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ID

22588

Description

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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Versions (1)
  1. 6/8/17 6/8/17 -
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Genentech, Inc.

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June 8, 2017

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Creative Commons BY-NC 3.0
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    INVESTIGATOR / SITE CHANGE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    INVESTIGATOR / SITE CHANGE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Initials:
    Description

    PTINIT

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1997894 (Clinical trial participant (person))
    SNOMED
    428024001
    UMLS CUI [1,2]
    C2986440 (Person Initials)
    Report Date:
    Description

    VDT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302584 (Date of report)
    SNOMED
    399651003
    Study administration
    Description

    Study administration

    Investigator Number
    Description

    INV_NUMBER

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826689 (Investigator Identifier)
    Site Number
    Description

    SITE_NUMBER

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018704 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Effective Date of Change:
    Description

    Effective Date of Change: The date of subject’s first contact with the new investigator/site.

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C1302393 (Date of admission)
    SNOMED
    399423000
    DD/MMM/YY
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    Similar models

    INVESTIGATOR / SITE CHANGE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient administration
    PT
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    PTINIT
    Item
    Subject Initials:
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    VDT
    Item
    Report Date:
    date
    C1302584 (UMLS CUI [1,1])
    Item Group
    Study administration
    INV_NUMBER
    Item
    Investigator Number
    integer
    C2826689 (UMLS CUI [1])
    SITE_NUMBER
    Item
    Site Number
    text
    C0018704 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    INV_CHANGE_DT [INVDT]
    Item
    Effective Date of Change:
    date
    C1302393 (UMLS CUI [1])
    Back to the top of the page 

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