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  • Adverse Event Tracking Log: Subject Initials Subject ID# Page of

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    Praty
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    This document is an adverse event tracking log used in a clinical trial or research study. It collects information about any adverse events experienced by subjects, including the date of onset, description of the event, severity, whether it was serious or ongoing, treatment provided, and attribution to the study drug or device. The log also records the initials and date of the principal investigator to document their review.

    Исходное описание:

    adverse event drug safety

    Оригинальное название

    Pharmacovigilance

    Авторское право

    © © All Rights Reserved

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    This document is an adverse event tracking log used in a clinical trial or research study. It collects information about any adverse events experienced by subjects, including the date of onset, description of the event, severity, whether it was serious or ongoing, treatment provided, and attribution to the study drug or device. The log also records the initials and date of the principal investigator to document their review.

    Авторское право:

    © All Rights Reserved
    Скачайте в формате DOCX, PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    45 просмотров1 страница

    Adverse Event Tracking Log: Subject Initials Subject ID# Page of

    Загружено:

    Praty
    This document is an adverse event tracking log used in a clinical trial or research study. It collects information about any adverse events experienced by subjects, including the date of onset, description of the event, severity, whether it was serious or ongoing, treatment provided, and attribution to the study drug or device. The log also records the initials and date of the principal investigator to document their review.

    Авторское право:

    © All Rights Reserved
    Скачайте в формате DOCX, PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    из 1

    HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Commented [CDASH Std1]: Optional

    Investigator Identifier (CDASH Domain: Common)


    CDASH/SDTM Variable Name: INVID
    Commented [CDASH Std2]: Highly Recommended
    Subject Initials Subject ID# Page of Protocol/Study Identifier (CDASH Domain: Common)
    CDASH/SDTM Variable Name: STUDYID
    Commented [CDASH Std3]: Highly Recommended
    Adverse Event Tracking Log Check box if there were no adverse events to be recorded  Subject Identifier (CDASH Domain: Common)
    CDASH/SDTM Variable Name: SUBJID
    Commented [CDASH Std4]: Highly Recommended
    Insert question to ask participant (e.g. Were there any adverse events? Y/N) Site No (If Applicable) (CDASH Domain: Common)
    CDASH/SDTM Variable Name: SITEID

    Drug/Device
    Commented [CDASH Std5]: Optional

    Attribution5^
    Treatment3

    Attribution5
    Outcome1

    Expected
    Any AEs (CDASH Domain: AE)
    Reported

    PI Initials

    PI Initials
    Severity/
    Ongoing
    (Y or N)

    (Y or N)
    (Y or N)
    Serious

    Date of
    CDASH/SDTM Variable Name: AEYN

    Taken4
    Grade2

    Action
    Study
    Adverse Event**
    Date

    Start End Commented [CDASH Std14]: Recommended/Conditional

    AE
    (Select from Safety Severity (CDASH Domain: AE)
    # Adverse Event Description Profiler) Date Date CDASH/SDTM Variable Name: AESEV
    Commented [CDASH Std12]: Optional
    Ongoing (Y/N) (CDASH Domain: AE)
    CDASH Variable Name: AEONGO

    SDTM Variable Name: AEENRTPT ...


    Commented [CDASH Std15]: Recommended/Conditional
    Serious (Y/N) (CDASH Domain: AE) ...
    Commented [CDASH Std7]: Highly Recommended
    Visit Date (CDASH Domain: Common) ...
    Commented [CDASH Std13]: Highly Recommended
    Outcome (CDASH Domain: AE) ...
    Commented [CDASH Std17]: Highly Recommended
    Attribution/Relationship to study treatment (CDASH Domain: AE)...
    Commented [CDASH Std18]: Highly Recommended
    Action Taken (CDASH Domain: AE) ...
    Commented [CDASH Std16]: Optional
    Treatment (CDASH Domain: AE) ...
    # - AE number. “1” indicates the first adverse event documented on the form, 2 = the second, etc. If the adverse event changes in severity, enter it as a separate adverse event row
    on the paper form using the same AE number as the one that ended. Commented [CDASH Std6]: Optional
    Line # (Unique per AE) (CDASH Domain: AE) ...
    **look up corresponding AE at: https://safetyprofiler-ctep.nci.nih.gov/
    Commented [CDASH Std8]: Highly Recommended
    Action Taken4 Attribution/ AE Description (CDASH Domain: AE) ...
    Outcome1 Severity/Grade2 AE Treatment3 with Study Intervention Relatedness5 Commented [Notes9]:
    0 – Fatal 1 – Mild 0 – None 0 – None 0 – Definite •Record only one diagnosis, sign or symptom per line (e.g., nausea...
    1 – Not recovered/not resolved 2 – Moderate 1 – Medication(s) 1 – Interrupted 1 – Probable
    2 – Recovered w/sequelae 3 – Severe 2 – Non-medication TX 2 – Discontinued 2 – Possible Commented [CDASH Std10]: Highly Recommended
    3 – Recovered w/o sequelae 4 – Life Threatening 3 – Dose reduced 3 – Unlikely Start Date (CDASH Domain: AE) ...
    4 – Recovering/Resolving 5 – Death (Fatal) 4 – Dose increased 4 – Unrelated Commented [CDASH Std11]: Highly Recommended
    5 – Not Applicable ^5 – Not Applicable (did not receive intervention) End Date (CDASH Domain: AE) ...

    Form Number Version Date: 09/05/2018

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