What Is OnCore?

Clinical Trials Management System

The OnCore Enterprise Research system, or OnCore, is a vendor-supported Clinical Trials Management System (CTMS) available at Washington University School of Medicine (WUSM). Created by Advarra (formerly Forte), OnCore is used by 100+ universities and institutions nationwide. OnCore was originally implemented at WUSM in 2015 to support the Siteman Cancer Center's (SCC) extensive reporting requirements and research operations, and is supported by a collaborative team from the Center for Clinical Studies (CCS) and SCC. In Fall 2019, WUSM began expanding OnCore access to non-oncology clinical trials at WUSM, allowing us to more fully leverage features in both OnCore and Epic to improve clinical trials management processes, including the financial management of studies (budgeting and sponsor invoicing) and to help manage research billing compliance.

OnCore Functionality

Protocol Tracking

Tracking clinical trials in OnCore keeps all protocol information in one central location and facilitates institutional, departmental, and PI-level reporting. Protocol details include the study's title, NCT number, phase, accrual goals, sponsor and funding sources, IND/IDE information, financial account number, associated staff, and many additional options, as briefly shown in the image below. IRB reviews are documented and up-to-date protocols and consent forms are stored within OnCore. Integration with the myIRB system allows select information pertaining to local IRB reviews to be updated automatically (e.g., review reason and type, action, and approval date). Study visit calendars can be created to track completion of subject visits and procedures; this data can then be used to generate sponsor invoices when the study's budget details are also entered into OnCore.

OnCore uses a library system for protocol tracking and standardized study meta-data collection based on trial type. WUSM utilizes two libraries to group for the different types of clinical trials at our institution: Oncology and Non-Oncology. Each library has customizable fields that can be defined based on unique tracking and reporting requirements for that trial grouping. For example, the Oncology library is tailored to capture standardized data for SCC's many reporting needs, including NCI grant progress reports, Data Table 4, and CTRP accrual reporting. Libraries also allow user notifications and task lists to be tailored to the group's users' needs.

SCC utilizes additional OnCore functionality to manage submissions to the Protocol Review and Monitoring Committee (PRMC), which is required for all Oncology protocols. In addition, the oncology-related Quality Assurance and Safety Monitoring Committee (QASMC) tracks their study audits in OnCore. For the enterprise-wide expansion, we will also explore the use of OnCore to facilitate the Human Research Quality Assurance Program (HRQA) program activities.

Subject Tracking

OnCore allows research teams to track subject details as needed for their specific trial, including but not limited to:

Tracking summary (bulk) subject accruals only (e.g., documenting the total number of subjects accrued within a specific time frame, as for retrospective chart review studies with limited NCI reporting requirements);
Tracking basic subject demographic data only for screen fails and enrollments (i.e., documenting only basic subject information for annual reports, etc., when there is no billing compliance risk or other need to track specific visit details in OnCore);
Full subject tracking including demographic details, enrollment and study status (e.g., "Consented," "On Treatment," "On Follow-Up"), and visit and procedure completion, as shown in the sample subject calendar below. The protocol calendar is applied to each consented subject for a personalized, auto-generated subject calendar of planned visits based on treatment assignment and subject status dates. In addition, OnCore provides an eCRF tool for investigator-initiated trials, allowing form-level data to be tracked in the system.

If your study contains a billing compliance risk, protocol calendars can be used to track patient invoiceables (i.e., research-related or SOC clinical procedures) for sponsor invoicing. SAEs can also be tracked in the system for the purposes of internal documentation and sponsor invoicing. Because protocol versions and subject participation statuses are tracked together in the same system, OnCore provides a mechanism to flag subjects when reconsent is required due to IRB approval of an amended consent form.

Integrations

OnCore is integrated with several systems at WUSM to facilitate efficient research operations, including protocol and subject tracking. Various system integrations are detailed below.

Epic

Patient Demographics

Patient demographic data is sent from Epic to OnCore in real time so that patients from WUSM and BJC can be identified in OnCore and selected for clinical trials registration. Integration across the two systems ensures that when data is updated in Epic, such as an address change or a DOB correction, the patient demographic data in OnCore is automatically updated.

Clinical Trial Protocols and Subjects

In the other direction, clinical trial protocol and subject status information is sent from OnCore to Epic. If an OnCore study requires or has an RSH record in Epic, it should be linked across the two applications. Once the study is open to accrual and is linked, patient registrations (e.g., date of consent) will be automatically sent from OnCore to Epic. Subsequent changes to subject statuses in OnCore (e.g., treatment status) will also be automatically sent to Epic and the Epic patient LAR record updated.

Billing Grids

Billing grids (study-related relative time points with associated Charge Master events) can also be sent from OnCore to Epic to assist with charge review and billing of patients on research trials.

myIRB

For studies that receive full review at HRPO (i.e., HRPO is the IRB of record for the study), data from myIRB including study review type and reason, approval date, expiration date, etc., is automatically updated in OnCore once the HRPO number is entered into the protocol details page, as described in the above Protocol Tracking section. In addition, protocol and informed consent attachments are sent from myIRB to OnCore. For studies that rely on an external IRB review, the HRPO administrative or "Request to Rely" review details are automatically obtained, and study teams can document the external review details in OnCore to help ensure regulatory compliance.

Workday

Human Capital Management (HCM)

OnCore integrates with WUSM's HR system - Workday HCM. WUSM employees can utilize their WUSTL Key for login, and access is automatically disabled for employees who have left the institution.

