Responsibilities of Sponsor, Investigator and Monitor

1. Responsibilities of Sponsor, Investigator and Monitor

2. Sponsor Investigator Clinical research associate Clinical research coordinator Learning ObjectiveRoles and Responsibilities of the

3. Key Players in a Clinical Trial CRA Patient Investigator Clinical Trial Regulatory Authorities Ethics Committee Sponsor

4. Sponsor • Who is Sponsor? An individual, company, institution, or organisation which takes responsibility for the • Initiation • Management • Financing of a clinical trial. ICH E6, 1.53

5. Sponsor’s Responsibilities • Quality Assurance & Quality Control • To ensure that trials are conducted & data are generated, documented & reported in compliance with the protocol, GCP & applicable regulatory requirements. • To ensure direct access to trial related data by the sponsor or inspector (auditor). • Medical Expertise • Should designate qualified medical personnel to advise trial related medical questions

6. Sponsor’s Responsibilities • Trial Design • Trial management, data handling, record keeping • Investigator selection • Compensation to Subjects & Investigators • Provide insurance or indemnity to subjects or investigator / institution • Financing • Financial written agreement between sponsor & investigator • Application to regulatory body for permission to conduct the trial

7. Sponsor’s Responsibilities • Information on investigational product • Ensure that sufficient safety & efficacy data from non clinical studies are available to support human exposure • Manufacturing & packaging of IP • Ensure that IP is manufactured as per applicable GMP and appropriately coded, labeled & packaged

8. Sponsor’s Responsibilities • Safety information • Responsible for ongoing safety evaluation of IP • Monitoring & Audit • To ensure that conduct of trial is in accordance with approved protocol • Clinical Study Reports • To prepare and provide reports to regulatory authorities

9. Investigator • Who is Investigator? A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called as Principal Investigator.

10. Investigator’s Responsibilities • Qualifications and Agreements • Should be qualified by education, training and experience to assume responsibility for the proper conduct of trial • Permit monitoring and auditing by sponsor and inspection by regulatory authority • Adequate Resources • Should be able to demonstrate a potential for recruiting the required number of suitable subjects • Sufficient time, adequate number of qualified staff and adequate facilities

11. Investigator’s Responsibilities • Medical Care of Trial Subjects • Responsible for all trial related medical decisions and ensure that adequate medical care is provided to a subject for any AE related to trial • Communication with IRB/IEC • Written and dated approval from IRB/IEC before initiating the trial • Keep IRB/IEC apprise of all deviations, SAEs & progress during the study

12. Investigator’s Responsibilities • Compliance with Protocol • Conduct the study according to protocol • No deviation from protocol without agreement by the sponsor & prior review/approval from IRB/IEC • Investigational Product • IP accountability & maintenance of records of the product’s delivery to the site, inventory at site, use by the subject, return to sponsor or destruction. • Storage & use of IP according to protocol

13. Investigator’s Responsibilities • Informed Consent of Study Subjects • Provide IRB/IEC approved written informed consent form to subject • Should not coerce or unduly influence subjects to participate • Language of informed consent form should be nontechnical and understandable to the subject • Subject should be given ample time and opportunity to ask questions • Subject should sign and personally date informed consent form prior to initiation of study procedures

14. Investigator’s Responsibilities • Records & Reports • Accuracy, completeness, legibility & timelines of the data reported in CRF • Progress Reports • Written summaries of status of the trial to IRB/IEC annually or as required by IRB/IEC • Safety Reporting • All SAEs should be reported to sponsor immediately • AE or lab abnormalities identified as critical in protocol should be notified to sponsor.

15. Investigator’s Responsibilities • Premature Termination or Suspension of Trial • Inform subjects, ensure appropriate therapy & follow up of the subjects • If investigator or sponsor terminates/suspends trial – inform institution & IRB/IEC • Final Reports • Provide summary of trial outcome to institution and IRB/IEC

16. CRA / Monitor Who is CRA? • Acts as main line of communication between sponsor and the investigator. • Visit & work with sites on behalf of sponsor • Performs variety of clinical operations & monitoring activities • Often called as ‘Clinical Monitor’ or ‘Study Monitor’

17. Recruiting Investigators Pre-Study Visits Site Initiation Visits Routine Monitoring Visits Site Close Out Visits CRA’s Responsibilities Feasibility of trial Not acceptable Acceptable

18. CRA’s Responsibilities • Evaluating & Selecting the investigators • The Monitor is responsible for selecting the investigator/institution. Each investigator should be qualified by • training • experience and should have • adequate resources to properly conduct the trial for which the investigator is selected

19. CRA’s Responsibilities • Pre Study Visit (site selection visit) • Conducted at a potential research site • Assess the investigator’s experience, staff, facility and potential patient population • Introduce the study & obligations to the potential investigator & staff

20. CRA’s Responsibilities • Site Initiation Visit • Conducted at a confirmed research site • Verify the confirmed investigator’s experience, staff, facility and potential patient population • Detail the study & obligations to the potential investigator & staff • Collect all essential documents before this visit

21. CRA’s Responsibilities • Routine Monitoring Visit • CRA’s main activity – study monitoring • Purpose of monitoring: • rights & well being of subjects are protected • reported data are accurate, complete & verifiable from source documents • trial conduct is in compliance with protocol, GCP & applicable regulatory requirements

22. CRA’s Responsibilities • Routine Monitoring Visit • Review IP handling, storage conditions, receipt, use, return and disposition • Review all informed consent forms • Review protocol compliance • Review CRFs, source documents, site file • Review AEs/SAEs • Review facilities, resources, staffing • Address questions and/or concerns

23. CRA’s Responsibilities • Site Close out Visit • Site close out visit is conducted when • Study is complete & finished • Enrollment has stopped • All subjects have completed their study related activities • Data are complete & correct • Final IP accountability is done

24. CRA’s Responsibilities • Site Close out Visit • Site close out visit is conducted to • Retrieve all appropriate study supplies • Verify that study documentation is complete & accurate • Ensure that site is in compliance with regulatory & GCP guidelines

25. Thank you