Introduction
-
What is OnCore?
OnCore is a clinical trial management system that tracks protocols and participants through the life cycle of the protocol. Study calendars are built to track the progress of participants and data from the calendars is passed to the UAB billing units after study visits. OnCore offers financial management including coverage analysis, budgeting, tracking protocol milestones, invoicing, and the recording of sponsor payments. OnCore also has extensive built-in reporting features as well as custom reporting capabilities. OnCore is beneficial for a department as it provides a single location for the management of a protocol details, subjects, study visit activities, budget information, and sponsor invoicing.
-
What does Enterprise OnCore mean?
Enterprise OnCore refers to the expanded installation of OnCore across all disease groupings. OnCore was originally developed for cancer centers in 2000, and as people recognized the value in using the system for other kinds of trials, additional functions were added to better fit the needs of non-cancer trials. As of mid-2021 OnCore is used in 45% of universities with CTSAs and 71% of NCI-Designated Cancer Centers across the US.
-
What studies are required to use OnCore?
- All clinical trials with or without clinical events billed through the UAB Health System (clinical billables)
- Clinical studies with no clinical billables can go into OnCore at the discretion of the Principal Investigator.
- All protocols with CCTS services
- Protocols that do not fit within criteria 1-3 are encouraged but not required to be entered in OnCore. It may not be beneficial to study teams to enter some studies into OnCore.
This enables study staff, financial teams, and other UAB entities to see all activities associated with participant visits and not simply billables related to CTBN creation. Downstream reporting and financial management depend on this complete set of information.
-
Will there be a cost associated with using OnCore?
Yes. A standard line item direct cost is associated for all applicable clinical trials which includes those being managed in OnCore. For details on which trials are impacted and at what cost level, please click here: UAB Industry-Funded Clinical Trials Fees - The Office of the Vice President for Research | UAB
Access
-
How do I obtain access to OnCore?
Access to OnCore will be established following the completion of a few steps: obtaining a UABMC ID username and password from HSIS if one does not currently exist; completing training; and submission of the access request form found on the OnCore website. A complete list of instructions is located on our website’s the Resource tab under OnCore Access.
-
Must I complete any training classes?
Yes. Training is a requirement before an OnCore account is created. One training session covers three topics: Protocols, Calendars (visit management), and Subjects. The user’s OnCore role will be determined by the supervisor based on the job assignment. Training sessions are more effective and relatable once the user has had experience in his/her role with the study team. To schedule training or to ask questions about training requirements email
This email address is being protected from spambots. You need JavaScript enabled to view it. . -
Can I access OnCore from clinic?
Yes. OnCore is available from anywhere on-campus with an internet connection. Off-campus access is available and uses a different URL but requires use of a soft token code (smart phone app.) Instructions for obtaining a token are located on the website’s Training OR Resources tabs under OnCore Access Guidelines.
-
How long does one have before the system automatically logs off due to inactivity?
15 minutes
-
How many failed log-in attempts is one allowed before the system locks a person out?
Three times. OnCore Administrators automatically receive a notification when a user locks themselves out and will unlock the account.
Functionality
-
Regarding the Financials Module – How will our area benefit from using OnCore Financials?
OnCore Financials is an amazing tool to capture all financial aspects of your study from open to close! It allows you to house financial documents and enter study-related and subject-related costs associated with the study. OnCore Financials also allows you to post and reconcile payments towards invoices that are created in OnCore.
If financials are entered and maintained in OnCore it will generate financial reports that can be very helpful in knowing where your study stands financially. Financial Reports can display amounts withheld if withholding applies, total amounts due and paid by sponsors, and outstanding balances and aging days of invoices.
-
Is there training for OnCore Financials?
Yes. OnCore Financials trainings are conducted separately from general OnCore training. Financials trainings are currently done virtually via Zoom. They are set up to include staff in your area, so that solutions and processes are geared towards questions and situations you may have or have already experienced. To schedule training, contact the OnCore Financial Analyst. See Support Page for contact information.
-
Is there any support for users after they are trained in OnCore Financials?
Absolutely! We highly advise and encourage users to contact our Financial Analyst who will schedule one-on-one time with staff to walk through the process from entering budgets, invoicing, entering and reconciling payments, to running financial reports to share with their study team.
-
Do all financial users have to be trained on OnCore Financials?
Yes. All staff who are responsible for financials aspects of protocols are required to complete OnCore Financials training in order to receive access to OnCore Financials.
-
What fields are required to be entered into OnCore?
There are several fields that are required due to either system or institutional requirements. This collection of required data and staff role fields is called the minimum footprint. The Minimum Footprint document is located on the OnCore website under the Resource tab.
-
Are there any core functions of OnCore that are currently not available for use?
Yes. We do not plan to enable the use of Registries or Biospecimen Management by the institution at large.
-
What Staff do I need to include in my protocol details?
