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- Used to allow subjects to log in and enter data
- Subjects are set up with their own username and password from the Subject Overview page (by users with a Subject Administration role)
- Subjects will only see the forms that are selected
- See the Subject Data Entry page for more details
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Versioning
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- This is not a common feature and complicates the project setup, verify this feature is desired before enabling
- Versioning must be enabled to use Electronic Signatures
- Unless you are testing the feature, do not turn it on until all the variable groups are created
- With versioning enabled every change to a variable group requires a new version
- Subjects that had data entered using a previous version can be upgraded to the new version of the variable group
- Limitations
- You cannot select which version a subject will be upgraded to, they can only be upgraded to the latest version
- Correcting errors when there are a lot of subjects and/or encounters would require upgrading for each subject's encounter
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Electronic Signatures
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- Allows a variable group
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 |
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Subject Login |
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Versioning |
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Electronic Signatures |
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