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    ROLE of Clinical Research Associate

    Uploaded by

    siri
    The document outlines the key responsibilities of sponsors, investigators, and clinical research associates (CRAs) in clinical trials. Sponsors are responsible for initiating, financing, and managing trials. Their responsibilities include trial design, monitoring, reporting adverse events, and compiling clinical study reports. Investigators oversee trials at individual sites and are responsible for informed consent, complying with protocols, and reporting safety issues. CRAs communicate between sponsors and investigators. Their responsibilities include selecting investigators, conducting pre-study, initiation and routine monitoring visits to ensure compliance and data quality.

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    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd

    ROLE of Clinical Research Associate

    Uploaded by

    siri
    497 views25 pages
    The document outlines the key responsibilities of sponsors, investigators, and clinical research associates (CRAs) in clinical trials. Sponsors are responsible for initiating, financing, and managing trials. Their responsibilities include trial design, monitoring, reporting adverse events, and compiling clinical study reports. Investigators oversee trials at individual sites and are responsible for informed consent, complying with protocols, and reporting safety issues. CRAs communicate between sponsors and investigators. Their responsibilities include selecting investigators, conducting pre-study, initiation and routine monitoring visits to ensure compliance and data quality.

    Original Description:

    GCP-WHO guidelines

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    The document outlines the key responsibilities of sponsors, investigators, and clinical research associates (CRAs) in clinical trials. Sponsors are responsible for initiating, financing, and managing trials. Their responsibilities include trial design, monitoring, reporting adverse events, and compiling clinical study reports. Investigators oversee trials at individual sites and are responsible for informed consent, complying with protocols, and reporting safety issues. CRAs communicate between sponsors and investigators. Their responsibilities include selecting investigators, conducting pre-study, initiation and routine monitoring visits to ensure compliance and data quality.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    497 views25 pages

    ROLE of Clinical Research Associate

    Uploaded by

    siri
    The document outlines the key responsibilities of sponsors, investigators, and clinical research associates (CRAs) in clinical trials. Sponsors are responsible for initiating, financing, and managing trials. Their responsibilities include trial design, monitoring, reporting adverse events, and compiling clinical study reports. Investigators oversee trials at individual sites and are responsible for informed consent, complying with protocols, and reporting safety issues. CRAs communicate between sponsors and investigators. Their responsibilities include selecting investigators, conducting pre-study, initiation and routine monitoring visits to ensure compliance and data quality.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 25
    At a glance
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    The key roles and responsibilities of a sponsor, investigator, CRA and clinical trial process were discussed.

    A sponsor is responsible for initiating, managing and financing clinical trials. Key sponsor responsibilities include quality assurance, trial design, selection of investigators, safety monitoring and providing study reports.

    An investigator is responsible for proper conduct of a clinical trial at their site. Key investigator responsibilities include qualifications, permitting monitoring, having adequate resources and complying with GCP guidelines.

    Responsibilities of Sponsor,

    Investigator and Monitor

    1
    Learning Objective

    Roles and Responsibilities of the

     Sponsor

     Investigator

     Clinical research associate

     Clinical research coordinator

    2
    Key Players in a Clinical Trial

    CRA

    Investigator Patient

    Clinical
    Trial

    Regulatory Ethics
    Authorities Committee

    Sponsor
    3
    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

    4
    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

    5
    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

    6
    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

    7
    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

    8
    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.

    9
    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

    10
    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

    11
    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

    12
    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

    13
    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.

    14
    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

    15
    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’

    16
    CRA’s Responsibilities

    Feasibility of trial Recruiting Investigators

    Not acceptable Pre-Study Visits

    Acceptable Site Initiation Visits

    Routine Monitoring Visits

    Site Close Out Visits

    17
    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

    18
    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

    19
    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

    20
    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

    21
    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

    22
    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

    23
    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

    24
    Thank you

    25

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