Responsibilities of Sponsor, Investigator and Monitor

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

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

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

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

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

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

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

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.

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

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

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

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

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.

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

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’

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

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

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

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

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

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

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

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

Thank you