Clinical trail team ( stake holders )

stake holders in clinical trail

1. Clinical trial team IRENE.V.R Ist M.PHARM PHARMACY PRACTICE 1

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 2

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 3

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) 5 SPONSOR/ CRO investigator STUDY SUBJECT IRB/ IEC REGULATORY AUTHORITY

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8. Chief responsibilities of stake holders : 8 slno stake holder Sponsor/ CRO Investigator R esponsibilities 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 1. 2.

9. 9 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 11

12. 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 ) 12

13. 13 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 14

15. 15 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 16

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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 20

21. 21 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

22. 22 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.

23. 23 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 24

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 Unexpected serious adverse event should be communicated to the licensing authority within 14 days and to the other investigator 25

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 27

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29. REFERENCE 1.Guruprasad mohantaTextbook of clinical research.2 nd edition2017.pharmaMed press;( 26-35 ). Philip Mirowski and Robert Van Hor.The Contract Research Organization and the Commercialization of Scientific Research ;2013 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 29

30. 30 THANK YOU