Finance

OnCore integrates with WUSM's Workday Finance system. Invoices created in OnCore will be sent to Workday. Payments applied to invoices in Workday will be applied to invoices in OnCore.

Billing Matrix

Subject Demographics & Statuses

Subject demographic data, and study enrollment and status information, is sent from OnCore to Billing Matrix on a nightly basis, including details such as Epic MRN, date of consent, and changes to treatment status. The integration minimizes the need for redundant data entry into the Billing Matrix system, which is required for billing compliance purposes.

Financials for Sponsored Trials

OnCore contains a Financials Console for the management of pre- & post-award clinical trial financial activities. Financial coordinators can set budget parameters (as shown in the image below) for details such as the study's rate base for charge master events, indirect withholding amounts, and rules for invoicing screen failures and SAEs, as agreed upon in the CTA. Predetermined costs can be programmed for milestone events such as consents, enrollments, cycle/visit completions, and SAEs to allow efficient invoicing after the event is logged by the research team.

As subject data is entered (anything from basic accrual information up to visit check-ins and verification of actual procedures completed), invoiceable items are generated for inclusion on future invoices. Once invoices are generated, sponsor or funder payments can be entered into and reconciled within the system, and outstanding balances determined.

Accounts Receivable + Accounts Payable Financial Data

As of July 2021, OnCore integrates with the WorkDay system. The CCS is planning future custom report development to integrate Accounts Receivable data in OnCore with Accounts Payable data from WorkDay.

Research Staff Effort

Research staff can log their daily work hours within OnCore, indicating time spent on specific protocols, as well as adding details of tasks completed. Within a protocol, effort can be associated with different stages of the protocol life-cycle, different categories of activities, and tasks within those categories. Once effort has been logged by various staff members, reports are available to show how many hours have been logged to each protocol, providing a more detailed picture of what tasks are being performed for that study. Information tracked can be analyzed for contract negotiations or to simply billing sponsors for coordinator effort.

Reporting

OnCore's robust Protocol and Subject Search tools allow users to query the database on multiple parameters, as shown in the first image below, and to extract data to fit almost all user needs. Based on the role and level of access, users can generate reports on the clinical trials and subjects they manage. In addition, OnCore has numerous standard reports available, as shown in the second image below. Custom reports can be created if study teams have any additional reporting needs that cannot be fulfilled through Protocol and Subject Searches or standard reports.

eCRFs

Electronic case report forms (eCRFs) can be created and used within OnCore, as shown in the image below, similar to the RedCap system. Data can be exported in SAS or Excel formatted files. Please note that the OnCore eCRF tool does not currently provide functionality for the creation of surveys or bulk data upload, so may not be the best option for all study needs.

In addition, OnCore's Data Management (DM) & Biostats Consoles allow tracking of form status and completion, as well as data extraction.

Subject Payments

As part of our enterprise-wide rollout, WUSM will also support use of Advarra's Participant Payments system, or Payments, which allows researchers to pay automated stipends immediately upon a participant's completion of a study visit. Payments also provides mechanisms to track payment amounts across subjects and protocols with a variety of reports, including 1099s, itemized receipts and sponsor invoicing, to meet financial and tax reporting needs. For more information, see https://clinicalstudies.wustl.edu/payment/.

Security & Access

OnCore is a secure, SSL-enabled, web-based CTMS. HIPAA-compliant and with audit support, access is password-protected and scoped to the user based on a hierarchy of access roles and the user's protocol staff assignment, management group and department association, and institutional affiliation. Access to the system is only provided after HIPAA training verification and completion of role-based OnCore training managed by the OnCore Support Team (OST). WUSM employees use their WUSTL Key for login, supported by the HRMS site integration. While external research staff collaborating on multi-institutional studies can access our OnCore system, external users can only view subjects at their site for the trials on which they are assigned as protocol staff by a WUSM regulatory coordinator.

Support

OnCore Support Team (OST)

As mentioned above, OnCore is supported by a collaborative team from the CCS and SCC, with additional assistance provided by WU Information Technology (WU-IT). OST support activities include:

Phone, email, web-based, and in-person application support;
A centralized, authoritative repository of knowledge, information, and work instructions to help users find information quickly;
Instructor-led and online training via Learn@Work;
Study calendar modeling (based on clinical trial financials, with focus on patient invoiceables);
Custom reports and scheduled data exports;
eCRF support;
Facilitating the adoption and ongoing development of informatics infrastructure in the clinical trial domain.

Please visit the OnCore User Support Manual site to view the OnCore User Manual, FAQs/ Tip Sheets, Troubleshooting Articles, Request Forms, and a plethora of additional support documentation.

Steering Committee

In addition, the OST is guided by a Steering Committee to provide leadership and decision-making support for the enterprise-wide expansion project. Comprised of WUSM department leaders, business managers, and researchers, and co-chaired by Yi Zhang, JD, RN and Albert Lai, PhD, the committee falls under the new research IT governance structure at WUSM.

Onsemble Research Community

Advarra also facilitates a collaborative research community of OnCore adopters called Onsemble, which helps advance clinical trial operations at WUSM and other partnering institutions. Through engagement via a community portal, domain-specific listservs, and bi-annual conferences, users share their best practices for clinical trials management activities and lessons learned when implementing and extending OnCore at their institution.

Enterprise-Wide Expansion

Updates on the OnCore enterprise-wide expansion can be found on our Enterprise-wide Expansion page.