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    Mounika Kamarapu presented an overview of clinical study tasks and activities to Dr. Mukty Sinha. The presentation discussed the keys for clinical study tasks which include developing the clinical protocol and study materials. It also covered discussing key tasks and activities, importance of managing tasks, using a spreadsheet to track activities, and roles of the clinical research team which includes managers, associates, data personnel, biostatisticians, IRB coordinators and regulatory specialists. The flow of the seminar was to discuss these various aspects of clinical studies and their management.

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    medical devices development

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    Mounika Kamarapu presented an overview of clinical study tasks and activities to Dr. Mukty Sinha. The presentation discussed the keys for clinical study tasks which include developing the clinical protocol and study materials. It also covered discussing key tasks and activities, importance of managing tasks, using a spreadsheet to track activities, and roles of the clinical research team which includes managers, associates, data personnel, biostatisticians, IRB coordinators and regulatory specialists. The flow of the seminar was to discuss these various aspects of clinical studies and their management.

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    9 views10 pages

    Medical Device Clinical Tasks by Kamarapu Mounika

    Uploaded by

    kamarapu mounika
    Mounika Kamarapu presented an overview of clinical study tasks and activities to Dr. Mukty Sinha. The presentation discussed the keys for clinical study tasks which include developing the clinical protocol and study materials. It also covered discussing key tasks and activities, importance of managing tasks, using a spreadsheet to track activities, and roles of the clinical research team which includes managers, associates, data personnel, biostatisticians, IRB coordinators and regulatory specialists. The flow of the seminar was to discuss these various aspects of clinical studies and their management.

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    © All Rights Reserved
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    of 10

    AN OVERVIEW OF CLINICAL

    STUDY TASKS AND ACTIVITIES

    PRESENTED BY
    MOUNIKA KAMARAPU
    (NIPERA1618MD04)
    MEDICAL DEVICES M.S (PHARMA)
    SUBMITED TO:
    DR.MUKTY SINHA (MEDICAL
    DEVICES)

    FLOW OF SEMINAR...
    What are the Keys for clinical study

    tasks and activities?


    Discussion of key tasks and activities.
    Importance of management of key
    clinical tasks and activities.
    Spread sheet for managing clinical
    study activities.
    Clinical research team.

    What are the keys for clinical


    study tasks and activities?
    Development of clinical protocol and study materials.

    CONTINUE....
    Fist patient in.

    MANAEMENT OF KEY CLINICAL


    TASKS AND ACTIVITIES

    Spread sheet for


    managing clinical study
    activities.
    Activity/tas Planned
    k
    date
    Protocol
    development
    FDA
    approval for
    the study
    IRB approval
    for the study
    Clinical
    report

    Completion comments
    data

    THE CLINICAL RESERCH TEAM


    1. Clinical study manager.
    2. Clinical research associates.
    3. Data management personnel.
    4. Biostatistician.
    5. IRB coordinator.
    6. Regulatory specialist.

    THIS CHAPTER CONCLUSION....

    REFERENCE BOOK
    Design ,execution and

    management of medical devices


    clinical trials Author SHLAH
    M.ABDEL-ALEEM.

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