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    This document is a serious adverse event report form used to document any serious adverse events experienced by study participants. It requests information such as the participant ID and initials, date of event onset, description of the adverse event, any actions taken like hospitalization or stopping the study drug, why the event was considered serious, and the assessed relationship to the study drug. A follow up section allows documenting any additional relevant clinical information.

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    Serious Adverse Events a e 040202

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    This document is a serious adverse event report form used to document any serious adverse events experienced by study participants. It requests information such as the participant ID and initials, date of event onset, description of the adverse event, any actions taken like hospitalization or stopping the study drug, why the event was considered serious, and the assessed relationship to the study drug. A follow up section allows documenting any additional relevant clinical information.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    4 views2 pages

    Report Serious Adverse Events

    Uploaded by

    ark1974
    This document is a serious adverse event report form used to document any serious adverse events experienced by study participants. It requests information such as the participant ID and initials, date of event onset, description of the adverse event, any actions taken like hospitalization or stopping the study drug, why the event was considered serious, and the assessed relationship to the study drug. A follow up section allows documenting any additional relevant clinical information.

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    of 2

    Date Entered:____________ Staff Initials:____________

    COMBINE Serious Adverse Event Report (SAE ver A.)


    Center Participant # Participant Initials Week Sequence

    0 1
    Date Staff ID

    /
    mo. da.

    /
    yr.

    INSTRUCTIONS: Complete a Serious Adverse Event Report whenever a study participant experiences a serious adverse event. A serious adverse event is defined as an experience that is known with certainty or suspected with good reason to constitute a threat to life or to cause severe or permanent damage. Serious adverse events have one or more of the following characteristics: require in-patient, or prolonged hospitalization; result in persistent or significant disability/incapacity; result in death; are life-threatening; are a congenital anomaly/birth defect. Drug misuse, drug overdose, and malignant tumors should also be regarded as serious, even if they do not result in the outcomes mentioned above. FAX this SAE report to the Coordinating Center (919-962-3265) and NIAAA (301-443-8774) within 24 hours of onset of a serious adverse experience. The PI should notify Lipha immediately by telephone at 1-978-542-1904 and the form should be faxed to 1-978-542-1950. 1. 2. a. Gender: Female Male b. Age:

    Start of Treatment: month

    /
    day

    /
    year

    3.

    Onset Date of SAE: month

    /
    day

    /
    year

    4. 5.

    Serious Adverse Experience (describe Sign/Symptom): __________________________________________________ Action Taken (check all that apply): a) Medication b) Dose Reduced c) Study Drug Temporarily Stopped (Date stopped: ____/____/_____ ) d) Study Drug Permanently Stopped (Date stopped: ____/____/_____ ) e) Hospitalized month day year f) Other Specify: ____________________________

    Yes No

    6.

    Why was the event serious? (check one): 1) Fatal event 2) Life-threatening event 3) Disabling/Incapacitating 4) Inpatient hospitalization

    5) Hospitalization prolonged 6) Congenital anomaly 7) Cancer 8) Result of an overdose 9) Other ________________________ 1) Not related 2) Possibly related 3) Not assessable

    7.

    Relationship to drug (check one):

    SAE_5 (4/02/02)

    Page 1 of 2

    COMBINE Serious Adverse Event Report (SAE ver A.)


    Center Participant # Participant Initials Week Sequence

    0 1
    Date Staff ID

    /
    mo. da.

    /
    yr.

    INSTRUCTIONS: Please indicate date and any specific follow up events or other clinical information relevant to the SAE reported on the previous page.

    Signature:__________________________________________

    SAE_5 (4/02/02)

    page 2 of 2

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