A Clinical Trial Management System (CTMS) is an enterprise software system used to manage and track clinical research activities within an institution. This CTMS (OnCore) serves as a single, centralized, web-based resource used to manage clinical research conducted within or across Fred Hutch Cancer Center and University of Washington.
Features
OnCore CTMS provides an extensive range of functionality that will strengthen the conduct of both oncology and non-oncology clinical trials:
Clinical Research Management
OnCore serves as a centralized resource for study teams, central offices and clinic teams performing the day-to-day activities required during the conduct of clinical research. The system is used to manage study start-up and amendment activities, track regulatory approvals, provide access to study documents, track subject activities and manage study financials and billing compliance.
Billing Compliance
OnCore standardizes study billing processes, including sponsor invoicing and subject visit tracking. Study Billing Grids built in OnCore are sent to UW/Fred Hutch Epic Electronic Medical Record (EMR) system to support research billing review processes.
Integrations / Interfaces
OnCore is integrated with the UW/Fred Hutch Epic EMR and Fred Hutch Investigational Drug Service (IDS) Vestigo systems, facilitating the exchange of billing information, subject status data, patient demographics and protocol staff role assignments.
Reporting / Analytics
OnCore provides robust data and reporting functionality, streamlining the collection of data and metrics used for clinical trial start-up timelines, billing and financial operations and National Cancer Institute (NCI) reporting requirements.
Timeline
July 2018
Data migration of protocols and related subjects into OnCore, and enablement of OnCore functionality and workflows.
September 2021 to Present
Ongoing identification and optimization of data migration, workflows and compliance processes.
Why Do We Need a CTMS?
The CTMS allows partner institutions to build upon their reputation as national leaders in clinical research. It helps ensure the integrity of clinical research performed at Fred Hutch and UW by facilitating operational and fiscal compliance. The CTMS was implemented to:
- Improve the experience for patients on clinical trials
- Strengthen research study reporting
- Simplify research study billing compliance
- Improve management of research study financials
- Improve study subject management
- Improve implementation and timelines of research.
Background
The CTMS is a critical tool for improving our institutions’ clinical research process. The value is paramount not only in process best practices but also in our federal commitment to both the Fred Hutch/University of Washington Cancer Consortium Cancer Center Support Grant (CCSG) and UW Clinical and Translational Science Awards (CTSA) grants.
Previously, each institution used a collection of disparate systems, databases and document management tools for managing study subjects, regulatory compliance, reporting, study data capture, sponsor invoicing, research billing and research administration. These systems were incredibly labor intensive to maintain, and required manual inspections to ensure that documents were appropriately tracked and updated. Developing reports required a significant effort in data reconciliation to create consistent and defensible reports.
Further, Investigators and study teams are responsible for implementing and managing many aspects of their study operations. As a result, the ability to effectively manage clinical research varies across teams depending on funding and resource availability.
The implementation of the CTMS has helped to centralize, standardize and streamline many aspects of clinical research at Fred Hutch and UW Medicine.