Software used by Texas IRB handles entire process
iMedRIS incorporates management, data collection
(Editor’s note: This issue of IRB Advisor features the third installment of a special series on IRB software and how it is being used to improve quality and make the jobs of IRBs easier and better organized. This article profiles iMedRIS by iMedRIS Data Corp. of Yucaipa, CA.)
One of the challenges facing Texas Tech Medical Center several years ago was to start a clinical trials office that covered four academic health center campuses, located long distances from one another. "We had identified that we would have to have some way to try and communicate from the business side with the clinical trials office here," says Stacey Pugh, RN, BSN, CCRC, director of clinical services in the clinical trials office of Texas Tech Medical Center in Lubbock.
"We made attempts at developing internal clinical trials software, but we didn’t have the expertise to take it to the next level," she recalls. "We started on a quest, and we have searched out and talked with every clinical research system or software system that’s out there for the past two years."
Then last year, Pugh met with representatives from iMedRIS Data Corp. of Yucaipa, CA. "When we looked at their study assistance software and were looking at it from the patient management side, we thought their study assistance was far superior," she reports. "We knew we had to have an IRB component, so we began to speak with them about purchasing a separate IRB software package and whether they could provide that tie."
Creating a communications link between a medical software package and an IRB is a major challenge, but iMedRIS agreed to undertake the project. "We met with iMedRIS a few times and communicated by telephone; and the next thing we knew they were providing us with a product that allowed us to go to an electronic, virtual IRB," Pugh says. "That completely addressed our compliance program and systems program."
The iMedRIS product marries the site management piece with the IRB agenda, and the latest version also includes a financial module for tracking grant proposals, says William Schroeder of iMedRIS, which stands for Internet Medical Research Information Systems.
Cooperation resulted in efficiency
Pugh says the result of the cooperation between Texas Tech and iMedRIS has been an IRB software system that is efficient and integrates every aspect of research management — from compliance to data collection. The application has these features:
• Site assistant: This provides the ability to manage all aspects of clinical studies, including patient data, study information, visit tracking, screening, etc., and incorporates data from individual clinical visits.
• IRB assistant: Site activities are directly integrated with the IRB. Meeting agendas are built from requests to the IRB, and this in turn results in automatic records attendance, voting results, and meeting minutes. Any meeting outcome is sent electronically to study coordinators, and all pre-meeting study information is available to IRB members.
• Contract assistant: Negotiations between an institution and sponsor are recorded throughout the process.
• Compliance assistant: Study audits are performed, and the software ensures compliance.
"We have found that, by developing the software with Texas Tech, that this is a software that’s available for multiple sites with everything flowing automatically right to the agenda for the central IRB," Schroeder says.
Integrating a new software system is not easy, but the cost and effort can be worthwhile, Pugh says. "It has been a real struggle for us to get to this point, but we just made a light-year transformation here," she says. "A year ago, if someone had said, How many human subjects do you have on any protocol now?’ I would say, I don’t know,’ and I’d have to pick up the phone and ask the principal investigator how many people were on the protocol." Now, if Pugh is asked to obtain the same information, she could ask them to hold a minute while she pulls up the report on the computer. "It’d take me all of 25 seconds to requisition that information," she says.
The financial investment was considerable, but it was money well spent, Pugh says. "It addresses so many of our problems in one fell swoop. How do we know whether we have a system oversight without an electronic system that ties in like this one does?"
Timeliness of IRB approvals and notifications is one area that is being dramatically improved, she adds. "We’ve had subjects approved that we don’t know about for 11 months," Pugh says. "If it’s a standard risk-moderate profile and they want to bring it back for annual review, they don’t know how many subjects they’ve put on for 11 months."
Previously, investigators could be late in reporting serious adverse events (SAEs), and it would be difficult for the IRB to learn that this was a problem. Investigators now submit SAEs electronically as soon as they occur. The IRB has real-time data of what is going on, and the compliance officer can do audits with current information, Pugh says.
Also, the electronic documentation system leaves PIs no excuse for failing to amend the protocol as they go along. For instance, they should note how many people have withdrawn from a study each time the tally changes, and doing so is a great deal simpler than when the IRB relied on a paper documentation system, Pugh says. Before, there was no way for the IRB to track current enrollment numbers, and an IRB coordinator’s time might have been wasted doing an audit on a particular protocol, only to discover that only a few subjects remained enrolled.
"Ongoing protocols are being fed into the system as we speak," Pugh says. "Investigators cannot submit any information on current protocols unless everything is current and up to date. So an investigator can’t ask the IRB to review anything unless the study is established and there is current data on all subjects."
Eventually, the efficiencies produced by the use of the electronic management system would enable the IRB to reduce staffing demands, but this is not the institution’s goal, Pugh says. "We’re not looking to cut the IRB budget, but we’re looking at ways to improve staff function with faster turnaround," Pugh says.
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