Study Coordinator, Billing Contact, and Principal Investigator are required at a minimum. Contact information for these roles flow to the other systems and used by other clinicians and billing staff via PowerTrials in IMPACT and the Clinical Trial Billing Notice that is used by the Clinical Billing Office. Only one primary study coordinator and one principal investigator should be identified. Others can be identified as “Study Coordinator-Secondary” and ‘Sub-PI.”
-
Will OnCore hold my study documents?
Yes. There is a specific location for you to upload any study related materials. The maximum upload size is 25 MB per file.
-
Can data be extracted from OnCore?
Yes. Data is available from OnCore from multiple sources:
- The Protocol Search and Subject Search functions in OnCore provide OnCore Users with the ability to extract data in Excel or PDF formats. For assistance with the Protocol Search and Subject Search functionality please contact the OnCore Admins at
This email address is being protected from spambots. You need JavaScript enabled to view it. . - From the Reporting Menu in OnCore, Users have the ability to run both Standard and previously developed Custom Reports. These reports are available in both online and Excel formats. For assistance with either OnCore Standard or Custom Reports please contact
This email address is being protected from spambots. You need JavaScript enabled to view it. . - For additional data needs beyond existing reporting capabilities, a custom report request can be submitted to the OnCore Reporting Team. For assistance with the process, please email
This email address is being protected from spambots. You need JavaScript enabled to view it. .
- The Protocol Search and Subject Search functions in OnCore provide OnCore Users with the ability to extract data in Excel or PDF formats. For assistance with the Protocol Search and Subject Search functionality please contact the OnCore Admins at
-
What is the difference between a "Department" and a "Management Group?"
A "Department" defines the financial reporting area. We have aligned OnCore "Departments" with our institutional Departments within the School of Medicine such as Neurology, Medicine, Psychiatry, Surgery, etc. A "Management Group" represents the team responsible for the study. Examples of "Management Groups" include Urology, Cardiology, and Nephrology Transplant. Every protocol in OnCore is associated with one "Department" and one or more "Management Groups."
-
Who do I contact if I have a question about using OnCore?
General OnCore Support :
This email address is being protected from spambots. You need JavaScript enabled to view it. Calendar Building Support:
This email address is being protected from spambots. You need JavaScript enabled to view it. UABMC ID account, username and password issues: HSIS Help Desk: 205-934-8888 or
This email address is being protected from spambots. You need JavaScript enabled to view it. -
Where are self-help and training documents or How-To guides located?
The Resources, Training, and Calendar Services pages of this OnCore website house a variety of useful information such as minimum footprint (required fields) document; training and access instructions; the calendar submission process; and How-To training resources that cover a variety of data-entering scenarios.
OnCore and PowerTrials
-
What is PowerTrials?
PowerTrials integrate research processes into the workflow of Cerner’s electronic health record (IMPACT), ensuring that clinical research and clinical care share relevant data. Its primary goals are as follows:
- Enhance patient safety - PowerTrials are embedded in the EHR; thus all clinicians have awareness of their patients’ research participation via a “Research: On Study” notation on the PowerChart Banner Bar.
- Streamline research processes - PowerTrials integrate with core EHR features, to ensure accurate and efficient research visits.
-
What are PowerPlans?
Working within PowerTrials, PowerPlans are groups of specific orders, based on the study protocol calendar. With PowerPlans, researchers have the ability to group orders into a multi-tiered plan of care. By having study-specific PowerPlans, researchers can use IMPACT to drive the procedures and assessments for each study visit. Researchers also can link the PowerPlan to study enrolment status, to limit the use of the plan to those enrolled on the study. Finally, using the PowerPlan research account feature, your research site can delineate research charges from standard of care.
-
How do OnCore and PowerTrials relate?
Study creation begins in OnCore, our clinical trials management system. Once the information is in OnCore, the clinical trial data is sent to the PowerTrials PowerPlan team. The OnCore calendar details what should be included in one or more PowerPlans. As participants are registered to trials in OnCore, the registration will flow into PowerTrials and their charts will be updated to reflect their participation. This will provide clinicians with the Research Summary and a quick access icon on the Orders page for their specific research PowerPlan.
-
What if I’m not currently utilizing PowerTrials PowerPlan?
If you find yourself in this category, you can still benefit from PowerTrials. When patients that are linked to a study in OnCore are admitted to the hospital or receive care in one of UAB’s Emergency Departments, a notification is sent to members of the study’s IMPACT Message Center. This is usually the Principal Investigator, and sometimes also includes the Research Coordinator. This notification helps increase awareness of these events for study personnel, allowing them the opportunity to communicate with the study participants regarding these events, as well as to mitigate potential adverse effects to the participants’ research study participation.
-
How is PowerTrials currently being utilized?
Since 2018, PowerTrials PowerPlans have been implemented and utilized for areas throughout UAB, on both the Oncology and Medicine side.
-
How can I access study information in IMPACT?
To access the Research Summary in the patient’s electronic health record, click PowerTrials on the Menu tab or the “Research: On Study” response on the Banner Bar.