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22593

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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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  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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    SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    SUBJECT ELIGIBILITY (SCREENING) 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
    SUBJECT ELIGIBILITY
    Description

    SUBJECT ELIGIBILITY

    Date Subject Signed Protocol Informed Consent:
    Description

    INFORM_CONSENT_DT

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782 (Informed Consent Date)
    Did subject meet all eligibility criteria?
    Description

    If No: • Indicate the line number(s) (from worksheet) of eligibility criteria that was not met • Provide details of the deviation from the specified eligibility criteria • Indicate if waiver was given and the date granted

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1302261 (Patient eligible for clinical trial)
    SNOMED
    399223003
    Eligibility Criteria Not Met
    Description

    Eligibility Criteria Not Met

    Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
    Description

    CRIT_NOTMET

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516637 (Clinical Trial Eligibility Criteria)
    Details
    Description

    DEVIATION_DETAILS

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1555471 (Not Eligible)
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Was A Waiver Granted?
    Description

    APPROVAL

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707901 (Eligibility Waiver)
    If Yes, Date:
    Description

    APPROVAL_DT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1707901 (Eligibility Waiver)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    SUBJECT ELIGIBILITY (SCREENING) 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
    SUBJECT ELIGIBILITY
    INFORM_CONSENT_DT
    Item
    Date Subject Signed Protocol Informed Consent:
    date
    C2985782 (UMLS CUI [1])
    Item
    Did subject meet all eligibility criteria?
    integer
    C1302261 (UMLS CUI [1])
    HAND_MOVEMENT_DESC [HDMVTD]
    Code List
    Did subject meet all eligibility criteria?
    CL Item
    With Direction (1)
    CL Item
    Without Direction (2)
    Item Group
    Eligibility Criteria Not Met
    CRIT_NOTMET
    Item
    Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
    text
    C1516637 (UMLS CUI [1,1])
    DEVIATION_DETAILS
    Item
    Details
    text
    C1555471 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    APPROVAL
    Item
    Was A Waiver Granted?
    boolean
    C1707901 (UMLS CUI [1,1])
    APPROVAL_DT
    Item
    If Yes, Date:
    date
    C1707901 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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