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ID

36355

Description

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

Mots-clés

Versions (1)
  1. 06/05/2019 06/05/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

6 mai 2019

DOI

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Licence

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

    Anglais

    Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

    1 Formulaires  
    Pharmacogenetic Research Consent
    Description

    Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C0021430 (Informed Consent)
    UMLS CUI-2
    C2347500 (Pharmacogenetic Test)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If informed consent has been obtained, record date informed consent obtained.
    Description

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

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    If informed consent has been obtained, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    If a blood sample has been collected for PGx-pharmacogenetic (DNA) research, record date sample taken.
    Description

    Date sample taken

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason.
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason for informed consent has not been obtained for PGx-Pharmacogenetic research, please specify.
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,4]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,5]
    C2348235 (Specification)
    Withdrawal of consent for PGx (DNA) sample destruction
    Description

    Withdrawal of consent for PGx (DNA) sample destruction

    Alias
    UMLS CUI-1
    C1707492 (Consent Withdrawn)
    UMLS CUI-2
    C1948029 (Destruction (action))
    UMLS CUI-3
    C0178913 (Blood specimen)
    SNOMED
    119297000
    Has subject withdrawn consent for PGx research?
    Description

    Has subject withdrawn consent for PGx research?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C0031325 (Pharmacogenetics)
    If subject has withdrawn consent for PGx research, record date informed consent withdrawn
    Description

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

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C0031325 (Pharmacogenetics)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Has a request been made for sample destruction?
    Description

    Has a request been made for sample destruction?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    If a request has been made for sample destruction check reason
    Description

    If a request has been made for sample destruction check reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,4]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If other reason for request has been made for sample destruction, please specify
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,4]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,5]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,6]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,7]
    C2348235 (Specification)
    Retour au début de la page

    Similar models

    Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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