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ID

30792

Beschrijving

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

Trefwoorden

  1. 30-07-16 30-07-16 -
  2. 25-11-16 25-11-16 -
  3. 20-06-18 20-06-18 - Julian Varghese
Houder van rechten

Wisconsin Madison

Geüploaded op

20 juni 2018

DOI

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Licentie

Creative Commons BY 3.0

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    Subject Off Study: CRF Wisconsin Madison

    Subject Off Study: CRF Wisconsin Madison

    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
    IRB Number
    Beschrijving

    IRB Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0086911 (Ethics Committees, Research)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    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)
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Subject Off Study
    Beschrijving

    Subject Off Study

    Date subject went Off Study
    Beschrijving

    Off Study Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985813 (Off Study Date)
    Last visit completed
    Beschrijving

    Last visit

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C1517741 (Last)
    LOINC
    LP200101-6
    UMLS CUI [1,3]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    Indicate the primary reason the subject is no longer participating in the study
    Beschrijving

    Primary reason

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1549995 (Primary Reason)
    UMLS CUI [1,2]
    C2348570 (Study Terminated)
    Was subject treatment unblinded?
    Beschrijving

    Was subject treatment unblinded?

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826259 (Subject Unblinding)
    Additional explanation required:
    Beschrijving

    Additional explanation required

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0681841 (Explanation)
    LOINC
    LA15331-4
    UMLS CUI [1,2]
    C1524062 (Additional)
    LOINC
    LP35025-3
    Form completed by
    Beschrijving

    Form completed by

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1550483 (data entry person)

    Similar models

    Subject Off Study: CRF Wisconsin Madison

    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])
    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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