Buffalo Translational Consortium News

OnCore project is improving clinical research at UB in ways big and small

Posted on 07/05/17 at 12:14 pm
Rick Rejman (left), a clinical research coordinator in the CRO, works mostly on studies of kidney disease

Roll-out of the university-wide OnCore research management system continues to make progress one year after its first introduction to the UB research community. The software system is designed both to facilitate the full management of individual clinical trials and house the university’s human subjects research portfolio.

In addition to streamlining processes at labs and clinics across UB’s three campuses, the ultimate goal of the project is to get every trial involving human subjects into the same system to improve reporting at the department and university level.

As of this writing, more than 900 trials had been entered as the phased roll-out to all the schools proceeds on a department-by-department, person-by-person basis.

Good for individual labs, good for the university

“It elevates UB as a research institution,” says Kim Brunton, RN, MSN, who is associate director of operations for the University at Buffalo Clinical Research Office (CRO) and director of the Clinical Research Center. She has been a key player in the acquisition and implementation of the new OnCore system.

For coordinators managing full clinical trials, use of OnCore helps to reduce the administrative burden of organizing studies, scheduling patients, keeping up with regulatory requirements, archiving study materials and invoicing study sponsors.

“One of the biggest things that it allows us to do is to have financial reconciliation,” says Brunton. “You do the work then you get paid, rather than waiting till the end of a study to ‘catch up’ on billing.”

In addition to streamlining office procedures and improving money flow, OnCore helps principal investigators as they prepare reports, monitor patients, recruit new subjects and analyze the feasibility of future studies. At the institutional level, administrators can now gather information about the studies at UB in real time, which is a big plus when communicating with the industry sponsors and government agencies that control research funding.

Reduces the administrative burden on coordinators 

Brunton hearkens back to when she was a coordinator in the vascular surgery department and every year prepared a report for the chair on all the vascular surgery studies. Her counterparts in general surgery and transplant surgery would be putting together the same reports for their departments, and the chair would compile those reports and forward the results to the dean, who was collecting the same information from all of the other chairs.

“That can take some time and, obviously, resources, to put it together,” says Brunton. “Through the OnCore system, I can have that report -- to whatever management level is required -- in about 32 seconds. The reporting capability is huge. And it takes away some of the burden for those administrative duties that falls on individual coordinators so that they can be out there doing the things they are more suited to, like recruiting and following the patients.”

OnCore is an acronym for “Online Collaborative Research Environment.” It’s designed to break down the silos in biomedical research. It provides a means for the UB and Buffalo Translational Consortium research community “to get a look at the big picture, to keep track of what’s going on where, and make connections. … Just knowing which people are doing what is a big deal,” says Brunton.

A powerful tool for patient recruitment

Currently, it’s almost impossible to get a handle on all the clinical trials that are going on at UB with up-to-date information -- such as the enrollment of patients, for instance. Having a readily accessible database that can be searched by investigators, providers, and even patients who might be interested in participating in a study, is a boon to recruitment efforts. 

“The nice thing about OnCore is that when a study’s status changes within the system, it also changes on the public-facing website,” says Brunton.

A place for everything, everything in its place

Entering data into the OnCore system isn’t an additional task for coordinators. Rather, it consolidates under one umbrella a number of the tasks coordinators already do anyway. “When I was a coordinator I had a whole bulletin board full of spreadsheets tracking this, that and the other thing,” she says, “but now all that is done within the system, and it’s easy to get at the information you need.”

Bringing all that data together in one place can have unintended side benefits, too.

Yvonne Woolwine-Cunningham is a clinical research coordinator in the CRO who works mostly with vascular surgeons at Buffalo General Hospital. She has been using the OnCore system for almost a year.

“We used to have something called an enrollment tracking log that we’d have to put all the patient visits into, plus site monitor visits, SAEs (Serious Adverse Events) and submissions to the IRB (Internal Review Board),” she says. “We would keep the log for the people who bill the sponsors for the studies, so they know what was done and what to invoice for. We don’t have to do that anymore because all that can be pulled from OnCore.”

The NCT (National Clinical Trial) number is a unique identification code assigned to each clinical study registered on the federal government’s clinicaltrials.gov centralized database, but “it’s not something coordinators typically need or use,” says Rick Rejman, a clinical research coordinator in the CRO for the past four years. However, sometimes a coordinator does need that number, and then it can be a challenge to find it.

Rather than hunting through binders and binders of information, or searching the government website for the hard-to-find NCT number, he discovered he could pull the number up from OnCore instantly.

“I find it useful for tracking consents,” Rejman added. “It’s a good reference point to see what’s up and coming, what’s needed for patient visits, and for recording information after the visit. The calendar in itself has been a great time-saver because I can look to it and see really quickly when the next scheduled visit should be without checking the patient’s chart,” he said. The calendar automatically lays out protocol-specific scheduled visits, which is another labor-saving feature, according to Rejman.

“Sponsors love remote monitoring,” says Brunton, “but it requires site resources to copy, redact and send the information they’re going to look at. Historically, they don’t pay for that. But now that’s something we’re capturing in the system, so we can bill for it. It puts us in a position of having that knowledge and real data behind it. And knowledge is power.”

Getting started with OnCore

As with any new system, “there’s a bit of a learning curve at first,” says Woolwine-Cunningham, "but the more you use it the easier it gets. The OnCore support team has staff that come out and train you, and they’ll come out and help you with any problems. They’re really responsive.”

“It’s pretty intuitive and user-friendly,” added Rejman.

There will be extra work to do as a coordinator learns the system, and it may take awhile to get studies that began before implementation into the system, but research coordinators have found that the centralized system saves time and effort in the long run.

"OnCore is changing the way coordinators work to make the process more streamlined and effective and productive,” says Brunton. In the process, UB’s research community has gained a powerful new tool for tracking ongoing research and positioning the university to expand its overall research portfolio.