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ID

36093

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the pregnancy test form. It has to be filled in for all sessions each for day 1 and for follow-up.

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Versions (1)
  1. 15/04/19 15/04/19 -
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GlaxoSmithKline

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15 aprile 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    English

    Pregnancy Test

    1 forms  
    1. StudyEvent: ODM
      1. Pregnancy Test
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test carried out?
    Description

    Pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1272682
    If no pregnancy test, please specify reason
    Description

    No pregnancy test, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C3841220
    UMLS CUI [1,3]
    C0032976
    If pregnancy test, please note Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    If pregnancy test, please note Time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0040223
    Pregnancy test Result
    Description

    If 'Positive', DO NOT include the subject in the study.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0427777
    Test type
    Description

    Please mark box for test type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0332307
    If Other test type, please specify
    Description

    Other pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0032976
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    Similar models

    Pregnancy Test

    1 forms
    1. StudyEvent: ODM
      1. Pregnancy Test
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Session 1 day 1 (1)
    CL Item
    Session 2 day 1  (2)
    CL Item
    Session 3 day 1 (3)
    CL Item
    Session 4 day 1 (4)
    CL Item
    Session 5 day 1 (5)
    CL Item
    Follow-up (6)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Item
    Was a pregnancy test carried out?
    text
    C0032976 (UMLS CUI [1,1])
    C1272682 (UMLS CUI [1,2])
    Pregnancy test
    Code List
    Was a pregnancy test carried out?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    No pregnancy test, reason
    Item
    If no pregnancy test, please specify reason
    text
    C0566251 (UMLS CUI [1,1])
    C3841220 (UMLS CUI [1,2])
    C0032976 (UMLS CUI [1,3])
    Date of pregnancy test
    Item
    If pregnancy test, please note Date of test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of pregnancy test
    Item
    If pregnancy test, please note Time of test
    time
    C0032976 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Pregnancy test Result
    text
    C0427777 (UMLS CUI [1])
    Pregnancy test Result
    Code List
    Pregnancy test Result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item
    Test type
    integer
    C0032976 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Test type
    Code List
    Test type
    CL Item
    Dipstick urine HCG (1)
    CL Item
    Serum HCG (2)
    CL Item
    Other (3)
    Other pregnancy test
    Item
    If Other test type, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
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