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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
Electronic Signatures
- Allows a variable groupAllows 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
Examples
Feature | Data Entry Example | Report/Output Example |
|---|---|---|
Adverse Events | | |
Change Reason | | |
Double Data Entry | | |
Medications | | |
Randomization | | |
Screening | | |
Subject Login |
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Versioning |
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Electronic Signatures |
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