0 Beoordelingen
ID

36087

Beschrijving

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 (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the Drug Screening and Alcohol Breath Test for screening form. It has to be filled in for screening.

Trefwoorden

Versies (2)
  1. 15-04-19 15-04-19 -
  2. 15-04-19 15-04-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 april 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole, 101468/201

    Engels

    Drug Screening and Alcohol Breath Test for screening

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beschrijving

    Subject No.:

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beschrijving

    Panel ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Drug Screening
    Beschrijving

    Drug Screening

    Alias
    UMLS CUI-1
    C0373483
    Exact date of urine sampling
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    Exact time of urine sampling
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0040223
    Were there any contra-indicated drugs detected?
    Beschrijving

    If YES, please record all the relevant contra-indicated drugs below.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C1444657
    UMLS CUI [1,3]
    C1254351
    Type of drug
    Beschrijving

    Type of drug

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Beschrijving

    Comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    Alcohol breath test
    Beschrijving

    Alcohol breath test

    Alias
    UMLS CUI-1
    C0202306
    Exact date of test
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0011008
    Exact time of test
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0429928
    Result of Alcohol breath test
    Beschrijving

    Alcohol breath test result, tick one If POSITIVE, do not include the subject in the study.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1274040
    Terug naar het begin van de pagina

    Similar models

    Drug Screening and Alcohol Breath Test for screening

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Drug Screening
    C0373483 (UMLS CUI-1)
    Urine sampling date
    Item
    Exact date of urine sampling
    date
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Urine sampling time
    Item
    Exact time of urine sampling
    time
    C0042014 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Were there any contra-indicated drugs detected?
    text
    C1511790 (UMLS CUI [1,1])
    C1444657 (UMLS CUI [1,2])
    C1254351 (UMLS CUI [1,3])
    Contra-indicated drugs detected
    Code List
    Were there any contra-indicated drugs detected?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Type of drug
    Item
    Type of drug
    text
    C0457591 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Alcohol breath test
    C0202306 (UMLS CUI-1)
    Date of test
    Item
    Exact date of test
    date
    C0202306 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of test
    Item
    Exact time of test
    time
    C0202306 (UMLS CUI [1,1])
    C0429928 (UMLS CUI [1,2])
    Item
    Result of Alcohol breath test
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of Alcohol breath test
    Code List
    Result of Alcohol breath test
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial