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38259

Beschreibung

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Pharmacogenetic research consent and withdrawal of consent form.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Stichworte

Versionen (2)
  1. 05.10.19 05.10.19 -
  2. 11.10.19 11.10.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

    Englisch

    Pharmacogenetic research consent and withdrawal of consent

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    PGx - Pharmacogenetic research consent
    Beschreibung

    PGx - Pharmacogenetic research consent

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

    If you tick Yes, please fill in the Date informed consent obtained for PGx-Pharmacogenetic research and if a blood sample has been collected in the following items. If you tick No, please check the reason in the item "No informed consent obtained for PGx, reason".

    Datentyp

    text

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

    day month year

    Datentyp

    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?
    Beschreibung

    If you tick Yes, please record the date sample taken in the following item.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    No informed consent obtained for PGx, reason
    Beschreibung

    No informed consent obtained for PGx, reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C1298908
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C2347500
    If other reason for no informed consent obtaining, please specify
    Beschreibung

    Other reason for no informed consent obtaining

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C2347500
    UMLS CUI [1,5]
    C1882120
    Date of sample taken of PGx
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C2347500
    Pharmacogenetic research withdrawal of consent
    Beschreibung

    Pharmacogenetic research withdrawal of consent

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C2347500
    Has subject withdrawn consent for PGx research?
    Beschreibung

    If you tick Yes, please note the date of informed consent withdrawn in the following item.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    Date of informed consent withdrawn
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has a request been made for sample destruction?
    Beschreibung

    If you tick Yes, please check reason in the following item.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    Reason for request for sample destruction
    Beschreibung

    Reason for request for sample destruction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C1272683
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C0178913
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Pharmacogenetic research consent and withdrawal of consent

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    PGx - Pharmacogenetic research consent
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Informed consent for PGx
    Code List
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date informed consent obtained for PGx-Pharmacogenetic research
    Item
    Date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    text
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Blood sample for PGx
    Code List
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    No informed consent obtained for PGx, reason
    text
    C0566251 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    No informed consent obtained for PGx, reason
    Code List
    No informed consent obtained for PGx, reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other (Z)
    Other reason for no informed consent obtaining
    Item
    If other reason for no informed consent obtaining, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    C1882120 (UMLS CUI [1,5])
    Date of sample taken of PGx
    Item
    Date of sample taken of PGx
    date
    C1302413 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Item Group
    Pharmacogenetic research withdrawal of consent
    C1707492 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has subject withdrawn consent for PGx research?
    text
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Withdrawn consent for PGx
    Code List
    Has subject withdrawn consent for PGx research?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Date of informed consent withdrawn
    Item
    Date of informed consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Has a request been made for sample destruction?
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Request for sample destruction
    Code List
    Has a request been made for sample destruction?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Reason for request for sample destruction
    text
    C0566251 (UMLS CUI [1,1])
    C1272683 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C0178913 (UMLS CUI [1,4])
    Reason for request for sample destruction
    Code List
    Reason for request for sample destruction
    CL Item
    Subject withdrew consent for PGx (1)
    CL Item
    Screen failure (2)
    CL Item
    Other (Z)
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