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.
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.