25R3 Release Notes

Cancelled monitoring events can now be restarted to enter the Planning state if cancelled in error.

New standard site-facing Study Team Roles have been added: Budgets & Contracts, Data Coordinator, Other Non-Investigator, Pharmacist, Regulatory Coordinator, and Research Nurse.

A weekly flash report is now available of all users with overdue tasks (document workflow tasks or quality issues) to ensure active TMF Management and timeliness. Users with an overdue task receive an email notification when the report is run.

Admins must now opt each study in their Clinical Vault into the RIM<>ClinOps connection by selecting “Yes” for “Connect to RIM”. All existing studies must also be updated. Newly created studies now default to “No,”" and must also be set to “Yes” if they should be included in the Connection. Our product owners will be in touch if any action is required for you.

Veeva LIMS Basics is now available for early adopters. Contact your Account Partner for more information.

Read-only users can now view in-progress content in as well as Approved documents. Additionally, a new View Non-Steady State Documents field is available in the User Access Details section on the Users Admin Tab, which grants read-only users visibility to in-progress content.

A new Country Settings tab is now available for Vault Admins that enables easy management of country-specific settings. Default Material Expiration Date sets the standard expiration timeframe for materials, and Approved with Changes Lifecycle determines whether the Approved with Changes option is enabled within the Material lifecycle for that country.

A new Approved with Changes verdict is now available during MLR Approval. This workflow option gives Approvers the ability to indicate that a material is substantively approved but requires minor edits.

You can now generate pre-clearance and post-marketing eCTD compliance packages directly from PromoMats Basics. A new tab collection, Regulatory Submissions, is now available to users with the Submission Coordinator system assignment.

In QMS, you can now qualify external sites, such as suppliers, CROs, labs, etc. as a provider of one or more materials and/or services.

A new Confidential field now drives visibility to a document. If “Yes” is selected, only admins and document control can see the document. Other users can only see the document when assigned a task or when manually added as a Viewer to the sharing settings. If Confidential is set to “No”, users can see the document in its steady state. Click “Learn More” to understand the impact. Our product owners will be in touch if any action is required for you.

Data previously named a “Product” is now named a “Material.” Materials can then be further classified into what type of material they are, enabling a broader range of materials to be captured within the system, such as APIs, intermediates, and more. All existing records have been classified with a type of “Finished Product”, however this value can be updated by Vault and Quality Admins as needed.

Document approvers now automatically receive training credit for any documents they sign off on and do not receive a training assignment.

Training is now evaluated on an hourly basis, at the half hour mark, rather than overnight. This means that if training is added to a learner’s matrix, they only need to wait a maximum of 60 minutes before it is assigned. While actively working on updates to the training matrix, it is recommended to leave records in an Initiated state so that training is not sent out before it is fully ready.

Amendments can now be requested on audits from both the Closed and Pending Finding Closure states. Similar to other processes, this amendment allows for the controlled addition of comments and attachments after the record has been approved.

A new security profile called Document Viewer is now available. Document Viewers can see all documents in the general lifecycle that are in an Approved state, and can participate in document workflows. Document Viewers are simply Document Participants that, by default, can view all Approved documents but cannot create any new documents.

Two new reports are now available to be run directly from any document in which Health Authority Question and Commitment Extraction is available. These reports allow users to see key details about those records that are associated to that specific document.

A new Retain Roles Until Workflow Completion field on workflows allows workflow owners to designate if they wish for workflow participants to retain their temporary roles on a document until either their task is completed (when set to “No”) or the entire workflow is completed (when set to “Yes”). The current behavior prior to this release is equivalent to selecting ’no'.