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ID

18749

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Serious Adverse Event Part I. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Keywords

Versions (2)
  1. 7/27/16 7/27/16 -
  2. 11/18/16 11/18/16 -
Uploaded on

November 18, 2016

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License

Creative Commons BY-NC 3.0
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    Serious Adverse Event Part I: CRF Wisconsin Madison

    English

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 forms  
    Header
    Description

    Header

    PI Name
    Description

    PI Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1521895
    Protocol or IRB Number
    Description

    Protocol or IRB Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348563
    Protocol Short Title
    Description

    Protocol Short Title

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C1705824
    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Subject ID
    Description

    Subject ID

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Serious Adverse Event
    Description

    Serious Adverse Event

    Event Start Date
    Description

    Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Event End Date
    Description

    Event End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    Date Reported
    Description

    Date Reported

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0700287
    Reported to Research Staff Bv
    Description

    Reported to Research Staff Bv

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0700287
    UMLS CUI [1,2]
    C2986262
    Death Date (if applicable)
    Description

    Death Date (if applicable)

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Death Occurred
    Description

    Death Occurred

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1306577
    UMLS CUI [1,2]
    C2745955
    Did the SAE occur at your site or at a site for which the PI is responsible?
    Description

    SAE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0678341
    SAE Description/Narrative
    Description

    SAE Description/Narrative

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0678257
    Treating Physician Comments (if applicable)
    Description

    Treating Physician Comments (if applicable)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1710470
    PI Comments
    Description

    PI Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C1521895
    Outcome
    Description

    Outcome

    Data type

    text

    Consent Form Change Required?
    Description

    Consent Form Change Required?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009797
    UMLS CUI [1,2]
    C0392747
    SAE Classification: Fatal (resulted in death)
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C1302234
    SAE Classification: A life-threatening occurrence
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C2826244
    SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C0019993
    SAE Classification: Results in persistent or significant disability/incapacity
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C0231170
    SAE Classification: Results in congenital anomaly/birth defect
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C0000768
    SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C4035998
    SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
    Description

    SAE Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737
    UMLS CUI [1,2]
    C3845751
    UMLS CUI [2]
    C0683675
    UMLS CUI [3]
    C0870486
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    Similar models

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    PI Name
    Item
    PI Name
    text
    C0027365 (UMLS CUI [1,1])
    C1521895 (UMLS CUI [1,2])
    Protocol or IRB Number
    Item
    Protocol or IRB Number
    integer
    C2348563 (UMLS CUI [1])
    Protocol Short Title
    Item
    Protocol Short Title
    text
    C2348563 (UMLS CUI [1,1])
    C1705824 (UMLS CUI [1,2])
    Subject Initials
    Item
    Subject Initials
    text
    C2986440 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Serious Adverse Event
    Event Start Date
    Item
    Event Start Date
    date
    C2697888 (UMLS CUI [1])
    Event End Date
    Item
    Event End Date
    date
    C2697886 (UMLS CUI [1])
    Date Reported
    Item
    Date Reported
    date
    C0011008 (UMLS CUI [1,1])
    C0700287 (UMLS CUI [1,2])
    Reported to Research Staff Bv
    Item
    Reported to Research Staff Bv
    text
    C0700287 (UMLS CUI [1,1])
    C2986262 (UMLS CUI [1,2])
    Death Date (if applicable)
    Item
    Death Date (if applicable)
    date
    C1148348 (UMLS CUI [1])
    Item
    Death Occurred
    text
    C1306577 (UMLS CUI [1,1])
    C2745955 (UMLS CUI [1,2])
    Death Occurred
    Code List
    Death Occurred
    CL Item
    Within 24 hours of investigational therapy  (1)
    CL Item
    Within 7 days of investigational therapy  (2)
    CL Item
    Within 30 days of investigational therapy  (3)
    CL Item
    After 30 days of investigational therapy (4)
    SAE
    Item
    Did the SAE occur at your site or at a site for which the PI is responsible?
    boolean
    C1519255 (UMLS CUI [1,1])
    C0678341 (UMLS CUI [1,2])
    SAE Description/Narrative
    Item
    SAE Description/Narrative
    text
    C1519255 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Treating Physician Comments (if applicable)
    Item
    Treating Physician Comments (if applicable)
    text
    C0947611 (UMLS CUI [1,1])
    C1710470 (UMLS CUI [1,2])
    PI Comments
    Item
    PI Comments
    text
    C0947611 (UMLS CUI [1,1])
    C1521895 (UMLS CUI [1,2])
    Item
    Outcome
    text
    Outcome
    Code List
    Outcome
    CL Item
    Fatal/ Died  (1)
    CL Item
    Intervention for AE Continuing  (2)
    CL Item
    Not Recovered/Not Resolved (3)
    CL Item
    Recovered/Resolved with Sequelae  (4)
    CL Item
    Recovered/Resolved without Sequelae (5)
    CL Item
    Recovering/Resolving (6)
    Consent Form Change Required?
    Item
    Consent Form Change Required?
    boolean
    C0009797 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: Fatal (resulted in death)
    boolean
    C1706737 (UMLS CUI [1,1])
    C1302234 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: A life-threatening occurrence
    boolean
    C1706737 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
    boolean
    C1706737 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: Results in persistent or significant disability/incapacity
    boolean
    C1706737 (UMLS CUI [1,1])
    C0231170 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: Results in congenital anomaly/birth defect
    boolean
    C1706737 (UMLS CUI [1,1])
    C0000768 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
    boolean
    C1706737 (UMLS CUI [1,1])
    C4035998 (UMLS CUI [1,2])
    SAE Classification
    Item
    SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
    boolean
    C1706737 (UMLS CUI [1,1])
    C3845751 (UMLS CUI [1,2])
    C0683675 (UMLS CUI [2])
    C0870486 (UMLS CUI [3])
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