Providing Signatures

You can sign and date in Vault using eSignature. Vault eSignature meets the requirements of FDA 21 CFR Part 11. You can sign at the Form, Event, or Casebook (Subject) level and the signature will apply to all eligible forms and event dates. Upon any data changes after a signature is applied, Vault invalidates your signature and requires you to sign again.

If your study is using Data Model 2 and the Enable Bulk Casebook Signature feature is configured, you can bulk sign all eligible Subjects at a Site. Contact Veeva Support to enable this feature then configure at the Study level in EDC Tools > Study Settings.

Proving and eSignature

Prerequisites

Configuration

Before you can provide a signature in your Study, a study designer must first create a casebook-type Signature Definition in Studio.

Required Permissions

Users with the standard CDMS Principal Investigator application role can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab Data Entry Tab

Ability to access the Data Entry tab
Functional Permission Sign

Ability to provide an electronic signature on study data

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Vault supports authenticating with a Single Sign-on (SSO) provider when performing the following actions:

Data Entry:

  • Signing at the Form or Casebook level
  • Accepting Study closeout PDFs

Randomization:

  • Emergency Unmasking
  • Reveal treatment
  • Redispense Kit/Device
  • Verify list

Labs:

  • Updating Normal Ranges that are In Use

When Can You Sign?

You can sign a Form or Event when the following conditions are met:

  • Any Forms are Submitted
  • The Form, Event, and Casebook are unlocked
  • There are no open queries (ability to sign depends on the signature level)

When there is an open query on an Event:

  • You can’t sign Event Dates or Visit Methods on the Event.
  • You can sign Forms within that Event.
  • You can sign at the Casebook level, but Vault only applies your signature to Event Dates with no open queries. Vault then applies your signature to all Forms, including those in the Event.

When there is an open query on an Item, but there is no open query on the Event Date:

  • You can’t sign a Form with an open query.
  • You can sign at the Event level, but Vault only applies your signature to Forms with no open queries.

If your study is using Data Model 2 and the Enable Sign with Open Queries feature is configured, you can sign Forms and Event Dates with open queries. Contact Veeva Support to enable this feature then configure at the Study level in EDC Tools > Study Settings.

How to Sign

You sign by entering your login credentials (username and password) for the vault. Note that Vault prevents you from using saved passwords for compliance reasons. Even if you’ve saved your password in your browser or a password manager, you’ll have to type the password to provide an eSignature.

The Sign button and Sign Form action only display for users that have permission to provide signatures.

To provide an eSignature:

  1. Click Sign:
  2. Select the events to sign.

  3. Click Continue to provide your eSignature. Providing an eSignature

  4. Enter your login credentials in the Apply Electronic Signature dialog.
  5. Click Complete.

Bulk Casebook Signature

If your study is using Data Model 2 and the Enable Bulk Casebook Signature feature is configured, you can bulk sign all eligible Subjects at a Site. Contact Veeva Support to enable this feature then configure at the Study level in the Study Settings and Sites tabs in EDC Tools.

To bulk sign:

  1. Select the Sign Casebooks button at the top right hand corner of the page after navigating to your Subject list. Bulk Casebook Signature

  2. Choose where to apply the signature: All Eligible Subjects or Selected Subjects.
  3. If you chose Selected Subjects, select the checkbox next to each Subject you’d like to apply the signature.
  4. Click Sign Now.

You can also bulk sign from the Site listing page by selecting the Sign Casebooks option from the Site’s Actions Menu. Bulk Casebook Signature

How to Clear a Signature

To clear an eSignature:

  1. Select the Clear Signature action:
    • For a Form, open the Form and click on Clear Signature.
    • For a subject Casebook click Clear Casebook Signature from the casebook schedule.
    • For an Event, click Clear Event Signature from the Form’s Actions Menu.
  2. In the Clear Signature dialog, click Clear Signature.