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Click here for an overview of features available in StudyTRAXStudytrax.
What 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 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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- Allows a variable group to be electronically signed which locks the values and prevents changes
- Versioning is required to enable Electronic Signatures
- Separate roles are available for users to sign and/or un-sign a variable group
- Variable groups are selected as to whether they can be electronically signed
- Each variable group that is being signed or un-signed is checked and a password entered
Examples
Feature | Data Entry Example | Report/Output Example |
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Adverse Events |
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Change Reason |
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Double Data Entry |
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Medications |
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Randomization |
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Screening |
Subject Login
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Versioning |
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Electronic Signatures |
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