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General

  • OnCore is a software product developed by Advarra, Inc. It is being deployed as the University of Utah (UU) and Huntsman Cancer Institute (HCI) enterprise-wide Clinical Trial Management System (CTMS). OnCore is a comprehensive web based CTMS that offers clinical trial lifecycle management, study participant and safety management, and electronic data capture and reporting through its core module. OnCore also allows for billing compliance and study budget management as well as integration with other enterprise-wide systems such Epic and ERICA.  

  • The implementation of OnCore across the institution will enabled us to not only manage our clinical billables within studies, but also to manage other important components of clinical trials. Study teams will be able to manage their participant visits and study financials in a more efficient process that maintains and improves compliance with regulations and local policies.

  • Yes. OnCore was first introduced at the UU in 2010 when it was implemented at HCI. The system has been in use to help manage the clinical services they provide. Research teams at HCI have been instrumental in assisting with the launch of the system across the institution.

  • All research involving human participants that meets one or more of the following criteria must be entered into OnCore: 

    • Any research study that includes a prospective clinical item including lab tests, blood draws or x-rays. This is the case regardless of whether the clinical item(s) will be paid for by the research project (study sponsor) or the participant’s insurance. A clinical item may include any treatment (e.g., drug, device), intervention (e.g., randomization of patient to one of two standard of care treatments), or clinical procedure (e.g., blood draw, MRI, physical exam, pathology order. All clinical services must be billed.

    • Any study that meets the definition of clinical trial by the requisite sponsoring agency (e.g. NIH), regardless of inclusion of prospective clinical items as outlined above.  

    • Any study where a participant receives any payment that meets the current University policy for remuneration (i.e., cash, check, gift certificates, gift cards, or other items of value). 

    The implementation of the OnCore system has been supported largely by the Office of the Senior VP for Health Sciences (Dr. Good). Ongoing maintenance will be supported by fees charged to studies. Initial set up and annual costs for OnCore must be incorporated into grants and contracts for industry sponsored clinical research at the present time: 

    • Federal/Foundation: $2500 start-up/$1500 annual maintenance (paid by the Colleges/Institutes using F&A funds that have been distributed to them). 

    • Industry Sponsored: $4000 start-up/$2000 annual maintenance (included in your study budget). 

  • Studies that do not meet the requirements for registration into OnCore can be entered into OnCore, but are not required. ERICA will employ an electronic process to determine which studies will be sent to OnCore once an application is created for IRB review to identify those that are required for study team.

  • uTRAC will no longer be used to track clinical research charges now that OnCore is implemented. Studies that are currently active or in a draft state have been migrated to OnCore. Studies that are exempt or closed will have data stored where it can be accessed in the future, in a view only format.

  • On April 25th, all charges reviewed & approved in Epic will be sent to the default account that is listed under the OnCore Financials Chartfield.  Our Epic IT team (Jake & Randy) will generate a report and send these over to Peoplesoft to post.   

    If charge corrections are needed for existing ePAYs please continue to use the CRCE communication system to reach Lisa Stock @ lisa.stock@hsc.utah.edu 

    For new charge corrections after April 25th, please use Epic’s In-Basket communication system to reach Lisa Stock. Since charges will post to the study account, the department will need to do an eJournal entry to send the charges back to the hospital account.   

    If the study has more than one account listed in OnCore Financials Chartfield, the default account will be used. The department will need to do an eJournal entry to route charges to the correct account for payment. 

  • Our patients and community will continue to have access to studies available at the University and HCI with a new process handled solely through ERICA. “Study Locator” will be used by the University of Utah in the future using information provided during the IRB application process. Any studies that are currently approved and would like to use that platform will need to submit an amendment. Any questions about Study Locator can be directed to Office of Research Participant Advocacy.

  • Three additional modules will be implemented with the OnCore CTMS.  

    • eREG is an electronic regulatory binder system.  

    • Participant Payments provides a process to pay/reimburse participants involved in studies and cover their cost of transportation or other out-of-pocket expenses. 

  • Our OnCore Website provides information about OnCore, eReg, Payments, SOPs, Tip Sheets, FAQs, and so much more.  

    If you have questions, need to request assistance from our team, experience an issue with any of our systems, or need to request an account you can contact us by submitting an OnCore Service Now Request.  

     

    You can email or call our team and be directed to the appropriate study team member. 

    Email: oncore-support@hsc.utah.edu

    Main Office Phone: 801.646.5925  

    Meet our team and find direct contact information at OnCore Team

Sponsors

  • So why Oncore? Why should sponsors pay for OnCore? The one piece that keeps repeating from different sites is “it’s the cost of doing compliant research at the U”. 

     

    OnCore provides multiple benefits for sponsors that conduct research at the University of Utah. These benefits include better data management, continuity of participant management, tracking of participants and study progress, and streamlines the process for audits and monitoring. These activities can streamline the process and reduce errors, need for resources and time, and cost. With these features, better data are available for sponsors to more efficiently get a product to market.  

     

    • Data Organization and Management: The system can manage study-relevant clinical data and information from different sources organized in one system. It allows studies to be more easily managed at multiple sites across our system and externally. OnCore is backed up and protected through robust and redundant systems to protect data sources.  

