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ID

38259

Description

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.

Lien

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

Mots-clés

Versions (2)
  1. 05/10/19 05/10/19 -
  2. 11/10/19 11/10/19 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

5 ottobre 2019

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Pharmacogenetic research consent and withdrawal of consent

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    PGx - Pharmacogenetic research consent
    Description

    PGx - 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

    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".

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    Date informed consent obtained for PGx-Pharmacogenetic research
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    No informed consent obtained for PGx, reason
    Description

    No informed consent obtained for PGx, reason

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C1298908 (no)
    SNOMED
    373067005
    UMLS CUI [1,3]
    C0021430 (Informed Consent)
    UMLS CUI [1,4]
    C2347500 (Pharmacogenetic Test)
    If other reason for no informed consent obtaining, please specify
    Description

    Other reason for no informed consent obtaining

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C0021430 (Informed Consent)
    UMLS CUI [1,4]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,5]
    C1882120 (Not Obtained)
    Date of sample taken of PGx
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    Pharmacogenetic research withdrawal of consent
    Description

    Pharmacogenetic research withdrawal of consent

    Alias
    UMLS CUI-1
    C1707492 (Consent Withdrawn)
    UMLS CUI-2
    C2347500 (Pharmacogenetic Test)
    Has subject withdrawn consent for PGx research?
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    Date of informed consent withdrawn
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Has a request been made for sample destruction?
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,2]
    C1948029 (Destruction (action))
    UMLS CUI [1,3]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    Reason for request for sample destruction
    Description

    Reason for request for sample destruction

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,2]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,3]
    C1948029 (Destruction (action))
    UMLS CUI [1,4]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    Retour au début de la page

    Similar models

    Pharmacogenetic research consent and withdrawal of consent

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

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