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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

Adverse Events

Change Reason

Double Data Entry

Medications

Randomization

Screening

Subject Login

Examples

 

Versioning

 

 

Electronic Signatures

 

 

 

 

 

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