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ID

35804

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 25, 2019

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License

Creative Commons BY-NC 3.0
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    Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

    English

    CRF Tracking/Review Form (TRF)

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Investigator
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1320303
    CRF Tracking/Review Form
    Description

    CRF Tracking/Review Form

    Alias
    UMLS CUI-1
    C3889409
    Screening Failure
    Description

    Trial Screening; failed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1710477
    UMLS CUI [1,2]
    C0231175
    Module
    Description

    Module

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709061
    Module Description
    Description

    Module, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709061
    UMLS CUI [1,2]
    C0678257
    Page Range
    Description

    Case Report Form, Page

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C1704732
    Modules
    Description

    Module, Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709061
    UMLS CUI [1,2]
    C0449438
    Missing pages (if applicable)
    Description

    Case Report Form, Page, Missing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C1704732
    UMLS CUI [1,3]
    C1705492
    Site Monitor’s comments (eg. protocol violations or deviations)
    Description

    Case Report Form, Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C0947611
    Signature
    Description

    Signature

    Alias
    UMLS CUI-1
    C1519316
    Site Monitor’s Name
    Description

    Medical Monitor, Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1708968
    UMLS CUI [1,2]
    C0027365
    Site Monitor’s Signature
    Description

    Medical Monitor, Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1708968
    UMLS CUI [1,2]
    C1519316
    Date Submitted
    Description

    Case Report Form, Submission, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C1515022
    UMLS CUI [1,3]
    C0011008
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    Similar models

    CRF Tracking/Review Form (TRF)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Centre Number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator
    text
    C1320303 (UMLS CUI [1])
    Item Group
    CRF Tracking/Review Form
    C3889409 (UMLS CUI-1)
    Trial Screening; failed
    Item
    Screening Failure
    boolean
    C1710477 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Item
    Module
    text
    C1709061 (UMLS CUI [1])
    Module
    Code List
    Module
    CL Item
    MOD1  (1)
    CL Item
    MOD2  (2)
    CL Item
    MOD3  (3)
    CL Item
    MOD4  (4)
    CL Item
    MOD5  (5)
    CL Item
    SAE1&2  (6)
    CL Item
    FORMD1 (7)
    Item
    Module Description
    text
    C1709061 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Module, Description
    Code List
    Module Description
    CL Item
    Screening to Study Conc.  (1)
    CL Item
    RLS Rating Scales (2)
    CL Item
    Patient Scales (3)
    CL Item
    WPAI Wks 9 - 12 (4)
    CL Item
    Evening Vst Orthostatic Vitals  (5)
    CL Item
    Serious Adverse Experiences  (6)
    CL Item
    Form D (7)
    Item
    Page Range
    text
    C1516308 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    Case Report Form, Page
    Code List
    Page Range
    CL Item
    1-72  (1)
    CL Item
    79 - 117  (2)
    CL Item
    118 - 181  (3)
    CL Item
    182 - 189 (4)
    CL Item
    190 - 197  (5)
    CL Item
    73 - 76  (6)
    CL Item
    77 (7)
    Item
    Modules
    text
    C1709061 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Case Report Form, Page
    Code List
    Modules
    CL Item
    Sent to DM (1)
    CL Item
    Unused  (2)
    Case Report Form, Page, Missing
    Item
    Missing pages (if applicable)
    text
    C1516308 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    C1705492 (UMLS CUI [1,3])
    Case Report Form, Comment
    Item
    Site Monitor’s comments (eg. protocol violations or deviations)
    text
    C1516308 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Signature
    C1519316 (UMLS CUI-1)
    Medical Monitor, Name
    Item
    Site Monitor’s Name
    text
    C1708968 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Medical Monitor, Signature
    Item
    Site Monitor’s Signature
    text
    C1708968 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Case Report Form, Submission, Date in time
    Item
    Date Submitted
    date
    C1516308 (UMLS CUI [1,1])
    C1515022 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
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