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.
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:
|Standard Tab||Data Entry Tab||
Ability to access the Data Entry tab
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:
- Signing at the Form or Casebook level
- Accepting Study closeout PDFs
- Emergency Unmasking
- Reveal treatment
- Redispense Kit/Device
- Verify list
- Updating Normal Ranges that are In Use
When Can You Sign?
You can sign a Form, Event, or Casebook 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 Date:
- You can’t 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 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.
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:
- Click Sign:
- Select the events to sign.
- Enter your login credentials in the Apply Electronic Signature dialog.
- Click Complete.
How to Clear a Signature
To clear an eSignature:
- 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.
- In the Clear Signature dialog, click Clear Signature.