CTMS Reporting Demo

This video provides an in-depth demonstration of the reporting and dashboard capabilities inherent within Veeva Vault CTMS (Clinical Trial Management System). The main purpose is to showcase how users can leverage the powerful and flexible reporting tools to analyze CTMS data, gain real-time views of study progress, and identify actionable insights for further activity. The demonstration emphasizes that, like other Vault applications, CTMS reporting is designed to be intuitive, allowing users to move seamlessly from high-level dashboard metrics to the underlying data records.

The presentation details how reporting views are tailored to specific user roles within clinical operations. For a Site Monitor (CRA) focus, dashboards aggregate monitoring activities and progress across all assigned studies and sites into a single viewpoint. This allows CRAs to quickly identify the status of trip reports, track outstanding comments or issues, and flag sites that fall into predefined risk thresholds. The perspective then shifts to the Study Manager, who utilizes similar data but focuses on tracking the activity of their assigned CRAs. Study Manager dashboards provide metrics on the average time required for site monitors to complete tasks, identify missing or overdue monitoring events, and track compliance broken down to an individual CRA level.

Beyond monitoring activity, the reporting functionality supports comprehensive study management metrics, including timelines, enrollment status, and overall risk. Vault CTMS allows managers to track milestone completion and enrollment progress, potentially against defined thresholds, for single or multiple studies simultaneously. A key architectural advantage highlighted is the seamless integration of Vault CTMS with other clinical Vault applications, enabling a holistic view of study health. This includes capturing metrics around TMF (Trial Master File) document tracking against expected documents, integrating subject enrollment status, and tracking milestones across all clinical applications turned on (such as Site Start-Up or SSU). The final segment details the user-friendly configuration features, emphasizing that users with appropriate access can utilize point-and-click configuration to generate personalized reports and dashboards, using any record or field (including newly configured items) as filters or columns.

Key Takeaways: • Role-Specific Operational Insights: Vault CTMS reporting provides distinct dashboards tailored to operational roles, such as Site Monitors (CRAs) focusing on trip report status and site risk thresholds, and Study Managers focusing on CRA task completion times and compliance rates. • Real-Time Risk Identification: Dashboards are crucial for identifying sites that cross predefined risk thresholds, enabling proactive intervention by study managers to maintain study integrity and adherence to protocol. • Integrated Clinical Data View: Because Vault CTMS is not a siloed system, it allows for comprehensive study metrics by integrating data across the entire clinical Vault ecosystem, including TMF document tracking against expected documents and milestone tracking across SSU and other applications. • Monitoring Compliance and Efficiency: Study managers can utilize reporting to assess the efficiency of their monitoring staff by tracking metrics like the average time required for CRAs to complete tasks and identifying patterns of missing or overdue monitoring events, facilitating resource optimization. • Actionable Data Drill-Down: The reporting structure allows users to drill down from high-level dashboard metrics directly into the underlying detailed report, which includes links to the source data records, enabling immediate action such as adjusting milestone timelines. • User-Driven Customization: Reports and dashboards are highly customizable using a point-and-click configuration interface, allowing users to easily select any available record or field (including custom fields created during or after implementation) to generate metrics relevant to their specific job function. • Automated Notification and Distribution: Reports can be scheduled to run automatically, acting as notifications delivered directly to a user's email inbox, ensuring timely alerts regarding critical study metrics or compliance issues. • Comprehensive Study Milestone Tracking: The system tracks milestone completion and enrollment status, allowing study managers to compare actual progress against established timelines and enrollment thresholds across single or multiple studies. • Data Export Flexibility: All generated reports and dashboards are exportable into various formats, facilitating external sharing, archival, or further analysis outside the Vault environment.

Tools/Resources Mentioned:

• Veeva Vault CTMS (Clinical Trial Management System)
• Veeva Vault TMF (Trial Master File)
• Veeva Vault SSU (Site Start-Up)
• Veeva Vault (General application platform)

Key Concepts:

• CTMS Reporting: The process of generating analytical views and metrics from clinical trial management data, focusing on operational efficiency, site performance, and regulatory compliance.
• Risk Thresholds: Predefined criteria within the system that, if met by a site or study, trigger an alert or flag, indicating elevated risk requiring immediate management attention.
• TMF Document Tracking: The ability to measure the completeness and timeliness of required documents within the Trial Master File against expected document lists, ensuring audit readiness.
• Point-and-Click Configuration: A user interface methodology that allows non-technical users to build or adjust reports and dashboards without needing to write code, maximizing user adoption and self-service BI.