The University of Washington Human Subjects Division (HSD) is implementing new reporting requirements for clinical trials subject to UW DCT policy. The new requirements support compliance with Washington State’s DCT law (RCW 69.78) and aim to improve the completeness and quality of enrollment data for clinical trial participants. To meet DCT reporting requirements, researchers will be responsible for entering clinical trial enrollment data into OnCore Clinical Trials Management System (CTMS), a web-based resource utilized by UW and Fred Hutch Cancer Center to manage clinical trials with reporting and billing compliance requirements. OnCore is managed by the CTMS Program Office.
Studies In Scope for DCT Reporting
- Research that meets the definition of a clinical trial, AND
- UW employees or agents are responsible for or engaged in recruitment or consent activities, AND
- New study submitted for UW HSD review on or after January 1, 2026.
NOTE: There are some exceptions to UW DCT policy requirements. Please visit the Policy – Diversity in Clinical Trials section of UW HSD’s Diversity in Clinical Trials page for more information. For questions, please reach out to hsdinfo@uw.edu.
OnCore Protocol Record and Minimum Footprint Requirements
Study teams will need to establish a protocol record in OnCore CTMS and maintain a Minimum Footprint of study information and participant enrollment data for studies in-scope for DCT Reporting. A DCT Minimum Footprint of data entry is being established per policy requirements, administrative needs and CTMS system functionality. The DCT Minimum Footprint will apply to protocols in-scope for DCT Reporting, but out of scope other established OnCore Minimum Footprints.
NOTE: UW clinical trials in scope for the DCT Policy that are Oncology-related, have UW Medicine billable activities and/or require Epic activation for orders or subject tracking purposes will continue to follow Full Minimum Footprint requirements. These established requirements already incorporate data collection needs for the DCT policy; no additional data entry will be required.
DCT Minimum Footprint: Jan. 1, 2026 Implementation
Webinars, training resources and support desk assistance will be available for study teams managing DCT Minimum Footprint protocols new to OnCore CTMS.
NOTE: No additional OnCore access, training or data entry is needed for protocols following current Full Minimum Footprint requirements.
DCT Reporting – Intro to OnCore CTMS Webinar Sessions
Informational webinars for study staff managing DCT Minimum Footprint protocols will be held monthly from Nov. 2025 – Jan. 2026. Each webinar will cover an overview of DCT Minimum Footprint requirements, how to access and navigate OnCore, submitting new protocols for OnCore intake and DCT protocol staff training and resources. Scheduled webinar sessions and registration links are available below:
- Nov. 3, 2025 – 1:00 – 2:00 PM PT
- Dec. 11, 2025 – 12:00 – 1:00 PM PT
- Jan. 14, 2026 – 9:00 – 10:00 AM PT
CTMS Online Office Hours
The CTMS Program Office Online Offices Hours are available for drop-in support and guidance on a biweekly basis. Attendees will be taken to a private breakout room and CTMS Support Desk Staff will be available to answer questions, assist with new study submissions, OnCore training, data entry and more. Office Hours Zoom link is available on the OnCore landing page (active users only) or by emailing CTMS@fredhutch.org.
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- Tuesdays – 10:00 AM – 12:00 PM PT
- Fridays – 12:00 – 2:00 PM PT
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CTMS Training & Resources for DCT Protocols
~ Coming Soon ~
Just-in-time eLearning modules will be assigned to new staff members requesting access to OnCore for the management of DCT Minimum Footprint Protocols. All assigned eLearning Modules will be completed in ITHS TREE. Completion of assigned modules is required for access. It is recommended to request OnCore access when your first protocol requiring DCT Reporting is submitted for OnCore intake.
DCT Minimum Footprint Reference Document and DCT Data Entry Work Instructions will be available for guidance on navigating OnCore CTMS and performing required data entry activities. All resource documents and video recordings are housed on the CTMS Documents & Videos website, accessible to active OnCore users.
Other Information
Please check back for updates and announcements.