Special series: IRB Software for the Millennium

Pro IRB may be convenient system for mid-sized IRBs

IRB coordinators discuss pros and cons

(Editor’s note: In this issue of IRB Advisor is the second 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 month, we are profiling Pro IRB by ProIRB Plus Inc. of St. Petersburg, FL. Look in future issues for profiles of iMedRIS by iMedRIS Data Corp. of Yucaipa, CA, and IRB Navigator sold by West Beach Software of Santa Barbara, CA.)

Pro IRB is a Microsoft Access-based IRB software application that some mid-sized and smaller IRBs have found convenient and efficient in assisting with day-to-day operations. One of its timesaving features is its ability to automatically generate letters to investigators, says Kay Beauvois, CIM, IRB coordinator for Bayfront Medical Center IRB in St. Petersburg, FL. "It keeps a tickler of all of your letters; you can pull up a program, and it will pull out your renewals every month so you don’t have to search for them," she reports.

Beauvois began to learn the software program in August 2000, when she was hired as a coordinator, and it took her about three months to become proficient. ProIRB Plus Inc. of St. Petersburg, FL, installed the software for the IRB, and an administrative assistant manually loaded all of the protocols. "But they don’t do it that way anymore," Beauvois says. "They wrote a program to convert all the data into the software program, and that’s much easier." Likewise, ProIRB regularly sends software updates through e-mail links to a web site where the improvements can be downloaded.

Another advantage to Pro IRB is that it’s affordable for small and mid-sized IRBs, notes Paula A. Bistak, RN, MS, IRB coordinator for Newark (NJ) Beth Israel Medical Center of Newark. As a part of the Saint Barnabus Health Care System in Livingston, NJ, the Newark Beth Israel IRB is separate from IRBs at the system’s three other hospitals. However, the health system was able to obtain a discount by having all four IRBs purchase the Pro IRB system, Bistak says.

"We saw the need for better tracking the history of our protocols," she explains. "And because we are a health care system and our offices are one person per IRB office, we thought it’d be nice to have a backup person who knew how to go into our database." Since all four IRBs use the same software system, any of the four IRB coordinators could fill in for one another in the case of an emergency, Bistak says.

Beauvois and Bistak outline the pros and cons of the Pro IRB software system:

• Benefits.

ProIRB Plus provides hands-on training for staff. The four IRB coordinators with the Saint Barnabus Health Care System met with a company representative for half a day to learn how to use the software, Bistak says. "We downloaded the software through e-mail, and that’s how we get all of our updates," she reports. "It’s very easy."

Beauvois finds that the software is a great timesaver, although she jokes that an IRB coordinator shouldn’t tell the boss that since they’d assign more work. "What makes the software more efficient is that you load protocol information one time, and when you do your minutes, agenda, and correspondence letters, it loads all that data for you," she says. "We have 80-100 studies a month that are open, and the software is cost-effective," Beauvois adds. "It saves you so much time in typing, and it keeps things so much more organized than a Word document."

Once the protocol information is loaded into the software program, the IRB coordinator simply has to pull up the information, click on the desired category, and the letter or document desired would appear on the screen with all of the protocol information already included, she explains. "You’re able to run any type of string search on one word, such as a search by the investigator’s name, the drug’s name, the serious adverse events (SAE) of an event, and you can run any kind of report," Beauvois says. The software makes auditing and checking for trends a breeze, she adds. Reports can be pulled on all studies that are open for a specific period of time as well as using other criteria.

Bistak says she likes the way the study information only has to be typed in once and then every time a scheduled meeting or documentation deadline comes up, the software will make it easy to update and print out a report, using the information already in the system. For example, if Bistak wants to review all of the SAEs studies up for renewal have had in the past year, the software system will easily pull up this information and list it chronologically.

The software program offers some flexibility for a particular IRB coordinator’s preferred style, Beauvois says. "You have the ability to set up your letters however you want to, to any type of template if you’re not comfortable with the standard format."

• Drawbacks.

However, learning how to use the program’s flexibility takes time. One of Bistak’s concerns is that she hasn’t been able to manipulate the program’s letter-writing format according to the style she likes, so she exported it to a Microsoft Word file to adjust the letter style. "I can’t change fonts or the style unless I save it to a Word file," she explains, adding that she has had the same difficulty in manipulating the IRB meeting minutes on the Pro IRB software. "If we do something during our meeting that is not centered around a study, but I’d like to include it in our minutes — that’s not always easy to do," Bistak says. "I’m having trouble getting used to its style."

Another concern Bistak, who has been using the software since late 2001, has about Pro IRB is that she has not been able to pull up lists of studies that are grouped in a way that is preferable to her. "I can’t manipulate it to what our system is used to." However, ProIRB Plus has been very responsive to her concerns and has makes constant adjustments, including several updates in the past four months, Bistak says. "They do listen to you and have changed some things around in response to people who are using their software, but it is not a perfect item."

ProIRB Plus asks for feedback from its customers and often will make improvements and changes according to what they say, Beauvois says. If Beauvois had a wish list for improving the software, she would like it to enable more formatting features, such as permitting bold type and underlining words. "It doesn’t have that capability right now, but it is formatted for the future to do that," she says.

(Editor’s note: For more information about Pro IRB software, contact ProIRB Plus Inc., 6020 44th Ave. N., St. Petersburg, FL 33709; e-mail: info@proirb.com; web site: www.proirb.com.)