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ID

16538

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Concomitant Medication Log. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Keywords

  1. 7/23/16 7/23/16 -
  2. 11/17/16 11/17/16 -
Uploaded on

July 23, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Concomitant Medication Log: CRF Wisconsin Madison

    Concomitant Medication Log: CRF Wisconsin Madison

    Header
    Description

    Header

    PI Name
    Description

    PI Name

    Data type

    text

    Protocol or IRB Number
    Description

    Protocol or IRB Number

    Data type

    integer

    Protocol Short Title
    Description

    Protocol Short Title

    Data type

    text

    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Subject ID
    Description

    Subject ID

    Data type

    integer

    Number of Page
    Description

    Number of Page

    Data type

    integer

    Total amount of pages
    Description

    Total amount of pages

    Data type

    integer

    Concomitant Medication Log
    Description

    Concomitant Medication Log

    Description

    #

    Data type

    integer

    Medication/ Non-drug Therapy
    Description

    Medication/ Non-drug Therapy

    Data type

    text

    Indication
    Description

    Indication

    Data type

    text

    Dose (per admin)
    Description

    Dose (per admin)

    Data type

    float

    Dose Units
    Description

    1= g 2= mg 3= ug 4= L 5= mL 6= IU 7= Other

    Data type

    text

    Schedule/Frequency
    Description

    1= QD (once a day) 2= BID (twice a day) 3= TID (three times a day) 4= QID (four times a day) 5= QOD (every other day) 6= QM (every month) 7= QOM (every other month) 8= QH (every hour) 9= AC (before meals) 10= PC (after meals) 11= PRN (as needed) 12= Other

    Data type

    text

    Dose Form
    Description

    1= Tablet 2= Capsule 3= Ointment 4=Suppository 5=Aerosol 6=Spray 7=Suspension 8= Patch 9=Gas 10=Gel 11=Cream 12=Powder

    Data type

    text

    Route of Administration
    Description

    1= Oral 2= Topical 3= Subcutaneous 4= Intradermal 5= Transdermal 6= Intraocular 7= Intramuscular 8= Inhalation 9= Intravenous 10= Intraperitoneal 11= Nasal 12= Vaginal 13= Rectal 14= Other

    Data type

    text

    Start Date
    Description

    Start Date

    Data type

    date

    End Date
    Description

    End Date

    Data type

    date

    Baseline Med
    Description

    Baseline Med

    Data type

    boolean

    Continuing at end of study
    Description

    Continuing at end of study

    Data type

    boolean

    Similar models

    Concomitant Medication Log: CRF Wisconsin Madison

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    PI Name
    Item
    PI Name
    text
    Protocol or IRB Number
    Item
    Protocol or IRB Number
    integer
    Protocol Short Title
    Item
    Protocol Short Title
    text
    Subject Initials
    Item
    Subject Initials
    text
    Subject ID
    Item
    Subject ID
    integer
    Number of Page
    Item
    Number of Page
    integer
    Total amount of pages
    Item
    Total amount of pages
    integer
    Item Group
    Concomitant Medication Log
    #
    Item
    #
    integer
    Medication/ Non-drug Therapy
    Item
    Medication/ Non-drug Therapy
    text
    Indication
    Item
    Indication
    text
    Dose (per admin)
    Item
    Dose (per admin)
    float
    Dose Units
    Item
    Dose Units
    text
    Schedule/Frequency
    Item
    Schedule/Frequency
    text
    Dose Form
    Item
    Dose Form
    text
    Route of Administration
    Item
    Route of Administration
    text
    Start Date
    Item
    Start Date
    date
    End Date
    Item
    End Date
    date
    Baseline Med
    Item
    Baseline Med
    boolean
    Continuing at end of study
    Item
    Continuing at end of study
    boolean

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