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    Guide To The Clinical Research Associate (CRA) Role: Chapter Ii

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    siri
    The document provides an overview of the clinical research associate (CRA) role. It states that CRAs set up, monitor, and complete clinical trials conducted by pharmaceutical companies or contract research organizations. Some of the main responsibilities of CRAs include undergoing training in clinical trial regulations and procedures, identifying investigators and sites, preparing consent forms, facilitating regulatory submissions, setting up study sites, monitoring sites regularly, verifying data, assisting with problems, and closing down sites at the end of trials. More senior CRAs may take on additional responsibilities like developing protocols, designing forms, and preparing reports and publications.

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    Guide To The Clinical Research Associate (CRA) Role: Chapter Ii

    Uploaded by

    siri
    15 views6 pages
    The document provides an overview of the clinical research associate (CRA) role. It states that CRAs set up, monitor, and complete clinical trials conducted by pharmaceutical companies or contract research organizations. Some of the main responsibilities of CRAs include undergoing training in clinical trial regulations and procedures, identifying investigators and sites, preparing consent forms, facilitating regulatory submissions, setting up study sites, monitoring sites regularly, verifying data, assisting with problems, and closing down sites at the end of trials. More senior CRAs may take on additional responsibilities like developing protocols, designing forms, and preparing reports and publications.

    Original Description:

    CRA ROLEs

    Original Title

    ROLE of Clinical Research Associate

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    The document provides an overview of the clinical research associate (CRA) role. It states that CRAs set up, monitor, and complete clinical trials conducted by pharmaceutical companies or contract research organizations. Some of the main responsibilities of CRAs include undergoing training in clinical trial regulations and procedures, identifying investigators and sites, preparing consent forms, facilitating regulatory submissions, setting up study sites, monitoring sites regularly, verifying data, assisting with problems, and closing down sites at the end of trials. More senior CRAs may take on additional responsibilities like developing protocols, designing forms, and preparing reports and publications.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    15 views6 pages

    Guide To The Clinical Research Associate (CRA) Role: Chapter Ii

    Uploaded by

    siri
    The document provides an overview of the clinical research associate (CRA) role. It states that CRAs set up, monitor, and complete clinical trials conducted by pharmaceutical companies or contract research organizations. Some of the main responsibilities of CRAs include undergoing training in clinical trial regulations and procedures, identifying investigators and sites, preparing consent forms, facilitating regulatory submissions, setting up study sites, monitoring sites regularly, verifying data, assisting with problems, and closing down sites at the end of trials. More senior CRAs may take on additional responsibilities like developing protocols, designing forms, and preparing reports and publications.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 6

    CHAPTER‐II

    Guide  to the  Clinical  Research  Associate  
    (CRA)  Role

    by:
    j. jayasutha
    lecturer
    department of pharmacy practice
    Srm college of pharmacy
    srm university
    CRA MEANS

    9 A clinical research associate (CRA) sets up,


    monitors and completes clinical trials
    conducted by pharmaceutical companies or
    contract research organisations (CROs) on their
    behalf.

    9 CRAs can also be known as ‘Trial Monitors’ 
    and ‘Clinical Research Scientists’.
    •Undergo regular training in regulations, standard 
    operating procedures, guidelines and trial protocols and 
    procedures.

    •Identify and  pre‐screen potential  investigators and their 
    facilities.

    •Prepare  and/or customize patient information and 
    consent forms.

    •Complete  and/or co‐ordinate ethics  submissions  in 
    partnership  with  selected  sites.

    •Negotiate trial budgets/contract  with  sites.

    •Facilitate regulatory authority clinical  trial 
    applications/notifications.
    •Set  up the study centres with  appropriate trial materials  
    and training.

    •Assist at  investigator meetings.

    •Help  study sites develop and  implement recruitment  
    plans.

    •Visit  study sites regularly to monitor the study.

    •Check that data entered onto data collection forms called 
    case report forms (CRFs) is complete, makes sense and is 
    consistent with patient clinical notes (a process known as 
    source data/document verification (SDV)).

    •Collect completed CRFs from  study sites.
    •Writing reports for all communications  and visits with 
    study sites; 
    •Facilitate expedited safety reporting to and from  sites; 

    •Help sites solve any problems they may have with 
    recruiting and retaining patients, conducting the study, 
    collecting data, etc.

    •Assist in some data management activities, such as 
    reviewing and helping site staff answer queries on the 
    data collected; 

    •Spend considerable time filing  and collating trial 
    documentation and reports; 

    •Complete  drug accountability for all trial supplies  ; 

    •Closing down study sites  and archive  documentation at 
    the  end of trials. 
    As CRAs develop in skill and experience, they will take 
    on more responsibility for the successful set‐up and 
    conduct of clinical trials.

    Senior CRAs may also become involved in:
    Developing  and  writing trial protocols (outlining 
    the purpose and methodology of  a trial);
    •presenting trial protocols to a steering committee; 
    •designing  data collection forms, known  as case record forms 
    (CRFs); 
    •preparing  and monitoring trial  budgets; 
    •dealing with external vendors, such as  CRO’s. 
    •discussing results  with a medical statistician, who usually writes 
    technical trial reports; 
    •archiving study documentation  and correspondence; 
    •preparing final reports and occasionally manuscripts for 
    publication. 

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