative Institutional Training Initiative (CITI) 2. Provide regulatory, institutional, sponsor and protocol requirements for the study. 3. Complete with all IRB decisions, conditions and requirements. 19
  • 20. CONT….. 4. Ensure all studies have current IRB approval. 5. Coordinate with the PI and other key research personnel. 6. Ensure that Protected Health Information (PHI) will not be disclosed to any parties. 20
  • 21. SPONSOR sponsor is an “individual ,organisation or partnership that takes on overall responsibility for effective arrangements being in place to set up, run and report on a research project”. 21 ROLE OF SPONSOR 1. Financial – 2. Reputation 3. Legal
  • 22. SPONSOR’S RESPONSIBLE : • Selecting and providing qualified investigators. • Ensuring proper monitoring of the investigation. • Ensuring conducted in accordance with the plan and protocols. • Maintaining an effective respect to the investigation. 22
  • 23. MONITOR 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. 23
  • 24. ROLE 1. Director monitoring. 2. Medical monitoring . 3. Management monitoring. 4. Scientific monitoring. 24
  • 25. RESPONSIBILITY • Assign to appropriate protocols. • Review from activities as applicable. • Review protocol rules. •Advise protocol team on safety oversight. 25 • Evaluate and reviews safety reports. • Assist with pharmacovigilance activities.
  • 26. 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. 26
  • 27. ROLE 1. Project management. 2. Database design & build. 3. Data entry & validation. 4. Clinical trial data management. 5. Medicine and disease coding. 27
  • 28. CONT….. 6. Quality and metric reporting. 7. Statistical analysis plans and reports. 8. Validation programming. 9. Safety and efficacy summaries. 10. Final study report. 28
  • 29. 1. Evaluate feasibility. 2. Provide adequate, well manage staff. 3. Conduct study actives. 4. Manage processes. 5. Ensure that the solution are cost-effective. RESPONSIBILITY 29
  • 30. 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) Carlos, R.A., 2017. Improving Faculty Participation in Student Conduct Hearing Boards: A Gap Analysis (Doctoral dissertation, University of Southern California). 4) 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. 5)https://www.fda.gov/downloads/training/cdrhlearn/ucm176457.pdf. 6)Read more:http://www.businessdictionary.com /definition /role.htm.l 7) National Drug Policy and Authority Act 2000 Edition 8) R. Sridhar*, Ch. V. Hemanth and N. Durga Deepak CLINICAL TRIALS AND ROLE OF PHARMACIST REFERENCE 30
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