The University of Washington is implementing new reporting requirements for clinical trials subject to the UW Diversity in Clinical Trials (DCT) policy. These changes support compliance with Washington State’s Diversity in Clinical Trials law (RCW 69.78) and aim to improve the completeness and quality of enrollment data for underrepresented populations.

Key Details:

• Applies to new clinical trials subject to the UW DCT policy that are submitted to HSD on or after January 1, 2026.
• Enrollment data must be reported using OnCore, UW’s Clinical Trial Management System (CTMS).
• Clinical trials reporting solely for compliance with the UW DCT policy have reduced reporting requirements.
• Clinical trials that are already required to report in OnCore (e.g., oncology studies, studies with UW Medicine billable activities) should adhere to those more robust reporting requirements. For these study teams, no additional training will be required under the DCT pathway.

Compliance Monitoring:

• Enrollment data, or an indication that no enrollments occurred, must be entered at least annually.
• CTMS will run monthly reports to identify studies overdue for data entry.
• Study teams not meeting these reporting requirements will be referred to HSD for follow-up.

Upcoming Webinars:

To support onboarding, the CTMS Program Office will host informational webinars on:

• November 3, 2025- 1:00-2:00 PM PT- Register
• December 12, 2025- 12:00-1:00 PM PT- Register
• January 14, 2026- 9:00-10:00 AM PT- Register

For questions contact CTMS@fredhutch.org or hsdinfo@uw.edu.