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ID

11546

Description

CALGB Adverse Event (AE) Addendum Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4E4F280B-B2A9-266F-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4E4F280B-B2A9-266F-E044-0003BA3F9857

Mots-clés

  1. 20/09/2012 20/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 08/07/2015 08/07/2015 -
Téléchargé le

8 juillet 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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    CALGB Adverse Event (AE) Addendum Form

    If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

    Header
    Description

    Header

    CALGB Form (C-1595)
    Description

    Form ID CALGB

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3262252
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25442
    CALGB Study No.
    Description

    Protocol ID CALGB

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CALGB Patient ID
    Description

    Trial subject ID CALGB

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CTC adverse event report begin date (MM DD YYYY)
    Description

    Adverse Event Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC adverse event report end date (MM DD YYYY)
    Description

    Adverse Event End Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697886
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass
    C49704
    Are data amended
    Description

    Data amended

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Patient demographics
    Description

    Patient demographics

    Patient Initials (Last, First Middle)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No.
    Description

    Medical Record Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Institution/Affiliate
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group
    Description

    Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Description

    Study Number Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Additional Form
    Description

    Additional Form

    Page
    Description

    Additional Form Page Number

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1706499
    NCI Thesaurus ObjectClass-2
    C25406
    UMLS CUI-2
    C1704732
    NCI Thesaurus Property
    C25695
    UMLS CUI-3
    C0237753
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ValueDomain-2
    C42783
    Page
    Description

    Additional Form Page Number

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1706499
    NCI Thesaurus ObjectClass-2
    C25406
    UMLS CUI-2
    C1704732
    NCI Thesaurus Property
    C25695
    UMLS CUI-3
    C0237753
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus ValueDomain-2
    C42783
    Expected Adverse Events
    Description

    Expected Adverse Events

    MedDRA Code (Use NCI CTCAE version specified on study-specific AE form)
    Description

    MedDRACode

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC adverse event term
    Description

    CTC Adverse Event Term

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE grade (^2)
    Description

    CTC Adverse Event Grade

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code (^2)
    Description

    CTC Adverse Event Attribution Category

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Completed by (Last name, First name)
    Description

    Person Completing Form

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed
    Description

    Date Form Completed

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367

    Similar models

    If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form (C-1595)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3262252 (UMLS CUI-1)
    C19464 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus ObjectClass-2)
    Protocol ID CALGB
    Item
    CALGB Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Adverse Event Start Date
    Item
    CTC adverse event report begin date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Adverse Event End Date
    Item
    CTC adverse event report end date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697886 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Patient demographics
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Participating Group
    Item
    Participating Group
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Additional Form
    Additional Form Page Number
    Item
    Page
    text
    C19464 (NCI Thesaurus ObjectClass)
    C1706499 (UMLS CUI-1)
    C25406 (NCI Thesaurus ObjectClass-2)
    C1704732 (UMLS CUI-2)
    C25695 (NCI Thesaurus Property)
    C0237753 (UMLS CUI-3)
    C25337 (NCI Thesaurus ValueDomain)
    C42783 (NCI Thesaurus ValueDomain-2)
    Additional Form Page Number
    Item
    Page
    text
    C19464 (NCI Thesaurus ObjectClass)
    C1706499 (UMLS CUI-1)
    C25406 (NCI Thesaurus ObjectClass-2)
    C1704732 (UMLS CUI-2)
    C25695 (NCI Thesaurus Property)
    C0237753 (UMLS CUI-3)
    C25337 (NCI Thesaurus ValueDomain)
    C42783 (NCI Thesaurus ValueDomain-2)
    Item Group
    Expected Adverse Events
    MedDRACode
    Item
    MedDRA Code (Use NCI CTCAE version specified on study-specific AE form)
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CTC Adverse Event Term
    Item
    CTC adverse event term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE grade (^2)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code (^2)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code (^2)
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possible (possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (definite)
    CL209464 (NCI Metathesaurus)
    Person Completing Form
    Item
    Completed by (Last name, First name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)

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