Here’s how an IRB uses iMedRIS software
Even in the early stages of making a transition to iMedRIS software, the IRB at the Texas Tech Medical Center in Lubbock benefited from the efficiency and consistency of the electronic management system. In fact, the IRB quickly implemented policies that required investigators to submit protocols using the new system in an effort to begin making the IRB’s documentation consistent.
"Anybody who has a human subjects protocol cannot submit it to the IRB unless they are established on our system, called iRIS, the internet research information system," says Stacey Pugh, RN, BSN, CCRC, director of clinical services at the clinical trials office of Texas Tech. "You can’t do any human subjects research unless you are established into this software, and that means you have to establish a profile with our office, so we can establish who you are and what your training is," she adds.
Once investigators and their projects are established with the electronic management system, there are a surprising number of documentation efficiencies and quality-control measures that can take place. Pugh explains how the software system integrates each step in IRB protocol management:
• Sending study protocol to the IRB: The investigator, whose profile has been reviewed by the IRB, sends a protocol through the iMedRIS system. The IRB and investigators involved with the research project may access the protocol’s one-page study profile. Then the investigator will send the IRB application directly into the system. "It automatically shows up on a computer screen of the IRB coordinator, saying, You have a request for an IRB review,’" Pugh says.
Next, the IRB coordinator reviews the document and either accepts it or denies it. If all documentation is complete and acceptable, then the coordinator will assign the project a date, and the software system will transfer the application to the IRB agenda. All of the data are automatically entered, and the coordinator doesn’t have to input any of it, she explains.
At the same time the protocol is assigned to an agenda, the coordinator may assign a primary and secondary reviewer to the case. "This can all happen within an hour," Pugh notes. "Previously, this process took weeks because nothing was sent out to members until the complete packet was done, and it took one half to one week to make assignments, set up an agenda, and set up packets to send out to everybody."
Since the protocol and research documentation now is stored and reviewed completely electronically, it’s no longer necessary to send out physical packets of information. IRB members can easily review the material through their own connections to the electronic management system.
• IRB reviews: Each time a new protocol is submitted or a change is made to an existing protocol, the system automatically lists that protocol on the agenda for a review, and the IRB coordinator is duly notified. During an IRB meeting, the IRB coordinator can show members the agenda items via a computer-screen projection. Then the coordinator can record IRB votes on the computer as the meeting proceeds.
"The IRB manager and one other person will click on the screen, record votes, approval status, and data status," Pugh says. "The software captures how every member voted on every protocol, and it’s very quick. You record the time, click on who’s in attendance, and as you review each protocol, you review the application and informed-consent documentation."
An IRB manager will assign the protocol a status of denied, approved, or need modifications at the very time the IRB decides. "If an investigator is looking on-line at the protocol and the IRB meeting is going on, then the investigator will see that status right away," Pugh says. When IRB members discuss a serious adverse event, the software system can pull up the related protocol and view a chronological summary of the study.
• Continuing reviews: The continuing review process also is simplified with the software system, Pugh says. The IRB manager does not need to send out notices that a continuing review is scheduled because the system will prompt investigators of any continuing reviews they have pending as soon as they sign onto the system, Pugh explains. If the data are current, the investigator will note the status at the prompt, and so no form is necessary prior to the review.
Likewise, the IRB will have all data readily available when the protocol is pulled for a continuing review. There will be a chronological list of amendments, dates, details, and study numbers — initially and currently. "So, if the IRB wanted to stop a study out of concerns about safety, the IRB members would know how many people now are enrolled in that study," Pugh says.
• Integration and privacy protections: An additional advantage to the iMedRIS system used by Texas Tech is that it is integrated with the health care system’s hospitals. There may be times that some data may need to be shared between the two, and this can be done more easily than in a paper-documentation system.
"We’re using all aspects of the software, including patient data, clinical data, contracts, and IRB software," Pugh says. "It’s all one system and is fully linked; but when the IRB signs on, they see the same thing that I might see, but it’s limited to the IRB component."
All four campus sites have access to the electronic system, so if there is a study that involves a clinical trial conducted on all four campuses, the IRB can look at all of the data collectively, she says. "The thing is we establish a home IRB for that; and if we’re all doing the same clinical trial, is there any need for all three to submit the same safety report?" Pugh says. "There is not, so this helps reduce the redundancy."
On the other hand, since the entire system has a strong firewall, encryption, and password requirements for access, there is no danger that the wrong people will obtain the IRB data. "The only person who has access to the actual subject’s name is the coordinator or investigator," Pugh reports. Also, only people who are designated in advance by the IRB are permitted to make changes to a protocol. "If an investigator wants to make a change, the investigator would have to go in and make an amendment for a mandatory submit that shows up as a request for review on the IRB screen."
• Storage of data: The server system is designed to have redundant systems that automatically back up data so data are never lost, she says. "We had to purchase new servers because we wanted software that is isolated on its own servers. "This system can run on Macintosh and IBM, so the only investment was to house the software itself; and we have a security system that is the same as the security system for our institutional medical records with the same level of accountability."
• Training investigators, staff: So far, the staff and investigators have been fairly positive with the change to the new system, she says. "We’ve finished training people on all four campuses at this point. We understand it’s going to be a big challenge, and we understand that because it’s a whole shift in the way of thinking, people still are very invested in the paper system."
For at least a brief period of time, the IRB will keep hard copies of approval letters and create some paper duplication of the documentation, but that will slowly be phased out. "There are small redundancies now, but it will dramatically impact our IRB paper load in the future," Pugh says.
• Ironing out kinks in system: Early on in the process of switching to the electronic system, Pugh and others identified some workflow issues. "We wanted multidepartmental access to certain studies that cross department borders and require an alteration in the firewall protection," she explains. "And they had to make a modification there."
Also, the IRB is beefing up a handful of forms to make certain they reflect the best practices. "The company has been very fast in getting changes in place, and we’ll continue to find small things as we go," Pugh says.
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