ID

16998

Beschreibung

ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Serious Adverse Event (SAE) Report Form. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.

Link

http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx

Stichworte

  1. 19.08.16 19.08.16 -
Hochgeladen am

19. August 2016

DOI

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Creative Commons BY-NC 3.0

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    Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta

    Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta

    General Information
    Beschreibung

    General Information

    Protocol Title
    Beschreibung

    Protocol Title

    Datentyp

    text

    Protocol Number
    Beschreibung

    Protocol Number

    Datentyp

    integer

    Site Number
    Beschreibung

    Site Number

    Datentyp

    integer

    Pt_ID
    Beschreibung

    Pt_ID

    Datentyp

    integer

    SAE Report Form
    Beschreibung

    SAE Report Form

    1. SAE Start Date
    Beschreibung

    1. SAE Start Date

    Datentyp

    date

    2. SAE Stop Date
    Beschreibung

    2. SAE Stop Date

    Datentyp

    date

    3. Location of serious adverse event
    Beschreibung

    3. Location of serious adverse event

    Datentyp

    text

    4. Was this an unexpected adverse event?
    Beschreibung

    4. Was this an unexpected adverse event?

    Datentyp

    boolean

    5. Brief description of participant(s) with no personal identifiers: Sex
    Beschreibung

    5. Brief description of participant(s) with no personal identifiers

    Datentyp

    text

    5. Brief description of participant(s) with no personal identifiers: Age
    Beschreibung

    5. Brief description of participant(s) with no personal identifiers

    Datentyp

    integer

    6. Brief description of the nature of the serious adverse event
    Beschreibung

    6. Brief description of the nature of the serious adverse event

    Datentyp

    text

    7. Category of the serious adverse event
    Beschreibung

    7. Category of the serious adverse event

    Datentyp

    text

    If Other, please specify
    Beschreibung

    If Other, please specify

    Datentyp

    text

    8. Intervention type: Medication or Nutritional Supplement
    Beschreibung

    8. Intervention type

    Datentyp

    boolean

    Please specify
    Beschreibung

    Specification

    Datentyp

    text

    Intervention type: Device
    Beschreibung

    Intervention type

    Datentyp

    boolean

    Please specify
    Beschreibung

    Specification

    Datentyp

    text

    Intervention type: Surgery
    Beschreibung

    Intervention type

    Datentyp

    boolean

    Please specify
    Beschreibung

    Specification

    Datentyp

    text

    Intervention type: Behavioral/ Life Style
    Beschreibung

    Intervention type

    Datentyp

    boolean

    Please specify
    Beschreibung

    Specification

    Datentyp

    text

    9. Relationship of intervention
    Beschreibung

    9. Relationship of intervention

    Datentyp

    text

    10. Was study intervention discontinued due to event?
    Beschreibung

    10. Was study intervention discontinued due to event?

    Datentyp

    boolean

    11. What medications or other steps were taken to treat serious adverse event?
    Beschreibung

    11. What medications or other steps were taken to treat serious adverse event?

    Datentyp

    text

    12. List any relevant tests, laboratory data, history, including preexisting medical conditions
    Beschreibung

    12. List any relevant tests, laboratory data, history, including preexisting medical conditions

    Datentyp

    text

    13. Type of report
    Beschreibung

    13. Type of report

    Datentyp

    text

    Signature of Principal Investigator
    Beschreibung

    Signature of Principal Investigator

    Datentyp

    text

    Date
    Beschreibung

    Date

    Datentyp

    date

    Ähnliche Modelle

    Serious Adverse Event (SAE) Report Form: CRF QMCR University of Alberta

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    General Information
    Protocol Title
    Item
    Protocol Title
    text
    Protocol Number
    Item
    Protocol Number
    integer
    Site Number
    Item
    Site Number
    integer
    Pt_ID
    Item
    Pt_ID
    integer
    Item Group
    SAE Report Form
    1. SAE Start Date
    Item
    1. SAE Start Date
    date
    2. SAE Stop Date
    Item
    2. SAE Stop Date
    date
    3. Location of serious adverse event
    Item
    3. Location of serious adverse event
    text
    4. Was this an unexpected adverse event?
    Item
    4. Was this an unexpected adverse event?
    boolean
    Item
    5. Brief description of participant(s) with no personal identifiers: Sex
    text
    Code List
    5. Brief description of participant(s) with no personal identifiers: Sex
    CL Item
    F (1)
    CL Item
    M (2)
    5. Brief description of participant(s) with no personal identifiers
    Item
    5. Brief description of participant(s) with no personal identifiers: Age
    integer
    6. Brief description of the nature of the serious adverse event
    Item
    6. Brief description of the nature of the serious adverse event
    text
    Item
    7. Category of the serious adverse event
    text
    Code List
    7. Category of the serious adverse event
    CL Item
    death - date:____ (1)
    CL Item
    life-threatening (2)
    CL Item
    hospitalization-initial or prolonged (3)
    CL Item
    disability/incapacity (4)
    CL Item
    congenital anomaly / birth defect (5)
    CL Item
    required intervention to prevent permanent impairment  (6)
    CL Item
    Other (7)
    If Other, please specify
    Item
    If Other, please specify
    text
    8. Intervention type
    Item
    8. Intervention type: Medication or Nutritional Supplement
    boolean
    Specification
    Item
    Please specify
    text
    Intervention type
    Item
    Intervention type: Device
    boolean
    Specification
    Item
    Please specify
    text
    Intervention type
    Item
    Intervention type: Surgery
    boolean
    Specification
    Item
    Please specify
    text
    Intervention type
    Item
    Intervention type: Behavioral/ Life Style
    boolean
    Specification
    Item
    Please specify
    text
    Item
    9. Relationship of intervention
    text
    Code List
    9. Relationship of intervention
    CL Item
    unrelated (clearly not related to the intervention) (1)
    CL Item
    possible (may be related to intervention) (2)
    CL Item
    definite (clearly related to intervention) (3)
    10. Was study intervention discontinued due to event?
    Item
    10. Was study intervention discontinued due to event?
    boolean
    11. What medications or other steps were taken to treat serious adverse event?
    Item
    11. What medications or other steps were taken to treat serious adverse event?
    text
    12. List any relevant tests, laboratory data, history, including preexisting medical conditions
    Item
    12. List any relevant tests, laboratory data, history, including preexisting medical conditions
    text
    Item
    13. Type of report
    text
    Code List
    13. Type of report
    CL Item
    initial (1)
    CL Item
    follow-up (2)
    CL Item
    final (3)
    Signature of Principal Investigator
    Item
    Signature of Principal Investigator
    text
    Date
    Item
    Date
    date

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