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ID

14646

Description

NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Link

https://www.commondataelements.ninds.nih.gov/

Keywords

  1. 4/25/16 4/25/16 -
Uploaded on

April 25, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    NINDS CDE Drugs Epilepsy

    1. StudyEvent: ODM
      1. Drugs
    Anti Epileptic Drug (AED) Plasma Concentration Log
    Description

    Anti Epileptic Drug (AED) Plasma Concentration Log

    Study ID
    Description

    Study ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826693
    Study site name
    Description

    Study site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Line Number
    Description

    Line

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Generic Name of AED
    Description

    Generic Name of AED

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C0592502
    Number of line on AED Log
    Description

    Line on AED Log

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Date and Time of Blood Draw (mm/dd/yyyy hh:mm)
    Description

    Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    Amount of Last Dose Before Blood Draw (Specify Units)
    Description

    Amount of Last Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178602
    Please specify unit of medication dosage
    Description

    Units used

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Date and Time of Last Dose Before Blood Draw
    Description

    Date and Time of Last Dose Before Blood Draw

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C0945146
    Plasma Concentration Result
    Description

    Plasma Concentration

    Data type

    float

    Alias
    UMLS CUI [1]
    C0683150
    Plasma concentration please specify unit
    Description

    Plasma concentration

    Data type

    text

    Alias
    UMLS CUI [1]
    C0683150
    Plasma concentration:Not Done
    Description

    Plasma concentration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0683150
    Clinically Significant Non Adherence Expected/ Confirmed?
    Description

    Non Adherence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0376405
    Further comments
    Description

    Further comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830770
    Anti Epileptic Drug (AED) Resistance Log
    Description

    Anti Epileptic Drug (AED) Resistance Log

    Line number
    Description

    Line

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Antiepileptic drug name
    Description

    Please write in the information below for each AED that was taken by the subject in the past, including current AEDs. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0003299
    Antiepileptic drug formulation known?
    Description

    Antiepileptic drug

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C1705957
    Antiepileptic drug: if formulation is known, please specify
    Description

    IR, ER, liquid...

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C1705957
    AED Schedule Known?
    Description

    (e.g., TID, BID)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C0040808
    Antiepileptic drug schedule is known, please specify
    Description

    (TID; BID...)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C0040808
    Reason for discontinuation known?
    Description

    Reason for discontinuation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0457454
    Reason for discontinuation: please specify
    Description

    Reason for discontinuation

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457454
    Was antiepileptic drug appropriate for the epilepsy syndrome?
    Description

    Was antiepileptic drug appropriate for the epilepsy syndrome?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C3640049
    Was 3 months of therapy achieved without discontinuation due to adverse events?
    Description

    3 months of therapy achieved without discontinuation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0580352
    Were attempts made to adjust dose? (not titration)
    Description

    Dose adjustment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1299575
    Did the subject continue to have seizures on this AED despite dose adjustment?
    Description

    Seizures

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036572
    Are the answers to all the previous questions known?
    Description

    Answers known

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1822117
    Are the answers to all the previous questions “Yes”?
    Description

    Positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1446409
    Anti Epileptic Drug (AED) Log
    Description

    Anti Epileptic Drug (AED) Log

    Did the subject take any non-study antiepileptic drugs during the study?
    Description

    Please record all non-study AEDs the participant/subject took while participating in the study. Enter each dose change on a new line

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003299
    Name of Antiepileptic Drug
    Description

    Antiepileptic Drug

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003299
    UMLS CUI [1,2]
    C0592503
    Generic or Brand used?
    Description

    Generic or Brand Used?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0085155
    UMLS CUI [1,2]
    C0590772
    Formulation
    Description

    (e.x., extended release, liquid, sprinkle, etc.)

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705957
    Dosing Schedule -Times of Administration
    Description

    (00:00-24:00; 99:99=Unknown, 88:88=N/A)

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040808
    Dosing Schedule -Times of Administration: N/A - taken PRN
    Description

    Dosing Schedule -Times of Administration

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040808
    Dosing Schedule -Times of Administration: Average frequency = times per month
    Description

    Dosing Schedule -Times of Administration

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0040808
    Dose
    Description

    Medication Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C3174092
    Unit of dosage
    Description

    Unit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348328
    Route of administration
    Description

    Route of administration

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Description

    Treatment Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    End Date
    Description

    Treatment End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    ongoing
    Description

    ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    If Applicable, Reason for Discontinuation
    Description

    (Check all that apply)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0457454
    Reason for Discontinuation:please specify
    Description

    Reason for Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457454
    Further comments
    Description

    Further comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830770
    Non Anti Epileptic Medication Log
    Description

    Non Anti Epileptic Medication Log

    Did the participant/subject take any medications days before or during the study?
    Description

    Record all medications the participant/subject was taking at the time of study enrollment (and/or during a protocol-specified period prior to study participation) and all non-study medications the participant/subject took while participating in the study. These can include prescription medications, over the counter drugs, vitamins, supplements, minerals, complementary/alternative medications, etc.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Line number
    Description

