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    Introduction To The Role of CRA

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    Herry Sinambela
    The document discusses the role of clinical research associates and good clinical practice in clinical trials. It outlines the goals of good clinical practice which are to protect subjects and ensure credible and accurate data and results. It also discusses essential documents required before, during, and after conducting clinical trials.

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    Introduction To The Role of CRA

    Uploaded by

    Herry Sinambela
    11 views14 pages
    The document discusses the role of clinical research associates and good clinical practice in clinical trials. It outlines the goals of good clinical practice which are to protect subjects and ensure credible and accurate data and results. It also discusses essential documents required before, during, and after conducting clinical trials.

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    Introduction to The Role of CRA

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    The document discusses the role of clinical research associates and good clinical practice in clinical trials. It outlines the goals of good clinical practice which are to protect subjects and ensure credible and accurate data and results. It also discusses essential documents required before, during, and after conducting clinical trials.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    11 views14 pages

    Introduction To The Role of CRA

    Uploaded by

    Herry Sinambela
    The document discusses the role of clinical research associates and good clinical practice in clinical trials. It outlines the goals of good clinical practice which are to protect subjects and ensure credible and accurate data and results. It also discusses essential documents required before, during, and after conducting clinical trials.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 14

    Introduction to The Role of

    Clinical Research Associate


    Nurul Hidayah
    March 7, 2022
    Clinical Research
    Any planned experiment in human subjects with the aim to discover or
    verify the clinical or pharmacological effects (efficacy, safety, kinetics)
    of an investigational product (drug, medical device, diagnostic
    tools/materials).
    Good Clinical Practice
    An international ethical and scientific quality standard for designing,
    recording and reporting trials that involve the participation of human
    subjects.
    The Goals of GCP
    • To protect the rights, safety, wellbeing, integrity and confidentiality of
    subjects.
    • To assure that data and trial results are credible and accurate.
    Cara Uji Klinik
    yang Baik (CUKB)
    Before CT Conduct

    Essential Documents in Clinical Trial (1)

    INVESTIGATOR SITE FILE (ISF)

    TRIAL MASTER FILE (TMF)


    Before CT Conduct

    Essential
    Documents
    in Clinical
    Trial (2)
    Before CT Conduct

    Essential
    Documents
    in Clinical
    Trial (3)
    Before CT Conduct

    Essential
    Documents
    in Clinical
    Trial (4)
    During CT Conduct

    Essential
    Documents
    in Clinical
    Trial (5)
    During CT Conduct

    Essential
    Documents
    in Clinical
    Trial (6)
    During CT Conduct

    Essential
    Documents
    in Clinical
    Trial (7)
    After CT Conduct

    Essential
    Documents
    in Clinical
    Trial (8)
    THANK YOU

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