This page details the following topics related to the OnCore Clinical Trials Management System (CTMS):
Over the past several months, many U-M groups have been collaborating to create the infrastructure to better support our clinical trial activity as part of our enterprise goal to execute a diverse portfolio of high-quality clinical trials to create the new knowledge needed to improve clinical care, value, and health outcomes. This work includes migrating currently active clinical trials into the U-M clinical trial management system, OnCore, and transitioning studies under the support of a Clinical Trials Support Unit.
We will be partnering with investigators and their teams between October 2017 and July 2018 to migrate our non-oncology clinical trial portfolio using a “rolling migration” process. These trials will migrate in weekly cohorts to allow for transparency and partnership throughout the migration. Oncology trials will begin migrating later in 2018.
Given that there are nearly 300 studies to migrate, we have developed a draft schedule (accessible via Level 1 password) of when trials are slotted for migration. This plan is preliminary. CTSO leadership will be systematically reaching out to schedule an in-person meeting at least two months in advance with each study team to verify that studies on the list meet the U-M/NIH definition of a clinical trial and are still active (i.e. study visits still occurring), discuss the process, and confirm a final migration date.
In the meantime, more information about the migration of your trial(s) is available through your CTSU Administrator listed below or contact CTSOgroup@umich.edu:
- Ambulatory & Chronic Disease (ACD): Kate Huffman
- Acute, Critical Care, Surgery & Transplant (ACCST): Barbara Munsey
- Behavior, Function, Pain (BFP): Tracey Naylor
- Children's (CHI): Tracey Naylor
- Heart, Vessel, Blood (HVB): Ann Cornicelli
- Neurosciences & Sensory (NSS): Diana Miller
Information about accessing OnCore is available here.
Informed by faculty and staff conducting clinical trials, our organization is supported by OnCore, an enterprise Clinical Trials Management System (CTMS). OnCore allows for automated standard interfaces to the Michigan Medicine’s electronic health record to other systems like MiChart and the data warehouse, reducing duplication of effort and possibility of data entry error. OnCore provides the ability to track and report on any protocol, at any stage of that protocol, including for all participants registered as well as financial metrics.
Developed by Forte Research, OnCore is a comprehensive (administrative, regulatory, financial, and clinical functions) CTMS already in use at many peer institutions.
OnCore offers a wide range of capabilities, including integration with MiChart, which helps reduce duplication of effort and the possibility of erroneous data by connecting these systems and leveraging data already present.
These integrations include receiving patient demographics from MiChart as well as sending billing information to MiChart. Integrations will be carefully leveraged to minimize overlap between systems and duplication of data entry. All trials being serviced by a CTSU will be managed in OnCore; likewise, all study teams wishing to use OnCore will do so in association with the appropriate CTSU for that study. All clinical trials will be supported by a CTSU by January 2018.
How will the OnCore implementation affect study teams and clinical trial administrative staff?
All members involved in clinical trials management will directly or indirectly be involved with the implementation and benefit from the use of OnCore. This can include entry of study information, updating protocol amendments, overseeing budget and financial status or reports of generated from onCore.
Will all data from the UM legacy systems be migrated into OnCore?
Yes, select trial data for existing active trials will migrate into OnCore in waves. The first wave of trials have been identified. Communication to PIs was sent to inform them of their trial or trials migrating into OnCore within the Wave 1 migration.
Will the legacy systems still be accessible after go live?
Studies will remain in MBECT until they are migrated into OnCore. eResearch will continue to be the source of truth for IRB information entry, which will integrate with OnCore.
What type of training will be given for OnCore?
End user training sessions will cover functions of OnCore based on the specific access given to a particular role (coordinator, financial, etc.). Tools will be provided for follow up training and additional training sessions if necessary. Individual training will also be available as needed. Post implementation, OnCore Super Users and the OnCore Core Team will provide at-the-elbow support.
How does OnCore integrate with MiChart?
OnCore has several automated interfaces to the U-M Health System’s electronic health record, MiChart, reducing duplication of effort and possibility of data entry error. The MiChart team and OnCore Implementation team are working closely to finalize the integration elements for the upcoming OnCore deployment.
What is the risk that OnCore just becomes another system that we have to enter administrative data in?
OnCore will be the central source of information for managing protocol administrative data for all clinical trials and providing information about U-M’s overall trial portfolio. OnCore can also be used for research data, if the study teams so choose. Other universities that have adopted OnCore have found value in the system not only for administrative data but also for research data.
School of Public Health is a data coordinating center (DCC). How will that work with OnCore?
If the role of UM is only the DCC, meaning UM is not a clinical site, there is no need to go through the CTSU. If UM role is DCC and also clinical site – the clinical site portion must go through CTSU if this is a clinical trial. If it is not a clinical trial, per NIH definition, it does not need to go through a CTSU. The DCC portion can go through department grants office particularly if including different PIs.
OnCore sounds like the one stop for all clinical trials at U-M. Will OnCore be available to researchers' trials that do not meet the NIH definition of a clinical trial?
At this point, we are prioritizing clinical trials and establishing best practices. PIs that want to use OnCore for clinical studies that are not clinical trials (such as registry or observational) should consult with medical directors of the CTSU most relevant to their research.
I understand OnCore has vast functionality, which of OnCore’s resources will be required for CTSUs, study teams, and staff members to use?
Use of the following tools are required: billing calendar (budget), tracking study visits, patients enrolled, and finance. OnCore offers many other functions that are optional.
Will the University phase out REDCap because of the arrival of OnCore?
No, REDCap will remain available, though OnCore will be used to manage clinical trials' administrative data.