    Line

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Generic Name of Medication
    Description

    Generic Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0592502
    Dose Frequency
    Description

    Dose Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826654
    Dose frequency N/A-taken PRN
    Description

    Dose frequency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826654
    Dose frequency Average frequency= times per month
    Description

    Dose frequency

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826654
    Total Daily Dose or PRN Dose
    Description

    Total Daily Dose or PRN Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348070
    UMLS CUI [2]
    C0558288
    Dosage unit
    Description

    Unit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348328
    Dosage unit: if other please specify
    Description

    unit

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348328
    Start date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Measurement units
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C2826734
    dd/mm/yy
    Concomitant Medication: End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Ongoing
    Description

    Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696

    Similar models

    Drugs

    1. StudyEvent: ODM
      1. Drugs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Anti Epileptic Drug (AED) Plasma Concentration Log
    Study ID
    Item
    Study ID
    text
    C2826693 (UMLS CUI [1])
    Study site
    Item
    Study site name
    text
    C2825164 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Line
    Item
    Line Number
    integer
    C0750480 (UMLS CUI [1])
    Generic Name of AED
    Item
    Generic Name of AED
    text
    C0003299 (UMLS CUI [1,1])
    C0592502 (UMLS CUI [1,2])
    Line on AED Log
    Item
    Number of line on AED Log
    integer
    C0750480 (UMLS CUI [1])
    Date and Time
    Item
    Date and Time of Blood Draw (mm/dd/yyyy hh:mm)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Amount of Last Dose
    Item
    Amount of Last Dose Before Blood Draw (Specify Units)
    integer
    C0178602 (UMLS CUI [1])
    Units used
    Item
    Please specify unit of medication dosage
    text
    C1519795 (UMLS CUI [1])
    Date and Time of Last Dose Before Blood Draw
    Item
    Date and Time of Last Dose Before Blood Draw
    datetime
    C0945146 (UMLS CUI [1])
    Plasma Concentration
    Item
    Plasma Concentration Result
    float
    C0683150 (UMLS CUI [1])
    Plasma concentration
    Item
    Plasma concentration please specify unit
    text
    C0683150 (UMLS CUI [1])
    Plasma concentration
    Item
    Plasma concentration:Not Done
    boolean
    C0683150 (UMLS CUI [1])
    Non Adherence
    Item
    Clinically Significant Non Adherence Expected/ Confirmed?
    boolean
    C0376405 (UMLS CUI [1])
    Further comments
    Item
    Further comments
    text
    C1830770 (UMLS CUI [1])
    Item Group
    Anti Epileptic Drug (AED) Resistance Log
    Line
    Item
    Line number
    integer
    C0750480 (UMLS CUI [1])
    Antiepileptic drug
    Item
    Antiepileptic drug name
    text
    C0003299 (UMLS CUI [1])
    Antiepileptic drug
    Item
    Antiepileptic drug formulation known?
    boolean
    C0003299 (UMLS CUI [1,1])
    C1705957 (UMLS CUI [1,2])
    Antiepileptic drug
    Item
    Antiepileptic drug: if formulation is known, please specify
    text
    C0003299 (UMLS CUI [1,1])
    C1705957 (UMLS CUI [1,2])
    Antiepileptic drug schedule
    Item
    AED Schedule Known?
    boolean
    C0003299 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Antiepileptic drug schedule
    Item
    Antiepileptic drug schedule is known, please specify
    text
    C0003299 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Item
    Reason for discontinuation known?
    integer
    C0457454 (UMLS CUI [1])
    Code List
    Reason for discontinuation known?
    CL Item
    Idiosyncratic Side Effect(s), specify (1)
    CL Item
    Dose Related Side Effect(s), specify (2)
    CL Item
    Chronic Side Effects (3)
    CL Item
    Inadequate Seizure Control (4)
    CL Item
    Other, specify (5)
    Reason for discontinuation
    Item
    Reason for discontinuation: please specify
    text
    C0457454 (UMLS CUI [1])
    Was antiepileptic drug appropriate for the epilepsy syndrome?
    Item
    Was antiepileptic drug appropriate for the epilepsy syndrome?
    boolean
    C0003299 (UMLS CUI [1,1])
    C3640049 (UMLS CUI [1,2])
    Item
    Was 3 months of therapy achieved without discontinuation due to adverse events?
    integer
    C0580352 (UMLS CUI [1])
    Code List
    Was 3 months of therapy achieved without discontinuation due to adverse events?
    CL Item
    Yes  (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item
    Were attempts made to adjust dose? (not titration)
    integer
    C1299575 (UMLS CUI [1])
    Code List
