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ID

16630

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

July 27, 2016

DOI

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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

    Protocol or IRB Number
    Description

    Protocol or IRB Number

    Data type

    integer

    Protocol Short Title
    Description

    Protocol Short Title

    Data type

    text

    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Subject ID
    Description

    Subject ID

    Data type

    integer

    Serious Adverse Event
    Description

    Serious Adverse Event

    Event Start Date
    Description

    Event Start Date

    Data type

    date

    Event End Date
    Description

    Event End Date

    Data type

    date

    Date Reported
    Description

    Date Reported

    Data type

    date

    Reported to Research Staff Bv
    Description

    Reported to Research Staff Bv

    Data type

    text

    Death Date (if applicable)
    Description

    Death Date (if applicable)

    Data type

    date

    Death Occurred
    Description

    Death Occurred

    Data type

    text

    Did the SAE occur at your site or at a site for which the PI is responsible?
    Description

    SAE

    Data type

    boolean

    SAE Description/Narrative
    Description

    SAE Description/Narrative

    Data type

    text

    Treating Physician Comments (if applicable)
    Description

    Treating Physician Comments (if applicable)

    Data type

    text

    PI Comments
    Description

    PI Comments

    Data type

    text

    Outcome
    Description

    Outcome

    Data type

    text

    Consent Form Change Required?
    Description

    Consent Form Change Required?

    Data type

    boolean

    SAE Classification: Fatal (resulted in death)
    Description

    SAE Classification

    Data type

    boolean

    SAE Classification: A life-threatening occurrence
    Description

    SAE Classification

    Data type

    boolean

    SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
    Description

    SAE Classification

    Data type

    boolean

    SAE Classification: Results in persistent or significant disability/incapacity
    Description

    SAE Classification

    Data type

    boolean

    SAE Classification: Results in congenital anomaly/birth defect
    Description

    SAE Classification

    Data type

    boolean

    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

    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

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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
    Protocol or IRB Number
    Item
    Protocol or IRB Number
    integer
    Protocol Short Title
    Item
    Protocol Short Title
    text
    Subject Initials
    Item
    Subject Initials
    text
    Subject ID
    Item
    Subject ID
    integer
    Item Group
    Serious Adverse Event
    Event Start Date
    Item
    Event Start Date
    date
    Event End Date
    Item
    Event End Date
    date
    Date Reported
    Item
    Date Reported
    date
    Reported to Research Staff Bv
    Item
    Reported to Research Staff Bv
    text
    Death Date (if applicable)
    Item
    Death Date (if applicable)
    date
    Item
    Death Occurred
    text
    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
    SAE Description/Narrative
    Item
    SAE Description/Narrative
    text
    Treating Physician Comments (if applicable)
    Item
    Treating Physician Comments (if applicable)
    text
    PI Comments
    Item
    PI Comments
    text
    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
    SAE Classification
    Item
    SAE Classification: Fatal (resulted in death)
    boolean
    SAE Classification
    Item
    SAE Classification: A life-threatening occurrence
    boolean
    SAE Classification
    Item
    SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
    boolean
    SAE Classification
    Item
    SAE Classification: Results in persistent or significant disability/incapacity
    boolean
    SAE Classification
    Item
    SAE Classification: Results in congenital anomaly/birth defect
    boolean
    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
    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
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