Special series: IRB software for millennium - Software can be adapted to suit small IRBs
September 1, 2002
Software can be adapted to suit small IRBs
IRB coordinator likes its tech support
For small- and medium-sized IRBs that cannot afford to purchase Internet-based IRB software or to develop their own software documentation system, there is an alternative that provides some flexibility and can be adapted to suit their needs. The answer for the IRB at Oakwood Healthcare System of Dearborn, MI, is IRB Navigator, sold by West Beach Software of Santa Barbara, CA. IRB Navigator is a database and document management system for administration and support of IRBs.
"The cost is reasonable for us, and it helps us manage our IRB effectively," says Mary Barnhart, CIM, CIP, IRB coordinator for the small community hospital in Dearborn. "The software handles agendas, letters, follows board members, follows investigators, and you can adapt it to your particular facility," she says. "The company helps you design it for your particular facility."
Among the software’s features that Barnhart has found useful is its ability to call up studies that need to be renewed. "The software can do agendas and letters to investigators," Barnhart says. By automatically following an IRB’s protocol deadlines, the program will easily show with a search which studies are outstanding and which are nearing their deadline dates. "At the bottom of the screen, there is a button that says Check deadlines,’ and all you do is click the button and bring up all of your studies," Barnhart explains. "It may say you have two that have expired, three near expiration for annual review, and two studies that have missed deadlines."
After clicking on another button, the software will pull up a "Dear Investigator" letter that notifies the researcher that the study is nearing expiration and needs to be reviewed, she adds. The program stores and recalls the protocol’s study name, dates, meeting dates, other data. "It drops the letter, you print it out, have the chair sign it, and then send it," Barnhart explains. "You don’t have to type each letter individually, although there are templates you can use, and you can adjust the letters any time you want."
Since the program is user-friendly and easy to adapt to a particular IRB’s style and needs, it has the necessary flexibility to change as an IRB changes policies and procedures. Among its features are the ability to generate reports on serious adverse events, continuing reviews, initial studies, memorandums, and revisions, Barnhart says. "It will pull information from the database and put the report together for you," Barnhart says. "You also can export the information into Excel and use Excel to make a chart with that information."
Barnhart uses the program in this way when she compiles annual statistics to compare the IRB’s activity on a graph chart. Another advantage to IRB Navigator has been timely technical support and periodic updates that can be downloaded without a loss of any existing data, Barnhart says. In a nutshell, the software’s services for IRBs include the following:
• It tracks protocol information and helps an IRB prepare for regulatory audits.
• Paperwork is automated, saving clerical time.
• It uses a point-and-click system that is easy to learn and use.
• When installed, the software is customized to the IRB’s particular needs with regard to correspondence, reports, and other features.
• Letters are automatically prepared for signature and IRB communications are standardized, complying with all regulations, policies, and procedures.
• Protocol information is tracked and stored, and review dates and approval dates are recorded, as are any problems that occur with a study.
• Notices of continuing reviews, reports of activities, adverse events, and other items are prepared and ready to be sent to appropriate parties.
For more information about IRB Navigator, contact West Beach Software, P.O. Box 6009, Santa Barbara, CA 93160; Telephone: (805) 692-0089; web site: www.wbeachsoftware.com or e-mail: [email protected].
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