June 23, 2021 | Release Number: 21R1.3.02

New Document Types

You can now create documents of the following types:

• Insurance
• Protocol Clarification
• Protocol Summary of Changes

New Required Fields

When you create an IRB/IEC Response or IRB/IEC Submission document type, you are now required to select a response type or submission type, respectively.

Connected Studies

New Document Types

On a Connected Study, you can now send the following document types to a sponsor or CRO’s vault:

• Delegation of Authority
• Note to File
• Participant Information Sheet

Automatic State Change on Send to Sponsor/CRO for Draft Documents

On a Connected Study, you no longer need to update the status of the documents below to In Sponsor Review before sending to your sponsor or CRO’s vault. Instead, you can send the documents in a Draft state and SiteVault automatically updates the state to In Sponsor Review.

• Advertisement for Recruitment
• Confidentiality Agreement
• Contract
• Diary (blank)
• Informed Consent Form (blank)
• Participant Information Sheet
• Participant Materials - Other
• Participant Questionnaire (blank)
• Study Participation Card

June 4, 2021 | Release Number: 21R1.3.01

Set Context in Vault Selector

With this release, your research organization and site or sites are displayed in the Vault Selector. If you have access to more than one site, you can use Vault Selector to navigate among the sites. The study documents and information that you can view or manage are determined by the site that’s selected.

Add Document Fields in Bulk in Document Inbox

When you upload documents to the Document Inbox, a dialog is now displayed that enables you to apply document fields such as Study or Product to all of the documents at once.

Patient & Study Participant Data Quality

This feature adds the following support to ensure the quality of the data that is entered and maintained on patient and study participant records:

• SiteVault doesn’t allow you to associate more than one participant on a study with the same patient record.
• SiteVault doesn’t allow you to use the same email address for more than one patient.

Create User Page

We made minor updates to the layout and labels of the Create User page in preparation for upcoming enhancements to how you create users and assign system access and permissions in SiteVault. The Access & Permissions section is updated to System Access & Permissions, and the name of your site is displayed next to the list where you select the user’s system role (also known as user type).

Expanded Language Support

This release provides additional support for a more fully translated SiteVault into your own language. See the Managing Your Profile page for more information on updating your language.

Veeva eConsent - Resend Declined eConsent Forms

If a participant declines an eConsent form in error or changed their mind, you can now resend the same form. See [Processing Declined eConsent Forms](/gr/sitevault/econsent/declined-forms/ for more information.