ID

12097

Description

Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Keywords

Versions (3)
  1. 17/9/15 17/9/15 - Julian Varghese
  2. 22/9/15 22/9/15 - Julian Varghese
  3. 24/5/16 24/5/16 -
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22 de septiembre de 2015

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Creative Commons BY-NC 3.0 Legacy
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    Relapsing Remitting Multiple Sclerosis NCT02461069 - Visit 1 (Screening)

    English

    Patient administration and Medical History

    4 forms  
    Administration and Instructions for CRF Completion
    Description

    Administration and Instructions for CRF Completion

    Subject ID
    Description

    Format: [3-digit centre number] - [3-digit subject number]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Name (initials acceptable)
    Description

    Patient Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1299487
    Instructions for CRF Completion
    Description

    General advices: Please fill in the CRF pages promptly and legibly with an indelible black ballpoint. In case of missing values, please use the following abbreviations for documentation: NA = not available, not assessed, not applicable ND = not done NK = not known Necessary corrections on the CRF have to be carried out in accordance with GCP (which means: cross out with one line the wrong entry, write down the correct information next to the former entry and confirm with date and initials). The utilization of tipp-ex/whiteout is not allowed. Input format for date is dd-mm-yyyy, missing parts of date have to be marked with NK (e. g. “NK-01-2007”). Please be aware of the fact that the investigator or an authorised member of the investigator's staff has to sign at the designated positions to confirm completeness and correctness of entered data. The CRFs are provided as PDF documents. Please enter the Subject ID on the first page of the PDF and print out the required pages to start with documentation. The Subject ID will be printed in the header of each page automatically. • The original has to be sent to the destination address for CRFs. • A copy is kept at your trial site. Corrections after having sent the original to the destination address have to be carried out as follows: • Complete/correct the documentation on your trial site's copy. • Send these corrections to the destination address for CRFs and keep a copy of the corrected page(s) at your trial site.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C1442085
    Date of written Informed Consent
    Description

    Date of written Informed Consent

    Data type

    date

    Demographic Data
    Description

    Demographic Data

    Age
    Description

    Age

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1]
    C0001779
    years
    Sex
    Description

    Sex

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0150831
    Blood pregnancy test
    Description

    Blood pregnancy test

    Blood Pregnancy Test done, specify test date
    Description

    Blood Pregnancy Test done, specify test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0850355
    UMLS CUI [1,2]
    C0011008
    Result:
    Description

    Result:

    Data type

    text

    Alias
    UMLS CUI [1]
    C0427777
    Blood pregnancy test not done, reason:
    Description

    Blood pregnancy test not done, reason:

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0850355
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Testing for JC virus antibodies
    Description

    Testing for JC virus antibodies

    JC virus antibodies test done, specify test date:
    Description

    JC virus antibodies test done, specify test date:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3511565
    UMLS CUI [1,2]
    C0011008
    JC virus antibodies test not done, reason
    Description

    JC virus antibodies test not done, reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3511565
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    test
    Description

    test

    Data type

    text

    Medical History
    Description

    Medical History

    Medical History Description: Please state diagnosis, if known
    Description

    Medical History Description: Please state diagnosis, if known

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826738
    End Date
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826747
    Ongoing at Start of Study
    Description

    Medical History Ongoing

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826680
    MS Medical History
    Description

    MS Medical History

    Date of MS diagnosis
    Description

    Date of MS diagnosis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [1,3]
    C0011008
    Date of MS diagnosis unknown
    Description

    Date of MS diagnosis unknown

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0439673
    Date of first MS symptoms
    Description

    Date of first MS symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0574845
    Date of first MS symptoms unknown
    Description

    Date of first MS symptoms unknown

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0574845
    UMLS CUI [1,3]
    C0439673
    Number of relapses since MS diagnosis
    Description

    Number of relapses since MS diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C0449788
    Number of relapses since MS diagnosis unknown
    Description

    Number of relapses since MS diagnosis unknown

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0439673
    Number of relapses in the last 12 months
    Description

    Number of relapses in the last 12 months

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C0449788
    Number of relapses in the last 12 months unknown
    Description

    Number of relapses in the last 12 months unknown

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C0449788
    UMLS CUI [1,3]
    C0439673
    Onset date of most recent relapse
    Description

    Onset date of most recent relapse

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C1513491
    UMLS CUI [1,3]
    C0574845
    Onset date of most recent relapse unknown
    Description

    Onset date of most recent relapse unknown

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C1513491
    UMLS CUI [1,3]
    C0574845
    UMLS CUI [1,4]
    C0439673
    MS Treatment History
    Description

    MS Treatment History

    Active substance/nondrug therapy
    Description

    Name of the active substance:

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1254351
    UMLS CUI [2]
    C0599938
    Treatment of MS relapse
    Description

    Treatment of MS relapse

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0856120
    UMLS CUI [1,2]
    C0087111
    Start Date
    Description

    TreatmentStartDate

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0808070
    End Date
    Description

    TreatmentEndDate

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0806020
    ongoing
    Description

    ongoingtreatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0549178
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    Similar models

