(list) Adverse Events - Change Reason - Double Data Entry - Electronic Signatures - Medications - Randomization - Screening - Subject Login - Versioning
Description (link to page help)
Overview (details)
Things to consider
Examples
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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
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.