Before you work with this feature

For the 23.1.1 patch release, we've introduced a minor enhancement for this new feature. For more information, see the Other enhancements.

The following users can sign off at the form and visit level and manage custom affidavits:

• Users assigned the Approve and Sign Subject Data permission can sign at the casebook level and their signature is applied to all questions available to them based on their permissions. This permission also allows users to sign data that has been assigned to them in a signature configuration.
• Users assigned the Approve and Sign Assigned Data Only permission are only able to sign data that has been assigned for their role at the form or visit level in a signature configuration.
• Users assigned the Receive the Pending Signatures Notification permission will receive email notifications informing them when a signature, for a site they are assigned to, has reached the defined target date or become overdue.

  Note:

  The Signature Requests notification is only sent once the Send Reminder Through Email setting is configured to Yes.
• Sponsor users assigned the Manage Signature Settings permission have the ability to create and edit signature configurations.

More details on notifications and permissions for this feature can be found in the Notifications and Permissions Guide and the Add Users Guide after the Release Assessment Environment upgrade.

Details for sponsor users

As a sponsor user, here's what you should be aware of when it comes to your workflow:

• Signature configurations at the form and visit level are disabled until the Display signature elements for site staff and sponsors setting is configured to Yes in the Study Settings.

  Note:

  Signature configurations for casebook level signatures are still available when this setting is configured to No.
• The signature option is available in all study modes.
• If you are required to sign off at more than one level, signatures applied at a lower level fulfill those at a higher level only for that specific form or visit. For example, a signature at a form level fulfills visit or subject level requirements.

  Note:

  Signatures at a higher level do not fulfill those at a lower level, therefore, a signature at the subject level will not fulfill a form level requirement, requiring separate signatures.

  This only applies if the user signing is responsible for signing at the higher level, as well.

• The first value in the Affidavit's codelist will be used for subject level signatures if more than one affidavit is included in the codelist.
• Be aware that if a new visit is named the same as a deleted visit, both appear as options in the Signature Configuration.
• Signature icons and requirements for impacted visits are updated for a subject once data is entered into a question or form, when the given question or form is added or modified through Advanced Study Versioning (ASV).

Details for site users

When it comes to your workflow, here's what you should know:

• The Ready to Sign filter now includes incomplete forms and visits with signature requirements.
• In order to confirm data accuracy, the forms under the following signature configuration types require a re-signature after previously signed if they are deleted, hidden, or no longer require signing:
  • Subject level
  • Two-section form
  • Visit level

You can find additional information in the Site User Guide after the Release Assessment Environment upgrade.

Impact on reports

The following reports have been updated for this feature:

• Study Design report
• Subject Data report
• Subject Events report

More information on these report impacts can be found in the Reporting Guide after the Release Assessment Environment upgrade.