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. Upon any data changes after a signature is applied, Vault invalidates your signature and requires you to sign again.

Proving and eSignature

Prerequisites

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


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?

At any time, you can sign a Form, Event, or Casebook when there are no open queries and any Forms are Submitted. When there are open queries, there are restrictions on what you can sign:

When there is an open, Event Date-level query:

  • You cannot sign at the Event Date level.
  • 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, Form-level query, but no Event-level query:

  • You cannot 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.

All Forms and Items must be in the Submitted status with no open queries for you to sign.

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.

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.