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.
Studies with UW/FHCC Epic billing occurring after May 2023 will be required to be submitted for backload by 12/31/2022. Please contact CTMS@fredhutch.org for questions or additional information.
How do I submit a study for backload?
Study backload submissions may occur in one of two ways:
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.
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.