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Introduction

What is OnCore?

OnCore is a software product developed by Forte Research Systems and is being deployed as the UAB 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 future integration with other enterprise-wide systems such as IRAP or Greenphire. 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.

Why did UAB implement OnCore?

In 2005, UAB implemented a system called SiteMinder to facilitate billing compliance and to manage studies with UAB clinical billables (activities billed by the UAB Health System (MSO and PFS.) While this system served us well, it was no longer supported by its developer (Oracle). The implementation of OnCore across the institution in 2017/2018 enables us to not only manage our UAB clinical billable activities, but also other important components of clinical trials including participant visits and study financials.

Is OnCore new to UAB?

No. OnCore was first introduced at UAB in 2010 when it was implemented at the O’Neal Comprehensive Cancer Center (CCC). The system has been in use within the Center for Clinical & Translational Science (CCTS) in 2014 to help manage the clinical services they provide.

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 early 2019 OnCore is used 40% of universities with CTSAs and 73% of NCI-Designated Cancer Centers across the US.

What studies are required to use OnCore?

Currently, all studies that were previously managed in SiteMinder are expected to be entered into OnCore. Unlike SiteMinder, however, all study visits and all activities, not just ones pertaining to clinical billables, will be built into the protocol calendar. 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.

Can trials be entered that do not have billables?

Trials without clinical billables may not be entered into OnCore at this time as that is outside the scope of the initial implementation. The expansion of OnCore to include these trials will be addressed in the future.

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 see the below link.

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Access

How do I obtain access to OnCore?

Access to OnCore will be established following the completion of a few steps: obtaining the appropriate log-in factors from HSIS; completing appropriate training; submissions 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.

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Must I complete any training classes?

Yes. Training covers three topics: Protocols, Calendars, and Subjects. Depending on your role, one, two, or all three sessions are required. Your supervisor will determine what role you will be assigned to. For further questions about training and its 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 but requires use of an RSA token. Instructions for obtaining a token are located on the website’s Resources tab 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. If you are locked out of the system, please contact HSIS Help Desk: 205-934-8888.

Functionality

What is important about using the Financials module of OnCore?

Financials houses the study’s budget including all non-patient visit study-related items. These study-related items include, but are not limited to, start-up fees, contractual events like SAE and screen-failure reimbursements, annual IRB report preparation, monitor visits, and holdback amounts. When study visits are kept or when certain contractual milestones have occurred, study teams will have the ability to create an invoice for these items and submit them to the Sponsor for payment.

Used in conjunction with the Standard Fee Schedule, the Financials module will increase consistency in not only enabling study teams to better understand their actual costs but also recouping those costs from the Sponsors by invoicing them for standard trial-related activities.

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 location on the OnCore website under the Resource tab under Protocol Startup.

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Are there any core functions of OnCore that are currently not available for use?

Yes. Currently we are not planning to enable the use of Registries or Biospecimen Management by the institution at large.

Can there be more than one Principal Investigator associated with a study in OnCore?

No. There cannot be more than one PI listed for a protocol. There may, however, be more than one sub-investigator listed.

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.

Can data be extracted from OnCore?

Yes. Research administrative data needed for analysis can be exported in SAS or Excel formats. Researchers can use standard reports that exist within OnCore, and they can use its search tool for ad-hoc reporting. Searches can be saved and rerun quickly. Custom reports can be developed by the OnCore Report Writer and saved within the system for future use. Data can be extracted directly from the back-end database by the OnCore Technical Administrator.

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."

Will UAB discontinue the use of REDCap because of the implementation of OnCore?

No. REDCap, which is a browser-based, metadata-driven Electronic Data Capture (EDC) software solution for designing clinical and translational research databases, has many applications in research and will continue to be available.

Who do I contact for customer support?

HSIS Help Desk: 205-934-8888 or This email address is being protected from spambots. You need JavaScript enabled to view it..

OnCore and PowerTrials

What is PowerTrials?

PowerTrials integrates 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 is embedded in the EHR, thus all clinicians have awareness of their patients’ research participation via an “on study” flag. Streamline research processes - PowerTrials integrates with core EHR features so you can ensure accurate and efficient research visits.

What are PowerPlans?

PowerPlans are a group of specific orders. 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 enrollment 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. Once the trial is built as a PowerPlan, participants can be registered; trial information can be made available; and research PowerPlans can be developed. As patients are registered to trials in OnCore, the registration will flow into PowerTrials and their charts will be updated to reflect their participation as well as provide clinicians the research summary.

How is PowerTrials currently being utilized?

Since 2018, PowerTrials’ PowerPlans have been implemented and utilized for areas throughout UAB, on both the Cancer 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 Study” response in the banner bar.