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ID

38752

Description

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

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Versions (1)
  1. 10/31/19 10/31/19 -
Copyright Holder

GlaxoSmithKline

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October 31, 2019

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Creative Commons BY-NC 3.0
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    Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

    English

    Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

    1 forms  
    Pharmacogenetic Research Consent
    Description

    Pharmacogenetic Research Consent

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

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    Date informed consent obtained for GPx-Pharmacogenetic research
    Description

    Date informed consent obtained for GPx-Pharmacogenetic research

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    If no informed consent obtained for Pharmacogenetic research, check reason
    Description

    If no informed consent obtained for Pharmacogenetic research, check reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0392360
    If other reason for informed consent not been obtained, specify
    Description

    If other reason for informed consent not been obtained, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [1,5]
    C2348235
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    If a blood sample has been taken, record date sample taken
    Description

    If a blood sample has been taken, record date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    Pharmacogenetic Research Withdrawal of Consent
    Description

    Pharmacogenetic Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C0031325
    Has subject withdrawn consent for PGx research?
    Description

    Has subject withdrawn consent for PGx research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0031325
    Date informed consent withdrawn
    Description

    Date informed consent withdrawn

    Data type

    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?
    Description

    Has a request been made for sample destruction?

    Data type

    boolean

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

    If request for sample destruction has been made, check reason

    Data type

    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 for sample destruction, specify
    Description

    If other reason for request for sample destruction, specify

    Data type

    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]
    C0205394
    UMLS CUI [1,6]
    C2348235
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    Similar models

    Pharmacogenetic Research Consent; Pharmacogenetic Research Withdrawal of Consent

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Date informed consent obtained for GPx-Pharmacogenetic research
    Item
    Date informed consent obtained for GPx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If no informed consent obtained for Pharmacogenetic research, check reason
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    If no informed consent obtained for Pharmacogenetic research, check reason
    Code List
    If no informed consent obtained for Pharmacogenetic research, check reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    If other reason for informed consent not been obtained, specify
    Item
    If other reason for informed consent not been obtained, specify
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    If a blood sample has been taken, record date sample taken
    Item
    If a blood sample has been taken, record date sample taken
    date
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Pharmacogenetic Research Withdrawal of Consent
    C1707492 (UMLS CUI-1)
    C0031325 (UMLS CUI-2)
    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])
    Date informed consent withdrawn
    Item
    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 request for sample destruction has been made, check reason
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    If request for sample destruction has been made, check reason
    Code List
    If request for sample destruction has been made, 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 for sample destruction, specify
    Item
    If other reason for request for sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    C2348235 (UMLS CUI [1,6])
    Back to the top of the page 

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