    Patient administration and Medical History

    4 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administration and Instructions for CRF Completion
    Patient Study ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Patient Name
    Item
    Patient Name (initials acceptable)
    text
    C1299487 (UMLS CUI [1])
    Instructions for CRF Completion
    Item
    text
    C1516308 (UMLS CUI [1,1])
    C1442085 (UMLS CUI [1,2])
    Date of written Informed Consent
    Item
    Date of written Informed Consent
    date
    Item Group
    Demographic Data
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI [1])
    Item
    Sex
    integer
    C0150831 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    male (m)
    CL Item
    female (f)
    Item Group
    Blood pregnancy test
    Blood Pregnancy Test done, specify test date
    Item
    Blood Pregnancy Test done, specify test date
    date
    C0850355 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Result:
    Item
    text
    C0427777 (UMLS CUI [1])
    Item
    Blood pregnancy test not done, reason:
    text
    C0850355 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Blood pregnancy test not done, reason:
    Code List
    Blood pregnancy test not done, reason:
    CL Item
    male participant (male participant)
    CL Item
    female participant with no childbearing potential (female participant with no childbearing potential)
    CL Item
    other: (other:)
    Item Group
    Testing for JC virus antibodies
    JC virus antibodies test done, specify test date:
    Item
    date
    C3511565 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    JC virus antibodies test not done, reason
    Item
    JC virus antibodies test not done, reason
    text
    C3511565 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    test
    Item
    text
    Item Group
    Medical History
    Medical History Description: Please state diagnosis, if known
    Item
    Medical History Description: Please state diagnosis, if known
    text
    C0011900 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C2826738 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C2826747 (UMLS CUI [1])
    Item
    Ongoing at Start of Study
    text
    C2826680 (UMLS CUI [1])
    Medical History Ongoing
    Code List
    Ongoing at Start of Study
    CL Item
    NO (N)
    CL Item
    YES (Y)
    Item Group
    MS Medical History
    Date of MS diagnosis
    Item
    Date of MS diagnosis
    date
    C0026769 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Date of MS diagnosis unknown
    Item
    Date of MS diagnosis unknown
    boolean
    C0026769 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0439673 (UMLS CUI [1,4])
    Date of first MS symptoms
    Item
    Date of first MS symptoms
    date
    C0026769 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Date of first MS symptoms unknown
    Item
    Date of first MS symptoms unknown
    boolean
    C0026769 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    C0439673 (UMLS CUI [1,3])
    Number of relapses since MS diagnosis
    Item
    Number of relapses since MS diagnosis
    integer
    C0856120 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of relapses since MS diagnosis unknown
    Item
    Number of relapses since MS diagnosis unknown
    text
    C0856120 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0439673 (UMLS CUI [1,3])
    Number of relapses in the last 12 months
    Item
    Number of relapses in the last 12 months
    text
    C0856120 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of relapses in the last 12 months unknown
    Item
    Number of relapses in the last 12 months unknown
    boolean
    C0856120 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    C0439673 (UMLS CUI [1,3])
    Onset date of most recent relapse
    Item
    Onset date of most recent relapse
    date
    C0856120 (UMLS CUI [1,1])
    C1513491 (UMLS CUI [1,2])
    C0574845 (UMLS CUI [1,3])
    Onset date of most recent relapse unknown
    Item
    Onset date of most recent relapse unknown
    text
    C0856120 (UMLS CUI [1,1])
    C1513491 (UMLS CUI [1,2])
    C0574845 (UMLS CUI [1,3])
    C0439673 (UMLS CUI [1,4])
    Item
    Active substance/nondrug therapy
    integer
    C1254351 (UMLS CUI [1])
    C0599938 (UMLS CUI [2])
    Active substance/nondrug therapy
    Code List
    Active substance/nondrug therapy
    CL Item
    1 Alemtuzumab (1)
    CL Item
    2 Azathioprine (2)
    CL Item
    3 Cyclophosphamide (3)
    CL Item
    4 Dimethyl fumarate  (4)
    CL Item
    5 Fingolimod (5)
    CL Item
    6 Glatiramer acetate (6)
    CL Item
    7 Immunoglobulins (7)
    CL Item
    8 Interferon beta (8)
    CL Item
    9 Methylprednisolone* (9)
    CL Item
    10 Mitoxantrone (10)
    CL Item
    11 Natalizumab (11)
    CL Item
    12 Rituximab (12)
    CL Item
    13 Teriflunomide (13)
    CL Item
    14 Other active substance (14)
    CL Item
    15 Physiotherapy (15)
    CL Item
    16 Plasmapheresis (16)
    CL Item
    17 Other Non-drug therapy (17)
    Treatment of MS relapse
    Item
    Treatment of MS relapse
    boolean
    C0856120 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    TreatmentStartDate
    Item
    Start Date
    date
    C0087111 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    TreatmentEndDate
    Item
    End Date
    date
    C0087111 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    ongoingtreatment
    Item
    ongoing
    boolean
    C0087111 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
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