April 2, 2021 | Release Number: 20R3.5.03

Delete Legacy Source Documents

With this release, Regulatory users can delete legacy source documents (those created before January 1, 2021) that are in a Final state. When you delete a finalized document, SiteVault also permanently deletes all versions of the document, including any draft or superseded versions.

SiteVault retains an audit trail of the document for compliance purposes, but you cannot access or recover the document’s file or content. Regulatory users can view and download the document audit trail in the Reporting > Deleted Document Records tab.

Veeva eConsent

This release enables you to reconsent participants who are in an Enrolled status. See the Reconsenting Participants page for more information on how to reconsent participants using SiteVault and MyVeeva for Patients.

March 18, 2021 | Release Number: 20R3.5.02

Document Delete With Audit Trail Access

With this release, Regulatory users can now delete documents that are in a steady state (such as Approved for Use, Current, or Final). When you delete a steady-state document, SiteVault also permanently deletes all versions of the document, including any draft or superseded versions.

SiteVault retains an audit trail of the document for compliance purposes, but you cannot access or recover the document’s file or content. Regulatory users can view and download the audit trails in a new Reporting > Deleted Document Records tab.

Connected Studies

With this release, you can now add comments when sending documents to a sponsor or CRO on a connected study. This enables you to communicate with sponsors or CROs about exchanged documents directly in SiteVault.

Also, if a sponsor or CRO sends a template of the following document types, the document must be copied before it can be returned:

• Advertisement for Recruitment
• Diary (blank)
• Informed Consent Form (blank)
• Participant Materials - Other
• Participant Questionnaire (blank)
• Study Participant Card

Lastly, Regulatory users can now send Confidentiality Agreement and Contract document types.

March 5, 2021 | Release Number: 20R3.5.01

Email Cross-Checks & User Administration Updates

This release updates the process by which you create or add users to your site. You no longer need to know whether a user is an existing Vault user. Instead, SiteVault now checks whether an email address is associated with an existing user.

Source Documents

When uploading source documents in the Source Upload tab, the date that you include in the filename is automatically added to the End Date field of the uploaded document. Previously, the date was added to the Start Date field.

Share Profiles Across Sites

When you create a new organization, product, or patient record, you can now choose whether the record should be shared across all sites in your research organization or only to one specific site.

For any existing records created before this release, SiteVault automatically assigns the records to the site. You can edit any existing records to be available across your research organization.

Connected Studies

A special icon now is displayed on studies with an active connected study agreement. This enables you to more easily identify which studies are available for exchanging study documents directly with a sponsor or CRO’s vault using SiteVault.