Overview

Click here for a list of features available in StudyTRAX.

Things to Consider

Adverse Events

• 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

Change Reason

• When a subject's data is modified the user will be prompted to enter a reason for the data change
• All data changes are tracked in an audit log even if Change Reason is not enabled

Double Data Entry

• A Double Data Entry Delta Report displays error rates and discrepancies between primary and secondary entries
• Only primary entry values are exportable through data sets
• The variables to be double data entered are selected
• The subject's which will be double data entered are selected

Medications

• 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

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

• 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
      

Randomization

Examples

Always create the simplest project configuration possible. If you are not sure that your project requires a feature, do not enable the feature as most features can be enabled later. Once a feature is enabled and data is entered, it may not be able to be disabled. However, Randomization and Screening cannot be enabled once subjects are enrolled in the project.