SiteVault Release Highlights
SiteVault General
Create and Manage Staff without a User Account
With this feature, administrators can create a Staff without also giving them SiteVault access. The creation process follows the regular Staff creation steps, but when prompted to complete the Create As field, select Staff (No SiteVault Access). Administrators can also add a User Account to a Staff should they later require access.
Create and Manage Staff Access and Permissions
Administrators will enjoy a streamlined process for creating and managing access and permissions for both Staff and Monitors/External Users. These enhancements include:
- Visible confirmation of meeting email address requirements
- Required duplicate entry of email address upon user creation
- A simplified process for managing site-specific access and permissions
Additional Languages with Locales
This feature adds the following language locales to the list of available languages for document and patient records in SiteVault:
- Arabic (Israel)
- Catalan (Spain)
- English (Australia)
- German (Belgium)
- Hebrew (Israel)
- Hungarian (Hungary)
Study Team Assignments: Notes
This feature introduces a Notes section to the Study Assignment record. This section will include the Notes field, a space to share additional details regarding the user or assignment information.
Study Team Assignments: Bulk Actions
When in the Study Team Assignments section of a study, administrators can simultaneously apply an action to one or more assignments. Using checkboxes and the bulk action menu, the following actions can be applied:
- Activate assignments
- Populate the Start and End Date-Time fields
- Initiate the Delegation Acceptance workflow
Free Tools Menu
This feature introduces the Free Tools menu with links to ClinicalTrials.Veeva (CTV) and Veeva Launch Pad. CTV is a free clinical study search, and Veeva Launch Pad is a free password management tool designed to help you access sponsor systems more easily.
SiteVault eConsent
eConsent: New Fields for Verifying Consent
To assist users during consent verification activities, this feature adds the following fields to the eConsent Form Responses table:
- Document Description
- Signature Date
Additionally, eConsent countersignatures completed using SiteVault eSignature are captured as Form Responses. The new countersignature Form Response fields include:
- Site Staff
- Role
- Reason for Signing
SiteVault eISF
Study eBinder: Subtabs and Bulk Approval
This feature introduces the ability to bulk approve documents from the Study eBinder. Users can select tabs offering two additional views: Approval Needed and Approved. 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 green notification bar advises when the process is complete.
Site eBinder: Last Site Selected
When a user navigates away from the Site eBinder, this feature ensures the site selected at that time remains selected upon return.
Documents: New Doc Types, Updated Doc Details
This feature introduces four new document types and updates two existing document types.
- New Document Types:
- IP Relabeling: IP Re-labeling, IP Relabelling – Evidence of an IP relabeling event that took place at the site.
- Participant Decoding Event: Emergency Decoding Authorization, IP Treatment Decoding – To record the action of breaking the blind for an individual participant, urgently if needed, or when interim or final unblinding occurs.
- Recruitment Plan: To describe the planned participant enrollment/recruitment goals for the study, and the methods by which those goals will be tracked and achieved.
- System User Access: IRT User Account Management, IxRS Account Log –Identifies which site staff have received accounts for a third-party system (such as randomization or ePRO) used for the study. May also identify revocation of access.
- Document Types - Updated Descriptions:
- Conflict of Interest: COI Form – for NIH studies, covers the institution’s requirement to manage conflicts of interest in research. For some industry studies, may be required by Sponsor or CRO (in addition to/not a substitute for Financial Disclosure Forms).
- Feasibility Questionnaire: Feasibility Survey, Site Feasibility Form, Site Suitability Form – Evaluation of site feasibility for a potential study. Completed by site at the request of the Sponsor or CRO, or according to local regulation.
SiteVault Study Connect
Safety Distribution: Select All
This feature enhances existing Safety Distribution functionality in Study Connect. In addition to the Select All checkbox, users can also use the Select All button. The Mark as Read button now includes a document count, advising users of the amount of documents currently selected.
Device Registration Code Relabeled to Activation Code
With this change, the code to provide participants who wish to register for MyVeeva for Patients without providing an email address or phone number is the Activation Code. Previously, this was labeled as the Device Registration Code (DRC).
SiteVault
