Define signature configurations at the casebook level

Configure the casebook signature for your study to define the requirements to sign an entire subject's casebook. The Casebook Signature configuration is generated by default and it is listed as required by all roles with the Approve and sign subject data permission.

Users assigned the Manage signature settings permission have the ability to further define casebook level signature configurations.

Before performing this task, see Understand signature configurations to understand the specifics of signature configurations.

If you want to define signature configuration required on specific visits or forms, see Define a signature configuration at the form or visit level.

Note:

Standalone signature configurations (required at the form or visit level) and casebook level signature configurations, are mutually exclusive.
  1. Open the study settings.
  2. Navigate to the Signature Configuration tab.
  3. Along the top, select a specific mode:
    • Production Mode
    • Testing Mode
    • Training Mode
  4. Identify the Casebook Signature configuration that is auto-generated, and update the configurable fields.
    1. Configure the frequency:

      Note:

      If you set a frequency for the Casebook Signature, additional signatures will be required when there is unsigned data present for the subject's casebook. Once all data has been signed, no additional signatures will be required.
      Setting Description
      Set Frequency toggle
      • Set the Set Frequency toggle On to configure a frequency of how often the casebook is required to be signed.
      • Set the Set Frequency toggle Off if there is no specific frequency for signature requirements to be evaluated.

        Note: If the Set Frequency toggle is off, there won't be any other settings to define for the frequency.

      Every Enter the number of days that must pass after there is any unsigned or never signed subject data for a casebook level signature to be required. You can manually enter a number or use the up and down arrows.
      Send Reminder Through Email

      Configure whether to send email reminders regarding overdue signatures, by setting the Send Reminder Through Email On or Off.

      Note: You only receive notifications of overdue signature at sites that you are assigned to, and only if you are assigned the Receive the Pending Signatures Notification permission.

    2. Defined whether the casebook signature should be required or optional.
      • Set the Required toggle On if casebook signature should be required.
      • Set the Required toggle Off if casebook signature should be optional.

      Note:

      As casebook signatures become optional they are not taken into account in the overall sign status of each element (form or visit). For more information, see Understand signature configurations.
  5. Click Apply Changes.
  6. Read the confirmation message in the Success dialog, and click OK.
When any of these settings are updated, either from ON to OFF or vice versa, this change in configuration is handled asynchronously. This means it may take up to 60 minutes for new or updated signature requests to apply in your study.