Creating Signature Definitions

After creating your Study, you can create Signature Definitions from Studio > Settings. Note that the _Signature Definition is not versioned.

A Signature Definition defines the Meaning and Legal Reason associated with a user’s electronic signature in Vault CDMS.

The buttons and actions related to signatures will not display for site users until you create signature definitions of the necessary types. In order for your investigators in your Study to provide eSignatures, you must create a Signature Definition to your Study using the Casebook type. For your site users to review and accept closeout PDFs, you must create a Signature Definition using the Study Closeout type.

Known Issue: In the current release, Vault EDC doesn’t support eSignatures when using Single Sign-on (SSO) for authentication.

Create a Signature Definition

To create your study’s Signature Definition:

  1. Navigate to your Study in Studio.
  2. Scroll to Settings > Signature Definitions.
  3. Click + New Signature Definition. New Signature Definition button

  4. In the Signature Definition dialog:
    • Select a Type. Note that you can only have one Signature Definition per type.
    • Select a signature Methodology from the drop-down list.
    • Enter a Meaning for signatures in your study.
    • Enter a Legal Reason for signatures in your study.
    • Optional: Enter an External ID for your Signature Definition. Signature Definition dialog
  5. Click Save.
  6. Vault saves your changes and applies them to any future signatures in your Study.

Edit a Signature Definition

You can edit your Signature Definition as needed from Studio > Settings. Editing the Signature Definition when there are already signed forms in your study invalidates all existing signatures. Any signed forms revert to the Completed status. Investigators will have to re-sign all previously signed forms.

To edit your Signature Definition:

  1. Locate your Signature Definition in Settings > Signature Definitions.
  2. Hover over the Signature Definition to show the Actions menu.
  3. From the Actions menu, select Edit. Edit action

  4. Make any required changes in the Signature Definition dialog.
  5. Click Save.
  6. Vault saves your changes and applies them to any future signatures in your Study.

Delete a Signature Definition

You can delete a Signature Definition as long as no users in that study have provided a signature using that definition.

To delete a Signature Definition:

  1. Locate your Signature Definition in Settings > Signature Definitions.
  2. Hover over the Signature Definition to show the Actions menu.
  3. From the Actions menu, select Delete. Delete action

  4. Vault deletes the Signature Definition.

Next Steps

Once you finish configuring your Study, you can move on to creating your study’s design in the rest of Studio.