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ID

30792

Descrição

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Off Study. 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

Palavras-chave

  1. 30/07/2016 30/07/2016 -
  2. 25/11/2016 25/11/2016 -
  3. 20/06/2018 20/06/2018 - Julian Varghese
Titular dos direitos

Wisconsin Madison

Transferido a

20 de junho de 2018

DOI

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Licença

Creative Commons BY 3.0

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    Subject Off Study: CRF Wisconsin Madison

    Subject Off Study: CRF Wisconsin Madison

    Header
    Descrição

    Header

    PI Name
    Descrição

    PI Name

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1521895
    IRB Number
    Descrição

    IRB Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0086911
    UMLS CUI [1,2]
    C0237753
    Short Title
    Descrição

    Protocol Short Title

    Tipo de dados

    text

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

    Subject Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440
    Subject ID
    Descrição

    Subject ID

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date
    Descrição

    Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Subject Off Study
    Descrição

    Subject Off Study

    Date subject went Off Study
    Descrição

    Off Study Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2985813
    Last visit completed
    Descrição

    Last visit

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0205197
    Indicate the primary reason the subject is no longer participating in the study
    Descrição

    Primary reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1549995
    UMLS CUI [1,2]
    C2348570
    Was subject treatment unblinded?
    Descrição

    Was subject treatment unblinded?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826259
    Additional explanation required:
    Descrição

    Additional explanation required

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0681841
    UMLS CUI [1,2]
    C1524062
    Form completed by
    Descrição

    Form completed by

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1550483

    Similar models

    Subject Off Study: CRF Wisconsin Madison

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    PI Name
    Item
    PI Name
    text
    C0027365 (UMLS CUI [1,1])
    C1521895 (UMLS CUI [1,2])
    IRB Number
    Item
    IRB Number
    integer
    C0086911 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Protocol Short Title
    Item
    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])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Subject Off Study
    Off Study Date
    Item
    Date subject went Off Study
    date
    C2985813 (UMLS CUI [1])
    Item
    Last visit completed
    text
    C0545082 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Code List
    Last visit completed
    CL Item
    Screening visit (1)
    CL Item
    Visit 1 (2)
    CL Item
    Visit 2 (3)
    Item
    Indicate the primary reason the subject is no longer participating in the study
    text
    C1549995 (UMLS CUI [1,1])
    C2348570 (UMLS CUI [1,2])
    Code List
    Indicate the primary reason the subject is no longer participating in the study
    CL Item
    Study Activities Completed (1)
    CL Item
    Subject Withdrawn (by subject) PRIOR to enrollment (i.e. subject deemed eligible but declined participation, etc.) Additional explanation required.  (2)
    CL Item
    Subject Withdrawn (by subject) AFTER enrollment (i.e. due to personal time constraints, etc.) Additional explanation required.  (3)
    CL Item
    Subject Withdrawn (by PI or study team) PRIOR to enrollment (i.e. subject deemed inappropriate for study participation by the PI or study team, explain below) (4)
    CL Item
    Subject Withdrawn (by PI or study team) AFTER enrollment (i.e. identification of disease/condition after enrollment that warrants withdrawal, participant was determined to be ineligible after enrollment etc.) (5)
    CL Item
    Adverse Events/Side effects/Complications (complete Adverse Tracking Log) Additional explanation required.  (6)
    CL Item
    Other. Additional explanation required. (7)
    Item
    Was subject treatment unblinded?
    text
    C2826259 (UMLS CUI [1])
    Code List
    Was subject treatment unblinded?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not Applicable (3)
    Additional explanation required
    Item
    Additional explanation required:
    text
    C0681841 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
    Form completed by
    Item
    Form completed by
    text
    C1550483 (UMLS CUI [1])

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