Vault CTMS Demo: Risk-based Study Management

This video provides an in-depth demonstration of Veeva Vault CTMS’s capabilities for Risk-Based Study Management (RBSM), illustrating a unified approach to optimizing clinical trial operations. The core purpose of the tool is to enable life sciences organizations to seamlessly identify, assess, remediate, and monitor risks across individual clinical trials and analyze trends seen across an entire study portfolio. By centralizing risk management processes, the system aims to improve data quality, reduce operational risk, and ensure resources are allocated most effectively to high-risk areas.

The process begins with the establishment of a centralized location for storing risk templates. This library can include pre-defined risk mitigation action items and categories, which form the baseline for risk assessment templates used at the study level. Multiple assessment templates can be incorporated, such as a standard Risk Assessment Template (RAFT), allowing users to pull in numerous risks from the library. When drilling into a specific risk, the system allows for setting default values, assigning examples, and defining mitigation items. Crucially, the platform provides an area to view how that specific risk has been assessed across all multiple studies that have utilized it, driving standardization and learning across the organization.

Once approved templates are established, generating a study-specific assessment is streamlined. Users can select one or multiple approved templates as a starting point, or alternatively, leverage an existing study’s completed risk assessment if the new trial is structurally similar. Within the newly generated assessment, users can easily adjust the three core risk factors—impact, probability, and detectability—to auto-calculate a precise risk score. This score is accompanied by a visual icon, making the level of risk associated with each line item immediately clear. Mitigation action items can be selected, and these actions are set to automatically generate and send out tasks to the appropriate roles listed, such as Clinical Research Associates (CRAs).

Following the completion of the assessment, it is submitted through an out-of-the-box workflow for review and approval by designated groups or individuals. Upon approval, the system automatically generates a comprehensive assessment document inclusive of all data and files it directly to the Trial Master File (TMF) side of Vault Clinical, eliminating manual filing effort. Subsequently, all mitigation action items are automatically dispatched to the relevant users' task queues. CRAs, for instance, receive site-level tasks detailing the risk, linking back to the assessment, and providing an area to track resolution details, including dates captured in the background to measure cycle times. All this collected data culminates in centralized dashboards, which provide actionable business intelligence by visualizing trends around the most difficult-to-detect, highest-impact, and highest-probability risks across the entire portfolio, allowing organizations to compare study scores and identify the riskiest trials for immediate intervention.

Key Takeaways: • Centralized Risk Library: Vault CTMS provides a single source of truth for storing risk templates, mitigation action items, and categories, ensuring consistent application of risk management standards across all clinical trials. • Flexible Assessment Generation: Studies can initiate risk assessments either by selecting from multiple approved, standardized templates (e.g., a standard RAFT) or by cloning a completed risk assessment from a structurally similar existing study, promoting efficiency. • Automated Risk Scoring: Risk scores are dynamically calculated based on user inputs for Impact, Probability, and Detectability, providing immediate visual feedback (via icons) on the severity level of each identified risk. • Workflow-Driven Approval: The system utilizes an out-of-the-box workflow for assessment review and approval, allowing users to select single or group approvers, ensuring necessary oversight before implementation. • Seamless TMF Integration: Upon final approval of the risk assessment, the system automatically generates the assessment document and files it directly into the TMF within Vault Clinical, ensuring compliance and eliminating manual documentation steps. • Automated Task Assignment: Selecting mitigation action items during the assessment phase automatically triggers the generation and distribution of tasks to the appropriate roles (e.g., CRAs), streamlining the remediation process. • Site-Level Task Management: Assigned users, such as CRAs, receive specific site-level tasks in their queue, complete with details about the risk, links to the assessment, and a dedicated area to track resolution status and completion dates. • Cycle Time Tracking: The platform tracks resolution dates in the background, capturing cycle times for risk mitigation activities, which provides valuable metrics for optimizing operational efficiency and identifying bottlenecks. • Portfolio-Level Business Intelligence: Comprehensive dashboards aggregate risk data across all studies, allowing management to view trends related to the highest impact, highest probability, and most difficult-to-detect risks across the entire portfolio. • Comparative Study Analysis: The dashboards enable users to compare risk scores between different studies, facilitating the identification of the riskiest trials that require immediate, targeted resource allocation and intervention. • Standardization and Learning: The ability to view how a specific risk has been assessed across multiple studies allows organizations to continuously refine their risk definitions, mitigation strategies, and templates based on real-world outcomes.

Tools/Resources Mentioned:

• Vault CTMS (Clinical Trial Management System)
• Vault Clinical
• TMF (Trial Master File)

Key Concepts:

• Risk-Based Study Management (RBSM): A methodology focused on proactively identifying, assessing, and controlling risks that could affect the quality and safety of clinical trial data and subjects.
• Risk Assessment Template (RAFT): A standardized document or digital template used to categorize and quantify potential risks within a clinical trial, often serving as a starting point for study-specific assessments.
• Impact, Probability, and Detectability: The three core factors used in the system to calculate a quantitative risk score, determining the severity and likelihood of a risk event occurring and the ease with which it can be identified.