    • Continuity of Participant Management: Every member of the study team throughout the organization can be updated about a participant’s study status. Mechanisms are in place with the system to identify participants in multiple trials and reduce inadvertent enrollment in competing studies that could impact the outcome of a particular trial or impact participant safety. This will reduce adverse events and data that are required for reporting to federal and local agencies.  

    • Participant and Trial Tracking:  The system allows study teams to monitor studies at the participant level and study level to ensure that important milestones are met. Data can be collected more accurately, reflecting fewer protocol deviations or lost participants, improving study data outcomes for the overall trial.  

    • Audit Readiness: OnCore provides audit readiness that allows the clinical trial’s regulatory and study management documentation to be updated efficiently and timely. This will reduce human errors that are commonly present in the conduct of clinical research with an electronic system. There are audit trails provided and modules within the system are FDA 21 CFR 11 compliant.  

    • Monitoring: OnCore allows monitors to rely less on “over-the-shoulder” monitoring when confirming data. This reduces time, resources, and cost.

Fees

  • Yes. A line-item direct cost is the emerging standard to be incorporated into study budgets. This is part of a larger effort to better manage the financial performance of clinical trials. More information about these costs can be found on our OnCore Fees page.

  • Fees are in effect now for all new studies that were added to OnCore as of 05/01/22. 

  • No. Studies that were underway and had an executed contract prior to 05/01/22 will not be assessed the fees.

  • Fees are assessed at study start-up (site initiation visit) and annually, thereafter. The exact CTMS Fees can be found in the Clinical Research Institutional Fee Schedule. These fees include a one-time start-up fee and annual maintenance fees throughout the life of the study. 

  • Fees are assessed at study start-up (site initiation visit) and annually, thereafter. The exact amount to budget for CTMS Fees can be found in the Clinical Research Institutional Fee Schedule.

    • One time start-up fee 

    • Annual maintenance fee 

  • These fees are charged directly to the college or institute that is receiving F&A funds from the grant/contract. They are not charged to the department or study budget. 

  • It is necessary to assess a standard fee for all studies that require registration in OnCore. OnCore assesses their fees to the University of Utah based on the use of the system, not the size of the budget or type of study. Until we understand the full scope of these types of studies along with sponsor feedback, the fees have been set at this amount for any study using the system. 

    Please see our About OnCore page for which studies are required in OnCore.  

  • A formal waiver process for OnCore fees is being developed. Until that is available, please email the CRSO team at crso@hsc.utah.edu

Training and Access

  • There are a few steps that need to happen for you to get access to OnCore. You will need to complete OnCore Orientation and complete the assigned eLearnings on Advarra University. OnCore Orientation is offered on Thursday at 12 noon. You can sign up for the class on our website, https://ctsi.utah.edu/crso/oncore/training-resources.

    After the eLearnings and OnCore Orientation are complete submit a Service Now ticket to gain access. 

  • No. Epic access will be granted once the required epic trainings are complete. To sign up for Epic Training you can log into the LMS or call the IT Training Hotline Additional information can be found on our website under Epic Research. 

  • To fully activate your OnCore account an email will be sent to your work email that you will need to click a link to authenticate. This link does expire in 72 hours, if it is expired please submit a Service Now ticket and we will send you a new link.

  • To keep things consistent with other platforms that are used here at the university. You can access OnCore by entering your uNID, (ie uXXXXXX), Your DUO information will need to be satisfied and then you will be able to log into the system.

  • Each user will be assigned different roles wtihin OnCore. These roles will allow access to different areas within OnCore. If your coworker has different buttons/access than you. You may need additional roles assigned to you. Please submit a Service Now ticket and we will get you the additional access you need.

  • You may need to be added as a staff member to the study. Have your co0-worker who can access the study add you to the staff list. By going to Oncore>PC Console>Main>Staff>add staff. A tip sheet is available on our website for more specific steps with screenshots to add staff to a study. 

  • Yes, we do offer classes to learn about each of the different consoles within OnCore. You can sign up our specialty courses on our website. These classes are offered via Microsoft Teams virtually. If you would like to schedule a training for just your group, we are happy to accommodate those requests. Please reach out to our CRSO Training Team at crso@hsc.utah.edu

  • Yes. At OnCore Orientation you were given access to Advarra University, the LMS system that is used by the vendor who supports OnCore at the University. You can access many eLearnings on specific areas of OnCore within Advarra University, many of which are free.

    If you are not able to access the system please reach out to the CRSO office via email CRSO@hsc.utah.edu. Steps are provided on how to access Advarra University are available on our website. There are some courses that have a cost associated, these courses are not paid for, required or suggested by CRSO. There are a multitude that are free that have excellent information.

    Also, remember there are office hours that are available most days between 7-4 MST. 

  • The CRSO Training team is available to assist with all of the OnCore questions. You can book Office Hours on our website. Each appointment is 30 minutes, feel free to book appointments back-to-back, if you have many questions or we are going to be building a calendar in OnCore. Also, there are many tip sheets that can be found on the website, for both OnCore and Epic Research.

  • You can join our mailing list by going to our website and entering your email address. These emails will be sent with not only updates to the system, system down time and any other OnCore related topics, tips and tricks or upcmoing new releases.

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