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,
- 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.
OnCore Protocol Record and Minimum Footprint Requirements
Study teams will need to establish a protocol record in OnCore CTMS for in-scope DCT Reporting studies and maintain a Minimum Footprint of up-to-date study information and participant enrollment data. Minimum Footprints of data entry requirements are determined by the institutional policies and reporting requirements pertinent to each protocol, as well as research workflow needs for carrying out protocol activities. Please refer to the Minimum Footprint Decision Tree below for determining which Footprint applies to your protocol.
Minimum Footprint Decision Tree
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: UW clinical trials in scope of 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 OnCore data entry, access or training will be needed protocols following Full Minimum Footprint requirements.
DCT Reporting – Intro to OnCore 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. All webinars will be recorded and posted on the CTMS Documents & Videos website. Webinar meeting invites will be sent out to a listserv of UW study teams approximately 2-3 weeks prior to each session. Webinar dates include:
- Nov. 3, 2025 – 1:00 – 2:00 PM PT
- Dec. 12, 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. An Office Hours meeting Zoom Link will be provided for study teams. Online Office Hours are held:
- Tuesdays – 10:00 AM – 12:00 PM PT
- Fridays – 12:00 – 2:00 PM PT
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.