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    Informed Consent Process

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    sagarsexy0018
    The informed consent process involves providing patients with a consent form that describes the study purpose, risks, and benefits. The consent form is approved by the institutional review board and personalized at each site. Patients are given time to read the form, ask questions, and decide whether to participate by signing the form. Their consent must be obtained before starting any study treatments or procedures.

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    Informed Consent Process

    Uploaded by

    sagarsexy0018
    440 views1 page
    The informed consent process involves providing patients with a consent form that describes the study purpose, risks, and benefits. The consent form is approved by the institutional review board and personalized at each site. Patients are given time to read the form, ask questions, and decide whether to participate by signing the form. Their consent must be obtained before starting any study treatments or procedures.

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    Informed Consent Process[1]

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    The informed consent process involves providing patients with a consent form that describes the study purpose, risks, and benefits. The consent form is approved by the institutional review board and personalized at each site. Patients are given time to read the form, ask questions, and decide whether to participate by signing the form. Their consent must be obtained before starting any study treatments or procedures.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    440 views1 page

    Informed Consent Process

    Uploaded by

    sagarsexy0018
    The informed consent process involves providing patients with a consent form that describes the study purpose, risks, and benefits. The consent form is approved by the institutional review board and personalized at each site. Patients are given time to read the form, ask questions, and decide whether to participate by signing the form. Their consent must be obtained before starting any study treatments or procedures.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Informed Consent Process

    A Consent Form is provided by the sponsor


    with the study protocol or created by the site investigator.

    The Consent Form is personalized by each site, 1 Source documents must reflect
    adding local contact names and numbers. that consent was obtained before
    the start of study treatment and
    procedures.

    The Consent Form is approved for use 2 A copy of the signed consent form
    by the Institutional Review Board. must be kept at the site.

    3 All versions of approved consent


    forms must be kept in the site
    study file; only the current IRB
    Investigator or designated study personnel informs the patient
    approved version may be used to
    about the study purpose, risks, and potential benefits.
    consent new patients.

    The patient is allowed time to read the Consent Form,


    ask questions, and consider participation.

    The patient or legal representative signs and dates* the Consent Form.
    The sponsor and/or IRB may require additional signatures.

    The patient is given a copy of the Consent Form


    and study treatment and procedures can be started.

    *Date not required for Title 45 trials

    Informed Consent is an ongoing process.


    The patient should be provided with information throughout the study that might influence the patient’s decision to continue participation.

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