Will the Billing Matrix stay or go with OnCore expansion?

Current use of the Billing Matrix system varies by department. Many functions currently used by some departments will transition to the OnCore system across all departments.

How do I register a patient who is not in EPIC?

If the patient should be in EPIC, follow the standard registration procedure for EPIC. If the study subject does not have an EPIC patient record and is not expected to need a patient record for study participation, the OnCore Support Team offers a manual patient registration process.
There are two manual patient registration forms to choose from:

  • External Patient Registration Form (External/Secondary Sites Only)
  • Manual Patient Registration Form (WashU Only): Only use this form for new study participants who do not exist in OnCore and do not require a patient record in Epic (e.g., healthy volunteer in an observational study).

Note that the majority of individuals already have EPIC records (including Volunteer for Health participants).

What does the minimum footprint design look like?

The minimum footprint is currently being designed by a large representative group of the research community. The design is largely driven by identified output needs. Individual departments and research areas may expand the minimum footprint to meet their specific needs.

Can I hide fields or add fields as needed to a specific protocol?

The roles assigned to staff will determine which consoles are available to see and enter information. Standard system fields cannot be hidden. However, there are ways to add additional data capture fields using forms or certain consoles (e.g., documenting additional reviews/approvals under Other External Committee Reviews).

What are the sprint timelines?

OnCore implementation will take place in three sprints.

Can I use payments without being in OnCore?

University policies around use of the Payments system are still being developed. The integration of OnCore and Payments increases data consistency across University systems and reduces data entry workload as well as manual entry mistakes. Our consultant’s recommendation is to utilize the OnCore-Payments integration for all protocols and subjects.

What studies will be required to be in OnCore?

Any studies requiring PRMC reviews have to go through OnCore. For PRMC guidelines, please see the PRMC website. For studies that do not require PRMC reviews, the system scope is still under consideration and as soon as guidelines are finalized, information will be distributed.

Can you describe the roles OnCore has?

OnCore utilizes three types of roles: Access, Protocol Staff, and Subject Staff.

  • Access Roles represent a group of OnCore users who perform similar tasks, and defines the permissions appropriate to the group. Roles are used for security, defining which parts of OnCore (consoles, reports, etc.) a user can access and what actions the user can take.
  • Protocol Staff Roles refer to the staff member’s role on the protocol. Available roles include Sub-Investigator, Primary and Secondary Clinical Coordinators, Data Coordinators, etc. System notifications are often sent to a specific protocol staff role rather than to a named individual.
  • Subject Staff Roles refer to the staff member’s role specific to an individual subject. Available roles include Treating Physician, Registering Coordinator, etc. Subject Staff Roles are beneficial for assigning a coverage proxy when a member of a study’s care team is out on leave.

Who assigns the roles?

Access roles are defined by the individual’s job and what they need to do in the system. The OnCore Support Team assists with proper system access and training. Protocol and Subject Staff roles are assigned by the study team.

Are only new studies going into OnCore? Nothing retroactive?

Correct. The enterprise expansion of the OnCore system will be gradual as new studies are on-boarded at WUSM. The transition of the WUSM research portfolio to OnCore is dependent upon protocol lifecycles.

Who pays for eCRF building/design and OnCore?

eCRF use guidelines are being developed. It is likely that a subset of studies (e.g., IITs with an FDA application) will have the cost of eCRF design and build covered by the institution while other study types will be offered eCRF design and build as a charge back service. Study teams wishing to do their own eCRF design and build will have the option to use REDCap.