SiteVault Release Highlights

---

SiteVault eISF

Document Access Enhancements

Restricted Documents

The Restricted Documents functionality is a tool for restricting visibility to specific study documents. Sites can mark a document as Restricted, making it visible only to users granted access to Restricted documents (at the study level).

The following new actions and fields support this functionality:

• Document Actions
  • Change to Restricted and Change to Not Restricted actions are present on document action menus.
  • The Restricted field in the document metadata (and in eBinder as a column) indicates whether the document is Restricted (field = Restricted) or Not Restricted (field = blank).
• User Access to Restricted Documents Fields
  • Access to restricted documents? field is present on the user account and team assignment creation pages.
  • Access to restricted documents? column is present on the Study > Team table and the Study assignment page. Options are Yes or No.
• Study Archive Action
  • A check for restricted documents is present on the Study Archive action.

Share Site Documents with External Users

Site Administrators can grant Monitors or External Users access to Site Documents categorized as Standard Operating Procedures, Policy Memos, or Work Instructions.

This feature includes the following changes:

• Adds the Grant Monitor/External User Visibility action to document menus for granting visibility.
• Adds the Revoke Monitor/External User Visibility action to document menus for removing visibility.
• Adds the Shared with Monitor/External Users? document field to documents of the Standard Operating Procedure, Policy Memos, and Work Instruction document types.
• Adds the View SOP, Policy Memos, and Work Instruction Documents link to the Monitor/External User view of the Study eBinder when the user has been granted visibility. This link navigates to a report of the available documents.

Updates to User Access and Study Assignment

Change Study Principal Investigator

The Change PI action is available from the View Study Details drawer’s All Action menu. Administrators can select this action to replace the current Principal Investigator (PI) with a new one. Users are guided through the process and can automate likely next steps. Studies enabled with Digital Delegation will require the new PI to approve the change, which updates the delegation log.

Assign Staff to Study upon Associated Document Upload

SiteVault will automatically assign staff to a study when a Study eBinder upload includes a Person Profile document associated with the staff and they do not already have an active study assignment (for the study).

Research Organization User Changes

Research Organization Administrators can apply the following changes to users within their Research Organization:

• Change User Type (internal/external)
• Edit Username
• Edit Login Method
• Edit Federated ID

Note: The option to edit Username, Login Method, and Federated ID applies only to Enterprise SiteVaults.

Cascading Name Change

When a user changes their name in SiteVault (either through VeevaID or directly in SiteVault), the changes are also reflected in their user record and study team assignments.

Site Viewer Download Options

Users assigned the Site Viewer system role can no longer download document source files but can still download viewable renditions.

Study Assignment Changes on Inactive Users

This enhancement prevents users from activating study assignments associated with inactive user accounts.

Enhancements to Study Components and Tools

Dashboards and Reports Refresh

Reports and Dashboards are refreshed with aligned terminology and appearance, and obsolete Reports and Report Types are removed.

Lao Language Locale

This feature adds the Lao language locale to the list of available languages for document and patient records in SiteVault.

Browser Tab Refreshes with User Navigation

When working in multiple browser tabs, list data will automatically update as users navigate between browser tabs, reducing the need to refresh the data manually. Also, browser tab titles display a more detailed description of the current page.

Study Export Adopts Study eBinder Folder Structure

When a study export is run, the output is presented in the Study eBinder folder structure.

Connected Study Icon on Study Details, Study eBinder, and the Studies List

This feature adds the Connected Study icon to Study Details, Study eBinder, and the Studies list when a study is connected to another Veeva product (ex. eCOA, Site Connect, etc.).

Hyperlinks Open in New Tab

This enhancement ensures that hyperlinks included in Digital Delegation email notifications open in a new tab.

eSignature Task Role Selection

This enhancement requires users to select their role when completing eSignature tasks on documents in the Draft to Current lifecycle.

---

SiteVault eConsent

PDF-Based eConsent

PDF-based documents are added as a type of eConsent form, available to upload and edit. A PDF-specific eConsent editor allows site users to overlay question and signature elements directly onto pre-approved PDF consent files, enabling the use of unmodified IRB-approved ICFs. SiteVault legacy workflows will continue to be supported on PDF-based eConsent forms. The ability to upload and edit Word-based documents in the HTML editor remains the same.

Add Consent Streamlined Process

When adding a new consent form to a study (Study > Consent Forms > Add eConsent), users are guided through a series of questions to simplify their navigation:

1. Users select to add either a PDF- or DOCX-based form.
2. Users select a form already existing in SiteVault or choose to create a new form.
3. Users are directed to the appropriate eConsent editor to make the necessary adjustments to the form.

Start Consent Streamlined Process

When the Start Consent action is selected, SiteVault reviews the current consent status and directs the user to the likely next step. When the next step is to complete the consent process, the site user is presented with the following options for selecting the preferred Consent Method:

• In-Person using Site Device
• In-Person using Participant Device
• Remote Consent

Remote Consent Guidance

When Remote Consent is the preferred consent method, site users receive guidance to assist the participant through the process. This guidance provides site users with participant steps to gain access to the MyVeeva for Patients app and the ability to generate the necessary Activation Code.

Generate Activation Codes for All Signatories

Site users can generate an Activation Code for multiple signatories in the same step when the selected Consent Method is either In-Person using Participant Device or Remote Consent.

Template Document Version Visible on Signatures Tab

The Signatures tab now includes the Template Document column, which allows site users to easily identify the document and version used for each signature instance.

Document Date Visible on Participant Consent Forms Tab

The Participant Consent Forms tab now includes the Document Date column, allowing site users to easily identify the document date associated with the consent form.

Signatory Creation Update

When creating a participant signatory, the Date of Birth field is no longer required.