    Were attempts made to adjust dose? (not titration)
    CL Item
    Yes  (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Seizures
    Item
    Did the subject continue to have seizures on this AED despite dose adjustment?
    boolean
    C0036572 (UMLS CUI [1])
    Answers known
    Item
    Are the answers to all the previous questions known?
    boolean
    C1822117 (UMLS CUI [1])
    Positive
    Item
    Are the answers to all the previous questions “Yes”?
    boolean
    C1446409 (UMLS CUI [1])
    Item Group
    Anti Epileptic Drug (AED) Log
    Non-study antiepileptic drugs
    Item
    Did the subject take any non-study antiepileptic drugs during the study?
    boolean
    C0003299 (UMLS CUI [1])
    Antiepileptic Drug
    Item
    Name of Antiepileptic Drug
    text
    C0003299 (UMLS CUI [1,1])
    C0592503 (UMLS CUI [1,2])
    Item
    Generic or Brand used?
    integer
    C0085155 (UMLS CUI [1,1])
    C0590772 (UMLS CUI [1,2])
    Code List
    Generic or Brand used?
    CL Item
    Generic (1)
    CL Item
    Brand (2)
    CL Item
    Unknown (3)
    Formulation
    Item
    Formulation
    text
    C1705957 (UMLS CUI [1])
    Dosing Schedule -Times of Administration
    Item
    Dosing Schedule -Times of Administration
    time
    C0040808 (UMLS CUI [1])
    Dosing Schedule -Times of Administration
    Item
    Dosing Schedule -Times of Administration: N/A - taken PRN
    boolean
    C0040808 (UMLS CUI [1])
    Dosing Schedule -Times of Administration
    Item
    Dosing Schedule -Times of Administration: Average frequency = times per month
    integer
    C0040808 (UMLS CUI [1])
    Medication Dose
    Item
    Dose
    float
    C3174092 (UMLS CUI [1])
    Item
    Unit of dosage
    integer
    C2348328 (UMLS CUI [1])
    Code List
    Unit of dosage
    CL Item
    gram (g )
    CL Item
    grain (gr )
    CL Item
    drop (gtt )
    CL Item
    microgram (mcg )
    CL Item
    microliter (mcL )
    CL Item
    milligram (mg )
    CL Item
    milliliter (mL )
    CL Item
    ounce (oz )
    CL Item
    spray/squirt (SPY )
    CL Item
    suppository (supp )
    CL Item
    tablespoon (TBSP )
    CL Item
    teaspoon (Sp )
    CL Item
    other, specify (OTH )
    CL Item
    Unknown (UNK)
    Route of administration
    Item
    Route of administration
    text
    C0013153 (UMLS CUI [1])
    Treatment Start Date
    Item
    Start Date
    date
    C3173309 (UMLS CUI [1])
    Treatment End Date
    Item
    End Date
    date
    C1531784 (UMLS CUI [1])
    ongoing
    Item
    ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Item
    If Applicable, Reason for Discontinuation
    integer
    C0457454 (UMLS CUI [1])
    Code List
    If Applicable, Reason for Discontinuation
    CL Item
    Idiosyncratic Side Effect(s), specify (1)
    CL Item
    Dose Related Side Effect(s), specify (2)
    CL Item
    Chronic Side Effects (3)
    CL Item
    Inadequate Seizure Control (4)
    CL Item
    Other, specify (5)
    Reason for Discontinuation
    Item
    Reason for Discontinuation:please specify
    text
    C0457454 (UMLS CUI [1])
    Further comments
    Item
    Further comments
    text
    C1830770 (UMLS CUI [1])
    Item Group
    Non Anti Epileptic Medication Log
    Concomitant medication
    Item
    Did the participant/subject take any medications days before or during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Line
    Item
    Line number
    integer
    C0750480 (UMLS CUI [1])
    Generic Name
    Item
    Generic Name of Medication
    text
    C0592502 (UMLS CUI [1])
    Dose Frequency
    Item
    Dose Frequency
    text
    C2826654 (UMLS CUI [1])
    Dose frequency
    Item
    Dose frequency N/A-taken PRN
    boolean
    C2826654 (UMLS CUI [1])
    Dose frequency
    Item
    Dose frequency Average frequency= times per month
    integer
    C2826654 (UMLS CUI [1])
    Total Daily Dose or PRN Dose
    Item
    Total Daily Dose or PRN Dose
    integer
    C2348070 (UMLS CUI [1])
    C0558288 (UMLS CUI [2])
    Item
    Dosage unit
    integer
    C2348328 (UMLS CUI [1])
    Code List
    Dosage unit
    CL Item
    gram (g )
    CL Item
    grain (gr )
    CL Item
    drop (gtt )
    CL Item
    microgram (mcg )
    CL Item
    microliter (mcL )
    CL Item
    milligram (mg )
    CL Item
    milliliter (mL )
    CL Item
    ounce (oz )
    CL Item
    spray/squirt (SPY )
    CL Item
    suppository (supp )
    CL Item
    tablespoon (TBSP )
    CL Item
    teaspoon (Sp )
    CL Item
    other, specify (OTH )
    CL Item
    Unknown (UNK)
    unit
    Item
    Dosage unit: if other please specify
    text
    C2348328 (UMLS CUI [1])
    Concomitant Medication Start Date
    Item
    Start date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    Concomitant Medication: End Date
    date
    C2826744 (UMLS CUI [1])
    Ongoing
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C2826696 (UMLS CUI [1])

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