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ID

36355

Beschrijving

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

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Versies (1)
  1. 06-05-19 06-05-19 -
Houder van rechten

GlaxoSmithKline

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6 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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    The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

    Engels

    Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

    1 Formulieren  
    Pharmacogenetic Research Consent
    Beschrijving

    Pharmacogenetic Research Consent

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

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If informed consent has been obtained, record date informed consent obtained.
    Beschrijving

    If informed consent has been obtained, record date informed consent obtained.

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    If informed consent has been obtained, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record date sample taken.
    Beschrijving

    Date sample taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C1302413
    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
    Beschrijving

    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, please specify.
    Beschrijving

    Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Withdrawal of consent for PGx (DNA) sample destruction
    Beschrijving

    Withdrawal of consent for PGx (DNA) sample destruction

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C1948029
    UMLS CUI-3
    C0178913
    Has subject withdrawn consent for PGx research?
    Beschrijving

    Has subject withdrawn consent for PGx research?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    If subject has withdrawn consent for PGx research, record date informed consent withdrawn
    Beschrijving

    If subject has withdrawn consent for PGx research, record date informed consent withdrawn

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    UMLS CUI [1,3]
    C0011008
    Has a request been made for sample destruction?
    Beschrijving

    Has a request been made for sample destruction?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    If a request has been made for sample destruction check reason
    Beschrijving

    If a request has been made for sample destruction check reason

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    If other reason for request has been made for sample destruction, please specify
    Beschrijving

    If other reason for request has been made for sample destruction, please specify

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    UMLS CUI [1,5]
    C0392360
    UMLS CUI [1,6]
    C0205394
    UMLS CUI [1,7]
    C2348235
    Terug naar het begin van de pagina

    Similar models

    Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Pharmacogenetic 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 informed consent has been obtained, record date informed consent obtained.
    Item
    If informed consent has been obtained, record date informed consent obtained.
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Item
    If informed consent has been obtained, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Date sample taken
    Item
    If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record date sample taken.
    date
    C0031328 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Item
    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
    Code List
    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    Other reason for informed consent has not been obtained for PGx-Pharmacogenetic research
    Item
    If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, please specify.
    text
    C0031325 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item Group
    Withdrawal of consent for PGx (DNA) sample destruction
    C1707492 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C0178913 (UMLS CUI-3)
    Has subject withdrawn consent for PGx research?
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    If subject has withdrawn consent for PGx research, record date informed consent withdrawn
    Item
    If subject has withdrawn consent for PGx research, record date informed consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C0031325 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    If a request has been made for sample destruction check reason
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    If a request has been made for sample destruction check reason
    Code List
    If a request has been made for sample destruction check reason
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (Z)
    If other reason for request has been made for sample destruction, please specify
    Item
    If other reason for request has been made for sample destruction, please specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0392360 (UMLS CUI [1,5])
    C0205394 (UMLS CUI [1,6])
    C2348235 (UMLS CUI [1,7])
    Terug naar het begin van de pagina 

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