The document outlines the roles and responsibilities of various players in pharmacovigilance. It discusses the role and responsibilities of investigators in conducting clinical trials according to ethical principles and applicable regulations. It also describes the role of coordinators in managing clinical trials and ensuring IRB approval requirements are met. The document notes that sponsors are responsible for selecting qualified investigators and properly monitoring investigations. Monitors assist with safety activities like reviewing protocols and safety reports. Finally, contract research organizations manage clinical trial processes like data management and provide adequate staffing.

1. ROLES AND RESPONSIBILITIES
IN PHARMACOVIGILANCE
Presented By – Nikhil Ganesh Mudholkar
Class – M.pharm 1 st year 2 nd semester
Guide By – Shagufta Farooqui
Shri Sharda Bhavan Education Society’s
College -Nanded Pharmacy college, Nanded
2022-23

2. Contents :
1. INVESTIGATOR
2. COORDINATOR
3. SPONSOR
4. MONITOR
5. CONTRACT RESEARCH ORGANISATION
6. REFERENCE
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3. ■ Responsibilities -
The opportunity or ability to act independently and take decisions without
authorisation.
■ Role –
A prescribed or expected behaviour associated with a particular position or status in a
group, organization.
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4. 1. INVESTIGATOR
■ Role –
1. Follow ethical principles and standards.
2. Interaction for applicable federal, state and local regulatory authority.
3. Discipline in designing and conducting clinical trials for policies procedures.
4. Refer to section Good Clinical Practice ( GCP) Course for training requirements.
■ Responsibilities –
1. Conducting the trail , statement, protocol and applicable regulations.
2. Obtaining informed consent from all trial participants .
3. Maintaining proper records.
4. Managing all progress reports, safety reports, financial disclosure reports.
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5. 2. CO-ORDINATOR
■ Role –
1. Conduct of a research study.
2. Managing data and collecting biological specimens.
3. Preparing the institutional review board ( IRB) submission.
4. Writing the informed consent document, recruiting and consenting participants.
■ Responsibilities –
1. Provide regulatory, institutional, sponsor and protocol requirements for the study.
2. Ensure all studies have current IRB approval.
3. Complete with all IRB decisions, conditions and requirements.
4. Coordinate with other key research personnel.
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6. 3. SPONSOR
■ Role –
1. Financial
2. Reputation
3. Legal
■ Responsibilities –
1. Selecting and providing qualified investigators.
2. Ensuring proper monitoring of the investigation.
3. Ensuring conducted in accordance with the plan and protocols.
4. Maintaining an effective respect to the investigation.
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7. 4. Monitor
■ Role –
1. Director monitoring.
2. Medical monitoring.
3. Management monitoring.
4. Scientific monitoring.
■ Responsibilities –
1. Assist with pharmacovigilance activities.
2. Review protocol rules.
3. Advice protocol team on safety oversight.
4. Evaluate and reviews safety reports.
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8. 5. CONTRACT RESEARCH ORGANIZATION
■ Role –
1. Project management.
2. Database design and build.
3. Data entry and validation.
4. Clinical trail data management .
■ Responsibilities –
1. Evaluate feasibility.
2. Provide adequate, well manage staff.
3. Conduct study activities.
4. Manage processes.
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9. 1. World Health organization, 2004, A glossary of terms for community health care and
services for older persons.
2. Thorat, S.B., Banarjee, S.K., Gaikwad , D.D., Jadhav , S.L and Thorat, R.M.. Clinical
trail: a review. Int J pharm Sci kev Res. 1 , pp.101-106, 2010
3. Robert, B.L., Rickard, C.M., Foote, J. And McGrail , M.R., The best and worst aspects
of the ICU research coordinator role. Nursing in Critical Care, 11(3),pp,128-135. 2006
4. R .Sridhar ,Ch V. Hemanth and N. Durga Deepak CLINICAL TRIALS AND ROLE
OF PHARMACIST. pp.123-125,2011
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References :

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