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  • All of a subject's adverse events are displayed on the Adverse Events tab of the Subject Overview page
  • Adverse Events that are not resolved are highlighted red
  • A PDF report of all adverse events for the project can be viewed/printed for a desired date range
  • Limitations
    • The variables cannot be modified
    • The report cannot be modified
  • An alternate option to using the StudyTRAX Adverse Events feature is to create a variable group with your custom variables and attach the variable group to a non-fixed interval

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  • A Medications tab is displayed on the Subject Overview page where all of a subject's medications are visible
  • Medications are selected from a list so they do not have to be typed
  • Medications that are available for selection must be added or imported into the central list
  • Medications in the central list must include:
    • Trade Name
    • Generic Name
    • Code (a unique identifier for the medication)
    • Unit of Measure
  • When Medications are entered for a subject they include:
    • Medication Name - selected from the list
    • Begin Date - must be entered in full date format - mm/dd/yyyy
    • End Date - optional but if entered must be in full date format - mm/dd/yyyy
    • Dose - must be entered in the unit of measure specified for the medication in the central list
    • # / Day - must be entered as a whole number although 0 can be used
    • Notes - an optional field
  • Data Sets
    • Medication Groups can be created to define dose equivalenc scales for related medications
    • Medication Groups can be exported in one column of a data set
    • Medication Group Dosage and Medication Grouop Exposure (has ever taken) can be exported for a medication group
    • Medication Dosage and Medication Exposure (has ever taken) can be exported for medications that are assigned to the project
      • Has Ever Taken:  Outputs a 0 (No) or 1 (Yes) if the subject has ever taken the medication
      • Dosage:  Outputs the dosage at an encounter based on the begin/end date of the medication and the date of the encounter
  • Limitations
    • The subject medication fields cannot be modified
    • Only medications assigned to a project can be exported through data sets
      Tip

      Medication Groups can be created from any medications in the central list and then exported

      {tip]

  • Alternate options
    •  Create a Project Variable Group that is a log of all subject medications
      • The variables can be customized
      • All of a subject's medications will be visible on one form
      • When exporting the data each medication will be in a separate column
    • Create an Encounter Variable Group and assign to a non-fixed encounter
      • The variables can be customized
      • Each medication will be a separate non-fixed interval
      • A subject report can list all of a subject's medications on one report
      • When exporting the data each medication will be in a column
      • When it is expected that subjects will have numerous medications this option will result in many non-fixed intervals

Examples

Feature

Example 1

Example 2

Adverse Events


Subject Overview page


Adverse Event Report

Change Reason


Data Entry Change Reason window


Auditing Report

Double Data Entry


Subject Overview Page



Double Data Entry Report

Medications

 

 

Randomization

 

 

Screening

 

 

Subject Login

 

 

Versioning

 

 

Electronic Signatures

 

 

 

 

 

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