Data customization possible with IRBANA
Michigan IRB using software to go paperless
]Editor’s note: In this issue of IRB Advisor is the first installment of a special series on IRB software and how institutions can use it to improve their operations. This month we profile IRBANA software, by DDOTS Inc. of Ypsilanti, MI.]
An IRB data management software system currently being rolled out at institutions across the country gives IRBs the ability to minutely tailor their own systems and to suggest their own additions.
Among the adaptable features of the web-based IRBANA (Institutional Review
Board Activity Negotiation Accountability), developed by DDOTS, Inc. of Ypsilanti, MI, is the ability for an institution to be as paperless — or not — as it wants to be, says DDOTS President Stephen Burke.
"Your [IRB] agenda can be web-cast, documents can be web-cast and shared," he says. "But in a lot of cases, people still want paper at this point.
"You can say, ’We want to be totally paperless by this date,’ but what are you going to do about Dr. Smith, who doesn’t own a computer at home, and in the office, his secretary runs it and prints out all his e-mail for him?
"What we did in the construction of IRBANA is to say you can be as paper-full’ or as paperless’ as you like," Burke says.
Trista Koehler, senior research coordinator for the Michigan Cancer Research Consortium at St. Joseph Mercy Hospital, Ann Arbor says her institution is using IRBANA in its own quest to become paperless. "We’re heading that way," she says. "We would like to, but it’s a lot of work.
A lot of people are afraid to get rid of that hard copy. It’s going to take a lot to convince the members who sit on the IRB to look at a computer screen all the time, versus receiving those big volumes of books."
Using IRBANA, an IRB can maintain a database of studies, including adverse events, revisions, and amendments. It can monitor frequency of reviews and flag studies to go to a specific IRB meeting. The software also can generate IRB agendas and create packages of web-based meeting information, which can be made available to IRB members online in a read-only format.
Documents that can be uploaded by investigators and downloaded for use by the IRB include PDFs of applications, consent documents, and HIPAA forms.
At meetings, secretaries can check off agenda items with the board’s action indicated, and IRBANA will automatically generate minutes indicating what transpired. The system also generates follow-up letters for principal investigators whose studies were acted on in the meeting.
Works with clinical trials system
The system dovetails with another DDOTS product, CREDIT (Clinical Research Environmental Data Information Tracking), a clinical trials administration and patient scheduling program. Data can be imported easily from CREDIT to IRBANA, cutting down on the burden of duplicating data input, Burke says.
"Most people who sign up for IRBANA also get CREDIT," Burke says. "In a traditional system, the IRB receives paperwork or electronic files, which need to be loaded into the system somewhere. That can mean hand-typing it in, or cutting and pasting [from one program to another]. If you have CREDIT, the CREDIT staff does that — they just throw a disc in and send all the adverse events for the meeting, revisions, continuing reviews," he says. "You click a button and it all goes into IRBANA. The IRBANA workload is hugely reduced and we’re not assigning people to do dual work."
Clients have the option of storing data onsite or taking advantage of a hosting company partnered with DDOTS. Data is encrypted, and the system is logon and password protected, with passwords expiring every 120 days. An institution can assign one of 50 levels of authorization to an individual user, depending on what access that person needs to have to the system at large.
"For example, a user may have access to read-only on protocols," Burke says. "They may have upload capability to upload documents into the IRB documents area. Or they may have read-only authorization to go and download, but they can’t delete and can’t upload new documents.
"In some cases, if you don’t have authority into an area at all, it doesn’t even appear on your screen, it’s not selectable," he says.
A running log keeps track of logons into the IRBANA system, and protocols show whether someone has viewed them or changed them in any way.
Security is just one area that is customizable to the last detail for a particular IRB.
"Customization is everything down to whether you want to call this a study or a protocol — you choose," Burke says. "You can choose the mouse-over description of what a field is [the text that appears when a cursor is placed over the field title]."
IRBANA has templates for letters and other documents, which can be customized for individual clients in any way they choose. And the software is upgraded every two weeks, Burke says, based mostly on ideas garnered from users.
Burke says that every other week, when new features are introduced, clients have the option of enabling them or not. Koehler estimates that her organization uses about 80% of the available features offered by IRBANA.
Handling multiple IRBs
She says she’s found the system to be easy to learn to use.
"It’s user-friendly, it’s not intimidating when you look at it," Koehler says. "I’ve worked in programs where you look at it and your eyes just go AAHHH! You look at this and it’s just comfortable."
She says the only part of the system she had trouble learning was the document processor. "Creating merged fields and all that can be tricky, but I think it you’re a person who’s used to doing that, it probably wouldn’t be. I wasn’t used to it, but now I am, because I do it all the time."
Koehler says she found the system especially helpful when her organization added another IRB. "When I learned we were switching to two IRBs, I was kind of panicky," she admits. "I was thinking, oh my God, I’m going to have to re-enter all this stuff, and it wasn’t hard at all."
In addition, Burke says IRBANA is multiple-IRB capable, with the ability to allow outside IRBs to work on shared protocols. It can handle commercial studies, with a financial package that allows for invoicing direct costs and receiving payments.
DDOTS licenses IRBANA for an annual fee of $7,500. Burke says there are no additional transaction fees, fees per protocol or fees per user, and there are no limitations on the number of users or protocols allowed.
If a client wants to use the hosting service, the fee is $300/month, unless the client also is a CREDIT user, in which case the service is free (the CREDIT fee is an additional $7,500 per year).
The fees include two days of onsite training, and Burke also works with the institution before installation helping to configure the system to meet the user’s needs.
"We normally have the system about 80% to 85% configured, in some cases 100% configured," Burke says. "It depends on how much time the organization and the contact person are willing to work with us online prior to the actual go-live date and training date."
Burke says that while IRBANA is designed for ease of use, it still can be a rough transition for some staff, who are not used to working on a web-based system, and may be more comfortable with their older software.
"[IRBANA] is like any database, you have to maintain it," he says. "When the meeting’s over, you have to put the information in to get the minutes. You sometimes have people who say, You know what? I’m just going to keep my minutes over in [Microsoft] Word like I always have.’ Pretty soon, people will start to lose interest in maintaining the information in IRBANA because they still have it elsewhere in our old Access database or Word. I’d say that’s the hardest thing about IRBANA — or any new software," Burke says. "To migrate staff, getting everyone on the same page. It’s a tough decision to move to a new piece of software that runs an office."
For more information about IRBANA, contact DDOTS, Inc., 4571 Ellsworth Road, Ypsilanti, MI, 48197, by phone at (734) 434-7734 or visit the company’s web site at www.ddots.com.
An IRB data management software system currently being rolled out at institutions across the country gives IRBs the ability to minutely tailor their own systems and to suggest their own additions.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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