0 Beoordelingen
ID

18749

Beschrijving

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

Trefwoorden

Versies (2)
  1. 27-07-16 27-07-16 -
  2. 18-11-16 18-11-16 -
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18 november 2016

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

    Engels

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 Formulieren  
    Header
    Beschrijving

    Header

    PI Name
    Beschrijving

    PI Name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    UMLS CUI [1,2]
    C1521895 (Principal Investigator)
    SNOMED
    768818001
    Protocol or IRB Number
    Beschrijving

    Protocol or IRB Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348563 (Study Protocol)
    Protocol Short Title
    Beschrijving

    Protocol Short Title

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C1705824 (Trial Title)
    Subject Initials
    Beschrijving

    Subject Initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Subject ID
    Beschrijving

    Subject ID

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Serious Adverse Event
    Beschrijving

    Serious Adverse Event

    Event Start Date
    Beschrijving

    Event Start Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2697888 (Adverse Event Start Date)
    Event End Date
    Beschrijving

    Event End Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2697886 (Adverse Event End Date)
    Date Reported
    Beschrijving

    Date Reported

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0700287 (Reporting)
    SNOMED
    223458004
    Reported to Research Staff Bv
    Beschrijving

    Reported to Research Staff Bv

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0700287 (Reporting)
    SNOMED
    223458004
    UMLS CUI [1,2]
    C2986262 (Research Staff Job Title)
    Death Date (if applicable)
    Beschrijving

    Death Date (if applicable)

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    Death Occurred
    Beschrijving

    Death Occurred

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1306577 (Death (finding))
    LOINC
    LA7424-0
    UMLS CUI [1,2]
    C2745955 (Occurrence)
    SNOMED
    246454002
    Did the SAE occur at your site or at a site for which the PI is responsible?
    Beschrijving

    SAE

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0678341 (Responsibility)
    SAE Description/Narrative
    Beschrijving

    SAE Description/Narrative

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    Treating Physician Comments (if applicable)
    Beschrijving

    Treating Physician Comments (if applicable)

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C1710470 (Treating Physician)
    PI Comments
    Beschrijving

    PI Comments

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C1521895 (Principal Investigator)
    SNOMED
    768818001
    Outcome
    Beschrijving

    Outcome

    Datatype

    text

    Consent Form Change Required?
    Beschrijving

    Consent Form Change Required?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009797 (Consent Forms)
    UMLS CUI [1,2]
    C0392747 (Changing)
    SNOMED
    18307000
    SAE Classification: Fatal (resulted in death)
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C1302234 (Fatal)
    SNOMED
    399166001
    SAE Classification: A life-threatening occurrence
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C2826244 (Life Threatening)
    SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    SAE Classification: Results in persistent or significant disability/incapacity
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C0231170 (Disability)
    SNOMED
    21134002
    LOINC
    MTHU064635
    SAE Classification: Results in congenital anomaly/birth defect
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C0000768 (Congenital Abnormality)
    SNOMED
    276654001
    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.
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C4035998 (Surgical/procedural intervention)
    LOINC
    LA21145-0
    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.
    Beschrijving

    SAE Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1706737 (Adverse Event Classification)
    UMLS CUI [1,2]
    C3845751 (Confidentiality breach)
    LOINC
    LA7407-5
    UMLS CUI [2]
    C0683675 (civil liability)
    UMLS CUI [3]
    C0870486 (Employability)
    Terug naar het begin van de pagina

    Similar models

    Serious Adverse Event Part I: CRF Wisconsin Madison

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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