Vault CDMS to Clinical Operations Connection

This video provides an in-depth demonstration of the seamless, near-real-time data synchronization achieved through the connection between Veeva Vault CDMS (Clinical Data Management System) and Vault CTMS (Clinical Trial Management System). The primary purpose of this integration is to significantly accelerate clinical trial processes and eliminate the inefficiencies associated with manual or duplicate data entry across critical operational systems. The presentation highlights how this unified approach ensures data consistency from the initial study setup phase through ongoing monitoring and financial management.

The integration begins during the study setup process, where selecting the connection option ensures that any updates made in CTMS—such as changes to metadata, lifecycle statuses, or the addition of new study sites—are immediately reflected in CDMS. This immediate synchronization allows site personnel to quickly begin working with the most current information, enabling them to create new subjects and complete visit forms promptly. Conversely, as new and updated subject data is entered into Vault CDMS, it is automatically pushed back into Vault CTMS. This bidirectional flow ensures that Clinical Research Associates (CRAs) and clinical finance teams have immediate access to the necessary data within their respective workflows.

The synchronized data is leveraged extensively within CTMS for several key operational functions. CRAs benefit from up-to-the-minute enrollment dashboards and streamlined monitoring visit preparation, as all relevant subject data is apparent from a single viewpoint. Furthermore, the integration drastically simplifies the clinical finance process. Completed visits in CDMS automatically trigger the generation of payable items in CTMS based on approved fee schedules. This automation allows the clinical finance team to review and process payment requests for all sites without any manual effort required to gather transaction information, significantly improving payment cycle efficiency.

A crucial feature highlighted is the ability for CRAs to perform Source Data Verification (SDV) directly from their CTMS trip report interface. CRAs have a one-click option to review subject visit forms within CDMS, where they can collect SDV activity and log subject-level protocol deviations. Once this activity is completed and recorded in the CDMS Vault, the resulting data is instantaneously reflected back in CTMS. This immediate transfer ensures that the SDV status and deviation details are available for inclusion in the CRA’s in-progress trip report, maintaining a continuous and accurate audit trail and allowing users to focus on their core roles rather than data reconciliation.

Key Takeaways: • Elimination of Duplicate Data Entry: The core benefit of the CDMS-CTMS connection is the automatic, near-real-time transfer of critical study and subject data, which eliminates the need for users in both systems to manually input or reconcile the same information, significantly reducing human error and operational lag. • Accelerated Study Setup and Site Activation: Updates to study metadata, lifecycle statuses, and the addition of new sites in CTMS are instantly reflected in CDMS, allowing sites to begin subject enrollment and data entry much faster than traditional, disconnected systems allow. • Enhanced Clinical Monitoring Efficiency: CRAs gain a unified view of necessary data from their CTMS homepage, including subject data entered in CDMS, enabling them to move seamlessly into monitoring visits with all required information readily available. • Streamlined Source Data Verification (SDV): The integration provides a one-click pathway for CRAs to access and review subject visit forms directly in CDMS from their CTMS monitoring trip report, facilitating efficient SDV activity and the immediate logging of protocol deviations. • Instantaneous Trip Report Updates: SDV activity and protocol deviations recorded in CDMS are nearly immediately reflected in the CRA’s in-progress CTMS trip report, ensuring that monitoring documentation is current and accurate without manual data transfer delays. • Automated Clinical Financial Management: Completed visits documented in CDMS automatically trigger the generation of payable items in CTMS, based on pre-approved fee schedules, allowing the clinical finance team to generate payment requests for all sites with zero effort needed for transaction information gathering. • Improved Data Consistency and Compliance: By ensuring that study build-out and subject enrollment data are synchronized across both the data capture (CDMS) and operational management (CTMS) systems, the integration supports better data quality and a more robust, auditable compliance posture. • Focus on Role-Specific Tasks: The automation of data transfer and reconciliation allows clinical operations personnel, CRAs, and clinical finance teams to dedicate their time to high-value, role-specific tasks rather than managing data movement and verification.

Tools/Resources Mentioned:

• Vault CDMS (Clinical Data Management System)
• Vault CTMS (Clinical Trial Management System)
• Vault EDC (Electronic Data Capture)

Key Concepts:

• Source Data Verification (SDV): The process of ensuring that data recorded in the Case Report Form (CRF) or EDC matches the original source documents (e.g., patient charts). The video highlights how the integration streamlines the recording of SDV activity.
• Payable Items Generation: The automated process within CTMS where completed subject visits, as recorded in CDMS, trigger financial transactions based on pre-set site fee schedules, facilitating timely site payments.
• Clinical Research Associate (CRA): The personnel responsible for monitoring clinical trials, ensuring compliance, and verifying data quality at investigator sites. The integration provides CRAs with immediate access to subject data and SDV tools.