Why Do We Need a CTMS?

Why Do We Need a CTMS?

The CTMS implementation will allow the partner institutions to build upon their reputation as national leaders in clinical research. The CTMS will:

  • 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.

Currently, each of the institutions, including the UW/FH Cancer Consortium, use multiple disparate systems and document management tools for study subject management, research regulatory compliance, reporting, study data capture, sponsor invoicing, research billing, and research administration. These systems are incredibly labor intensive to maintain and require manual inspections to ensure that documents are appropriately tracked and updated. Report development additionally requires a significant effort in data reconciliation to create consistent and defensible reports.

Investigators and their 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.

Our investigators have access to various data collection systems across the institutions, such as REDCap, a free open source software tool to manage their study data. These systems are not a substitute for a CTMS, and do not provide enterprise visibility across studies for reporting, budgeting, billing and monitoring.

The implementation of the CTMS will streamline and simplify many aspects of the clinical research process at Fred Hutch, Seattle Cancer Care Alliance and UW Medicine.