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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
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Examples

Feature

Example 1

Example 2

Adverse Events


Subject Overview page


Adverse Event Report

Change Reason

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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.

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