This page details the following topics related to the OnCore Clinical Trials Management System (CTMS):
The Clinical Trials Support Units (CTSUs) and OnCore Team have made the conscious decision to focus on new trials. After pausing to evaluate how things were going and seeking input from study teams, departments, and other key stakeholders, we have decided to target more efficient activation of new trials before migrating additional existing trials into the CTSUs and OnCore.
Informed by thoughtful feedback from many of you, we are implementing a "stabilization" period in the clinical trials transformation to clarify processes, tighten up our practices, enhance our customer service to study teams and departments, retool our training, and build more real-time experience with the OnCore system. This stabilization period is intended to allow us to better serve our research community.
The OnCore Team is working closely with study teams, departments, and CTSUs as we continue to drive improvements to clinical trials processes and future migration trial migrations. Have a question? Need at-the-elbow support while you go through a new process? End-users can schedule a one-on-one at their desks or via teleconference with the OnCore Trainers and support team if they have any questions or would benefit from any kind of assistance. Email firstname.lastname@example.org, subject "OnCore" - we're happy to help!
Information about accessing OnCore is available here.
One of the mandates of the Clinical Trials Transformation effort is the development of an enterprise-level support model for clinical trials management. Informed by faculty and staff conducting clinical trials, a new organizational model, the CTSO, is being implemented to re-engineer business processes for initiating and conducting clinical trials that were developed in partnership with study teams and experts from across campus. The model will be supported by OnCore, an enterprise Clinical Trials Management System (CTMS).
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 will help reduce duplication of effort and the possibility of erroneous data by connecting these systems and leveraging data already present.
OnCore can integrate with other systems including MiChart, which will help 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.
In December 2013, the Medical School Research Board of Directors charged the Clinical Trials Task Force to make recommendations regarding system-wide process improvements for clinical trials research, including defining actionable solutions to increase the pace, competitiveness, and success of clinical trials. One of the top recommendations was to implement an integrated clinical trials management system (CTMS). A Request for Proposal (RFP) for a CTMS was released by U-M in spring 2014 and Forte Research System’s clinical trials management system, OnCore, was evaluated to be the top candidate and recommended for selection. In order to ensure OnCore would meet the needs of the diverse research portfolio at U-M, a CTMS project team was constituted from business and technical representatives across the institution. With the assistance of Huron Consulting Group (HCG), this team conducted a Proof of Concept (POC) using a temporary, demo environment of the software. Following a thorough evaluation of the system by a diverse/representative group of over 75 U-M study team members and research support staff using live protocols, the CTMS project team presented its findings to POC executive leadership. In March of 2016, the executive leadership group unanimously approved the purchase of a full OnCore license as well as dedicated resources to support its implementation across the enterprise.
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.