1. Responsibilities of Sponsor, Investigator and Monitor

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

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

18. CRA’s Responsibilities…cont’d
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…cont’d
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…cont’d
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…cont’d
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…cont’d
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…cont’d
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…cont’d
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