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ID

36907

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pre-dose Drug screen, Pre-dose pregnancy test and the pre-dose alcohol test form. It has to be filled in at Day 1.

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Versions (2)
  1. 9/1/17 9/1/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 2019

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Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    English

    Pre- Dose Drug Screening, Pregnancy test, Alcohol test

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Pre-dose Drug Screening (Urine)
    Description

    Pre-dose Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274 (Urine drug screen)
    Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247 (Test Date)
    Time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0429928 (Test time)
    SNOMED
    252127002
    Were there any contra-indicated drugs detected?
    Description

    If you tick ‘Yes’, please record all the relevant contra-indicated drugs below. If positive please withdraw the subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    If there are contraindicateddrugs, please specify type of Drug
    Description

    Type of Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457591 (Type of drug)
    SNOMED
    229753003
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Pre-dose Alcohol test
    Description

    Pre-dose Alcohol test

    Alias
    UMLS CUI-1
    C0202304 (Ethanol measurement)
    SNOMED
    430837008
    Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247 (Test Date)
    Time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0429928 (Test time)
    SNOMED
    252127002
    Alcohol test finding
    Description

    If positive please withdraw the subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0495718 (Finding of alcohol in blood)
    SNOMED
    274776000
    Pre-dose Pregnancy test
    Description

    Pre-dose Pregnancy test

    Alias
    UMLS CUI-1
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Was a pregnancy test carried out?
    Description

    Test performance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518965 (Performance Status)
    UMLS CUI [1,2]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    If test was not performed, please specify reason
    Description

    Test not performed, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C3841220 (Test not performed)
    LOINC
    LA13546-9
    UMLS CUI [1,3]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    If test wasperformed, please specify Date of test
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826247 (Test Date)
    If test wasperformed, please specify Time of test
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0429928 (Test time)
    SNOMED
    252127002
    Test result
    Description

    If ‘Positive’, withdraw subject from the study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0427777 (Pregnancy test finding)
    SNOMED
    250421003
    Test type
    Description

    Pregnancy test type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    If other test type, pease specify
    Description

    Other Pregnancy test type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,3]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Laboratory name, if applicable
    Description

    Ensure result is included on laboratory report

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037 (Performing laboratory name)
    LOINC
    LP135668-4
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    Similar models

    Pre- Dose Drug Screening, Pregnancy test, Alcohol test

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Pre-dose Drug Screening (Urine)
    C0202274 (UMLS CUI-1)
    Date of test
    Item
    Date of test
    date
    C2826247 (UMLS CUI [1])
    Time of test
    Item
    Time of test
    time
    C0429928 (UMLS CUI [1])
    Item
    Were there any contra-indicated drugs detected?
    text
    C1301624 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Contraindication drugs
    Code List
    Were there any contra-indicated drugs detected?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Type of Drug
    Item
    If there are contraindicateddrugs, please specify type of Drug
    text
    C0457591 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pre-dose Alcohol test
    C0202304 (UMLS CUI-1)
    Date of test
    Item
    Date of test
    date
    C2826247 (UMLS CUI [1])
    Time of test
    Item
    Time of test
    time
    C0429928 (UMLS CUI [1])
    Item
    Alcohol test finding
    text
    C0495718 (UMLS CUI [1])
    Alcohol test finding
    Code List
    Alcohol test finding
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item Group
    Pre-dose Pregnancy test
    C0032976 (UMLS CUI-1)
    Item
    Was a pregnancy test carried out?
    text
    C1518965 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Test performance
    Code List
    Was a pregnancy test carried out?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If test was not performed, please specify reason
    text
    C0566251 (UMLS CUI [1,1])
    C3841220 (UMLS CUI [1,2])
    C0032976 (UMLS CUI [1,3])
    Test performance
    Code List
    If test was not performed, please specify reason
    Date of test
    Item
    If test wasperformed, please specify Date of test
    date
    C2826247 (UMLS CUI [1])
    Time of test
    Item
    If test wasperformed, please specify Time of test
    time
    C0429928 (UMLS CUI [1])
    Item
    Test result
    text
    C0427777 (UMLS CUI [1])
    Test result
    Code List
    Test result
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item
    Test type
    integer
    C0032976 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Pregnancy test type
    Code List
    Test type
    CL Item
    Dipstick urine HCG (1)
    CL Item
    Serum HCG (2)
    CL Item
    Other (3)
    Other Pregnancy test type
    Item
    If other test type, pease specify
    text
    C0205394 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Laboratory name
    Item
    Laboratory name, if applicable
    text
    C3258037 (UMLS CUI [1])
    Back to the top of the page 

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