Automate Tasks for CRAs and Study Managers with Vault CTMS

This video provides a demonstration of how Veeva Vault CTMS (Clinical Trial Management System) leverages the Vault platform to automate routine, manual tasks for Clinical Research Associates (CRAs) and study managers. The core objective of these automation features is to significantly reduce monitoring effort and associated costs by simplifying cross-functional processes and ensuring that site and trial statuses are accurately updated based on designated completed milestones. The presentation systematically walks through key areas of the clinical trial lifecycle—site setup, monitoring, and site closeout—to illustrate how the system systematically moves work streams forward with minimal manual intervention.

During the initial site setup phase, Vault CTMS streamlines the management of the study team roster. The system allows CRAs and study managers to quickly add principal investigators (PIs) to a site. A crucial automation feature is triggered immediately upon this addition: any existing documentation associated with that PI, which has already been collected within the system, is automatically pulled into the site’s list of documents and filed in the appropriate location within the Trial Master File (TMF) structure. This ensures immediate documentation compliance and reduces the administrative burden of manual filing and cross-referencing.

The video then shifts focus to the monitoring and closeout phases, highlighting automation within the closeout visit trip report process. When completing the closeout trip report, a dedicated section allows the monitoring team to document any newly identified protocol deviations. As these deviations are logged, the user designates them as either "major deviations" or "minor deviations." This designation triggers a critical automated workflow: upon saving the report, the deviation is automatically escalated, and notifications are sent to the appropriate stakeholders, such as the study manager assigned to the trial. These notifications include a quick link, ensuring the study manager always has the most up-to-date information regarding major protocol deviations at the site, facilitating rapid response and oversight.

Finally, the demonstration concludes by detailing the system-triggered actions that occur upon the formal approval of the closeout trip report. Vault CTMS performs two simultaneous, automated actions following approval. First, the system automatically creates the final trip report document and files it appropriately within the structured TMF. Second, and critical for lifecycle management, Vault CTMS automatically triggers the site to transition to the "closed phase" in its life cycle. This end-to-end automation, from roster management to final site closure, minimizes manual effort for the monitoring team while maintaining regulatory compliance and data integrity.

Key Takeaways: • Reduced Monitoring Burden: Vault CTMS is designed to automate mundane tasks, allowing CRAs and study managers to focus on critical activities rather than manual data entry and process management, ultimately reducing monitoring effort and cost. • Systematic Workflow Progression: The platform ensures that work streams move forward systematically, relying on designated completed milestones (e.g., trip report approval) to trigger subsequent actions and status updates. • Automated TMF Integration during Site Setup: When a principal investigator (PI) is added to a site roster, any previously collected documentation associated with that individual is automatically pulled and filed into the correct location within the Trial Master File (TMF) structure. • Streamlined Protocol Deviation Management: During the closeout visit trip report, users can designate new protocol deviations as "major" or "minor," which dictates the subsequent automated escalation workflow. • Automatic Escalation and Notification: Designating a deviation triggers automatic escalation and sends notifications, including a quick link to the deviation record, to relevant groups (e.g., the study manager) to ensure immediate awareness and oversight of critical issues. • Two-Part Closeout Automation: Upon approval of the closeout trip report, Vault CTMS executes two system-triggered actions: the automatic creation and appropriate filing of the trip report document within the TMF structure, and the automatic transition of the site's lifecycle status to the "closed phase." • Data Integrity and Compliance: By automating document filing and status changes based on system milestones, the platform helps ensure that documentation is consistently filed and audit trails are maintained, supporting regulatory compliance requirements. • Enhanced Visibility for Study Managers: Automated notifications regarding major protocol deviations provide study managers with immediate, actionable insights, allowing them to maintain the most up-to-date information on trial risks and site status.

Tools/Resources Mentioned:

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

Key Concepts:

• CRA (Clinical Research Associate): Professionals responsible for monitoring clinical trials, ensuring compliance with protocols, and verifying data accuracy.
• Protocol Deviation: Any change, divergence, or departure from the study design or procedures defined in the protocol. Designating them as major or minor determines the required regulatory reporting and internal escalation.
• Site Lifecycle: The progression of a clinical trial site through various phases, such as startup, active monitoring, and closeout. Automated status changes ensure accurate tracking and reporting.