Veeva eISF

Study Archival

Study Archival in SiteVault

This feature introduces a study archival action to assist sites with confirming readiness, capturing key information and dates, and completing the archival process. Administrators can select the Archive Study action to initiate a series of system-managed archive readiness checks against the study’s documents and related records. Once the archive readiness checks have passed and before the archival is complete, administrators are prompted to attest to several statements regarding the archival process. Once a study is archived, the study cannot be moved to any other state. Administrators can still add newly found documents to an archived study. The Archive Study action is available on any study in the Active state.

Digital Delegation

Close Digital Delegation Log

This feature introduces the Start Delegation Log Closure action, which speeds up the process of closing out a study with Digital Delegation. When Start Delegation Log Closure is initiated, the following actions occur:

• Study team assignments/delegations for users who never fully approved (do not have a date in the Start Date field) are deleted.
• Active study team assignments/delegations are moved from Active to Make Inactive - PI Approval Needed.
• The Investigator’s End Date field is populated on the final Digital Delegation document.
• The user who initiated the log closure receives a notification when the process is complete.

When the log closure preparation is finished, a Site Administrator initiates the final Principal Investigator approval. Once approved, all users who are not Site Administrators are removed from the study.

Site Documents

Site eBinder: Approval Needed Subtab and Bulk Approval

This feature introduces the ability to approve documents in bulk from the Site eBinder. When the Approval Needed tab is selected, users with the appropriate permissions can select one or multiple documents to approve. Once the action to approve is selected, users are prompted to complete any required fields. A notification banner advises when the process is complete.

Reporting

Monitoring: Updated Dashboards and Reports

The Monitoring Dashboard enhancements focus on actionable information, such as outstanding issues and monitoring review history. Monitoring reports now include Reviewed By and Reviewed Date columns, which are automatically populated when a monitor updates a monitoring status.

User Access Reporting - Current & Historical

This feature enables Research Organization Administrators to generate reports on the system access assigned to current active users or the history of access changes for all users. The Current User Access Report includes the option to filter by Site(s), System Roles, and Add-on permissions. The User Access History Report offers filters for user type (Staff or Monitor/External) and date range. Both reports allow administrators to choose the output file format and whether or not to include Study Assignment details.

Expired and Expiring Documents Dashboard

This feature introduces the Expired and Expiring Documents Dashboard, which replaces the existing Expiring Documents Dashboard. Documents related to inactive Staff, inactive Organizations, and canceled or archived Studies are excluded from the Expired and Expiring Documents Dashboard.

Read and Understand History Report Refresh

The Read and Understand History Report has been updated with new formatting and columns, as well as the inclusion of Site Documents. The report also includes the Version Sent column to assist users with identifying which major version of the document was issued for review. This report remains accessible from a document’s Actions menu.

View Name of Inactive Users

This feature enables site users to view the name of a user who was inactivated (left the organization) after the 24R3 release. The Created By and Last Modified By fields now display the full names of inactive users. Revealing the user’s name provides helpful visibility into an inactive user’s past access and actions.

Document Types, Workflows, and Notification Enhancements

Several standard eISF tools and processes are updated with usability and productivity enhancements:

New Document Types

• Source Template (Blank)

  A template document (blank form) used for the collection of data about a study participant prior to eCRF/EDC entry.

• Investigator Brochure (IB) Summary of Changes

  Describes minor or substantial changes to an investigator brochure version, but does not result in a new investigator brochure version.

eSignature Workflow Enhancements

• Document Date

  When sending for a signature, eSignature workflows automatically complete the Document Date field on document types that use the field to represent the date of signature. Upon approval by all signatories, this field will update to the actual date of approval.

• Source Documents

  The eSignature workflow is available on Source documents except ICF Signed.

• Multiple Investigator Signatories

  eSignature workflows can accommodate multiple investigator signatories. The action to initiate an investigator signature has changed from Send for PI Signature to Send for Investigator eSignature. When signing, investigators can choose to sign as a Principal Investigator or a Subinvestigator.

Notification Enhancements

• Hyperlinks in Digital Delegation Notifications

  Digital Delegation task notification emails include hyperlinks that, when selected, navigate users to the relevant SiteVault site (multi-site users) and page to complete the associated task.

• Monitor Notifications

  With this feature, SiteVault notification emails are issued to monitors when they receive access to a study.

Enhancements to Study Components and Tools

Create Participants and Patients

This feature streamlines the creation of Participants and Patients into a single step. When creating a Participant, site users have the option to simultaneously create a Patient to associate with the Participant. If an email address is provided on the Patient record, SiteVault will review for existing records with a matching email address. The existing information will display alongside the newly entered information allowing the site user to compare and then select which set of Patient information to associate with the Participant. When the study includes eConsent, users are required to create a new or select an existing Patient to associate with the Participant record.

Tab Alerts

The Team, Monitor & Auditors, Responsibilities, and Organizations tabs display an orange dot as an alert that they may require attention. Only administrators can see and dismiss alerts. The exception is the Team tab alert, which remains visible until the needed action has been completed.

Participant and Team Column Selection

This feature enhances the user experience on the Participant and Team pages within a study. Site users can select the table columns to include the preferred set of data, display in the preferred order, and resize as needed. The selected settings are retained until additional changes are made.

Participant Tab - Participant Status

The Participant tab’s Participant Status column changes from a display field to a button where all statuses are available for selection.

Staff & Participant Button Labels

The + Assign and + Create Participants buttons are relabeled to + Add Staff and + Add Participant on the Team and Participant tabs, respectively.

Veeva Mobile Applications

Vault Mobile App Site Selector

SiteVault users using the Vault Mobile App can toggle between sites using the Site Selector dropdown field at the top center of the app screen.

Aligned Regions between SiteVault and MyVeeva for Patients

This feature enhances the connection between SiteVault and MyVeeva for Patients to ensure the alignment of geographic settings maintained within each application.

Veeva eConsent

eConsent Multi-Signature Enhancements

When editing eConsent forms, site users can specify a Second Guardian and/or Second Caregiver on signature and question blocks. This enhancement facilitates gathering unique responses from each Guardian or Caregiver. Sites can assign any number of Guardians, Caregivers, and Witnesses to a Participant. When Start Consent is initiated, a maximum of two of the Participant’s Guardians, Caregivers, or Witnesses can be selected per role. eConsent forms created before the 24R3 release that include a Guardian signature will require a Second Guardian Signature block added post-release if two Guardian signatures are required.