0 Evaluaciones
ID

34036

Descripción

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Palabras clave

Versiones (2)
  1. 9/11/18 9/11/18 -
  2. 11/1/19 11/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

11 de enero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

    Inglés

    Pharmacogenetics Research Consent Form

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Descripción

    Site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Descripción

    Patient

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Date of Visit/Assessment
    Descripción

    Date of Visit/Assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Date of Visit/Assessment
    Descripción

    Date of Visit/Assessment

    Date
    Descripción

    Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    PGx Research Consent
    Descripción

    PGx Research Consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C2347500
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Descripción

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If YES, record date informed consent obtained for PGx-Pharmacogenetic research
    Descripción

    If YES, record date informed consent obtained for PGx-Pharmacogenetic research

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
    Descripción

    Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031325
    If YES, record date sample taken
    Descripción

    If YES, record date sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0031325
    If NO informed consent obtained, check reason
    Descripción

    If NO informed consent obtained, check reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C1882120
    If Other, specify
    Descripción

    If Other, specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Genetics Type
    Descripción

    Genetics Type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0017399
    UMLS CUI [1,2]
    C0332307
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    Similar models

    Pharmacogenetics Research Consent Form

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C1299487 (UMLS CUI [1])
    Patient Number
    Item
    Patient Number
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Date of Visit/Assessment
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Date of Visit/Assessment
    Date
    Item
    Date
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    PGx Research Consent
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    If YES, record date informed consent obtained for PGx-Pharmacogenetic research
    Item
    If YES, record date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
    Item
    Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
    boolean
    C0005834 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    If YES, record date sample taken
    Item
    If YES, record date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    Item
    If NO informed consent obtained, check reason
    text
    C0392360 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1882120 (UMLS CUI [1,3])
    If NO informed consent obtained, check reason
    Code List
    If NO informed consent obtained, check reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other (3)
    If Other, specify
    Item
    If Other, specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Genetics Type
    Item
    Genetics Type
    text
    C0017399 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
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