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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

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

Examples

 

Versioning

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Electronic Signatures

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