Providing an eSignature
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.
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.
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.
To provide an eSignature:
- Click 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.
Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.
Role by Study 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:
|Standard Tab||Data Entry Tab||
Ability to access the Data Entry tab
Ability to provide an electronic signature on study data
Learn more about Study Roles.
eSignature is available to the EDC Investigator security profiles. If your vault uses custom security profiles, you must have the following permissions:
|Security Profile||Object: Casebook: Review for Signature: Edit||Ability to sign a Casebook|
|Security Profile||Object: Event: Review for Signature: Edit||Ability to sign a Event|
|Security Profile||Object: Form: Review for Signature: Edit||Ability to sign a Form|
|Security Profile||Object: Item: Review for Signature: Edit||Ability to sign a Item|