Important Reminder: Study Participant Management in OnCore
What You Need to Know
Why is it important to register a participant in OnCore?
When a participant consents to a clinical trial, study teams must register them in OnCore within 24 hours. Once a participant is consented in OnCore, they are linked to that clinical trial in APeX. This enables automated generation of a timeline, mapping out each visit with corresponding date ranges, and billing designations, ensuring charges are routed correctly.
Why must participant status be updated in OnCore?
Participant status must be updated as they move through the study. The lifecycle of a research participant in OnCore statuses is below.
As participants progress through a clinical trial, their status needs to be updated in OnCore in real time. This supports:
- Compliant Clinical Research Billing
Participant statuses in OnCore must be kept current to indicate whether a participant is active on a study or no longer associated. These statuses feed into APeX, and drive whether study-related charges (billed to insurance or the sponsor) are routed to the UCSF Research Revenue Cycle Team for review based on the Coverage Analysis. Outdated statuses can trigger unnecessary reviews, creating delays, wasted effort, and billing errors. - Accrual Tracking
The “On Study” status is critical. The “On Study” status signifies that a participant has been officially accrued on the clinical trial. Accrual metrics are used to assess recruitment performance and determine whether a study should remain open or be considered for closure due to low enrollment. - Workflow and Workload Management
Timely and accurate protocol and participant data improves operational efficiency by:- Enabling real-time tracking of enrollment, visit schedules, and study progress
- Facilitating OnCore Financials for timely sponsor invoicing, payment reconciliation, and financial oversight
- Supporting compliance, performance, and resource reporting
- Allowing managers to assign, track, and monitor studies and tasks effectively
- For oncology studies, the Cancer Center uses the Ontario Protocol Assessment Level (OPAL) tool to measure trial complexity. OPAL assigns weights to participants based on study stage (e.g., active treatment vs. follow-up), allowing leaders to balance team workload and plan staffing needs before capacity is exceeded. The tool factors participant status into these calculations, ensuring staffing aligns with both trial complexity and participant activity.
Study Participant
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