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42790

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Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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Versies (5)
  1. 05-10-17 05-10-17 -
  2. 22-02-18 22-02-18 -
  3. 22-02-18 22-02-18 -
  4. 22-02-18 22-02-18 -
  5. 17-09-21 17-09-21 -
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17 september 2021

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    Ropinirole Case Report Form GSK RRL100013

    Engels

    STATUS OF TREATMENT BLIND

    9 Formulieren  
    Status
    Beschrijving

    Status

    Was the treatment blind broken during the study?
    Beschrijving

    If Yes, complete the following

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0749659
    UMLS CUI [1,2]
    C2347038
    Date blind broken
    Beschrijving

    Date blind broken

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2347038
    Reason blind broken
    Beschrijving

    Complete Non-Serious Adverse Events or Serious Adverse Event pages, as appropriate.

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0392360
    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
    Beschrijving

    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS

    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
    Beschrijving

    The question "Has informed consent been obtained for PGx-Pharmacogenetic research?" should be completed at the beginning of the study. If the question is answered No, I/ one box for reason and do not complete the remainder of the page. WITHDRAWAL OF CONSENT The question "Has the subject withdrawn consent for PGx-Pharmacogenetic research?" must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section below completed. BLOOD SAMPLE DESTRUCT/ON Do not complete this section if a blood sample was not collected. The question "Has a request been made for sample destruction?" must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research. If the question is answered Yes, I/one box for reason.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C1442085
    PGx-PHARMACOGENETIC RESEARCH
    Beschrijving

    PGx-PHARMACOGENETIC RESEARCH

    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
    Beschrijving

    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Beschrijving

    Informed consent if yes

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2985782
    Informed consent if no
    Beschrijving

    Informed consent if no

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0021430
    Has a blood sample been collected for PGx-pharmacogenetic research?
    Beschrijving

    BLOOD SAMPLE COLLECTION

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    If Yes, record the date sample taken
    Beschrijving

    If Yes, record the date sample taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Beschrijving

    WITHDRAWAL OF CONSENT

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1707492
    BLOOD SAMPLE DESTRUCTION
    Beschrijving

    BLOOD SAMPLE DESTRUCTION

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    If Yes: BLOOD SAMPLE DESTRUCTION
    Beschrijving

    If Yes: BLOOD SAMPLE DESTRUCTION

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    CONCOMITANT MEDICATIONS
    Beschrijving

    The following lists of abbreviations are examples which can be used to aid the completion of the appropriate items on the Concomitant Medications page. These are not all inclusive lists and are for guidance only, other abbreviations not listed may be used if necessary.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2347852
    UNITS
    Beschrijving

    UNITS

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519795
    Terug naar het begin van de pagina

    Similar models

    STATUS OF TREATMENT BLIND

    9 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Status
    Was the treatment blind broken during the study?
    Item
    Was the treatment blind broken during the study?
    boolean
    C0749659 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    Date blind broken
    Item
    Date blind broken
    datetime
    C0011008 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    Item
    Reason blind broken
    integer
    C0392360 (UMLS CUI [1])
    Reason blind broken
    Code List
    Reason blind broken
    CL Item
    Medical emergency requiring identification of investigation al product for further treatment (1)
    C0013961 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other, specify (2)
    C1521902 (UMLS CUI-1)
    (Comment:en)
    Item Group
    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
    Item
    PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
    text
    C0031325 (UMLS CUI [1,1])
    C1442085 (UMLS CUI [1,2])
    Item Group
    PGx-PHARMACOGENETIC RESEARCH
    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
    Item
    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Item
    If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C2985782 (UMLS CUI [1])
    Item
    Informed consent if no
    text
    C0021430 (UMLS CUI [1])
    Informed consent if no
    Code List
    Informed consent if no
    CL Item
    Subject declined (Subject declined)
    CL Item
    Subject not asked by Investigator (Subject not asked by Investigator)
    CL Item
    Other, specify (Other, specify)
    BLOOD SAMPLE COLLECTION
    Item
    Has a blood sample been collected for PGx-pharmacogenetic research?
    boolean
    C0005834 (UMLS CUI [1])
    If Yes, record the date sample taken
    Item
    If Yes, record the date sample taken
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    WITHDRAWAL OF CONSENT
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C1707492 (UMLS CUI [1])
    BLOOD SAMPLE DESTRUCTION
    Item
    BLOOD SAMPLE DESTRUCTION
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    Item
    If Yes: BLOOD SAMPLE DESTRUCTION
    integer
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    If Yes: BLOOD SAMPLE DESTRUCTION
    Code List
    If Yes: BLOOD SAMPLE DESTRUCTION
    CL Item
    Subject requested (1)
    CL Item
    Other, specify (2)
    CONCOMITANT MEDICATIONS
    Item
    CONCOMITANT MEDICATIONS
    text
    C2347852 (UMLS CUI [1])
    Item
    UNITS
    text
    C1519795 (UMLS CUI [1])
    UNITS
    Code List
    UNITS
    CL Item
    Tablet (TAB)
    C0039225 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Micro litre (MCL)
    C1519795 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Millilitre (ML)
    (Comment:en)
    CL Item
    Litre (L)
    (Comment:en)
    CL Item
    Microgram (MCG)
    (Comment:en)
    CL Item
    Milligram (MG)
    (Comment:en)
    CL Item
    Gram (G)
    (Comment:en)
    CL Item
    Optional therapeutic specific code (?)
    (Comment:en)
    CL Item
    Optional therapeutic specific code (?)
    Terug naar het begin van de pagina 

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