Study Backloads

OnCore CTMS Study Backloads

Active studies with UW/FHCC Epic activities are required to transition (i.e., backload) into OnCore CTMS for financial and subject visit tracking workflows. These workflows, also know as “Target 3” or “T3,” utilize OnCore functionality to improve post award management and billing compliance. The process of backloading a study into OnCore begins with a REDCap Amendment Submission or Study Backload Survey. The process includes:

• For University of Washington (UW) Non-Oncology Studies new to OnCore:

→ The creation of an OnCore protocol record, study calendar, billing grid, budget, and the backload of study subjects.

• For Oncology & Fred Hutch (FH) Non-Oncology Studies with an existing OnCore record:

→ The creation of a study calendar, billing grid, and budget.

How do I submit a study for backload?

Study backload submissions may occur in one of two ways:

1. Study team submits a Study Backload Survey by 12/31/2022
2. An amendment is submitted for the study anytime between now and 12/31/2022
   • Unique Amendment Survey link is found in the study’s OnCore record in the PC Console > Documents/Info > FAQs tab

What are the steps for backloading a study into OnCore?

1. The study team will complete a Study Backload Survey or submit a study amendment.
2. CTMS Program Office will build an OnCore protocol record (as needed) and a study calendar.
3. UW Clinical Trials Office (CTO) will perform coding, coverage analysis transcription from existing billing grid, and pricing.
4. CTMS Program Office will enter the Budget.
   • NOTE: For UW non-oncology studies, CTMS Intake will also load current subjects, add the Initial IRB review, and connect the OnCore protocol record to Epic for protocol and subject integration.
   • The study team will review and validate protocol and subject information.
   • Following validation and connection to Epic, the study team will perform protocol updates, enter IRB reviews, upload protocol documents, and perform subject registration and subject status updates in OnCore.
5. The study team will review and sign off on the study calendar, billing grid, and budget in OnCore.
   • Following review and approval, CTMS will connect the study to Epic for billing grid integration.
   • When the budget and study calendar are finalized and released, the study team will start subject visit tracking and sponsor invoicing in OnCore.
     • NOTE: For existing OnCore records, the study team will confirm subject Treatment Arm assignment prior to visit tracking.
     • Other Epic activities will continue in Epic, including but not limited to, timeline management, encounter linking, and releasing subjects to monitors.

Please contact the CTMS Program Office at CTMS@fredhutch.org or 206-667-2868 for questions regarding study backloads.