(Editor’s note: In this issue of IRB Advisor is the final 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 issue includes stories on PRAMS, developed by Penn State University in University Park, PA, and IRB Navigator, sold by West Beach Software of Santa Barbara, CA. Previous issues have featured profiles of IRBWISE, designed by Georgia Tech in Atlanta, ProIRB by ProIRB Plus Inc. of St. Petersburg, FL, and iMedRIS by iMedRIS Data Corp. of Yucaipa, CA.)
e-Documentation system cuts most paperwork
PRAMS saves on staff and time
Penn State University of University Park, PA, began to develop a web-based electronic documentation system in response to recent growth spurts at the same time that the university needed to keep staff growth relatively stable. "We needed to find a way to use our resources more efficiently, and that prompted us to look at electronic data systems," says Candice Yekel, director of research protection at Penn State. "Our hope is that this will ensure that not only will we have an efficient system within the administration, but that we can provide electronic data to investigators who are submitting and provide more efficiency within the review process," she explains.
The university’s IRB stands to benefit a great deal from the university’s homegrown electronic documentation system, which is called Protocol Review and Approval Management Systems (PRAMS). PRAMS development began on March 1, 2001, says Kenneth Forstmeier, director of the office of research information systems. "We spent five or six months on development and design specifications and understanding user needs," Forstmeier recalls. "The information technology shop wasn’t at all familiar with the regulatory compliance environment, so we had to understand their particular needs and how we could meet them."
By March 1, 2002, PRAMS was rolled out in its first phase. The integrated, web-based system will be more fully implemented in 2003. Other institutions will have an opportunity to purchase and use PRAMS, which is being marketed by ERA Software Systems of Monterey Park, CA, Yekel says.
"The application we developed is not only for the human side of things, but for all protocol types used at Penn State," Forstmeier says. "So we had to bring in data from five different regulatory systems and bring these into the new applications."
Yekel and Forstmeier offer these details about how PRAMS will work once it’s fully implemented:
• Eliminate most paperwork. The paperless system will eliminate the need to send paper documents to IRB members, who simply will log onto the system and see protocols ready to review, Forstmeier says. "Eventually all of it will be stored electronically — all records — and any documentation that comes in," Forstmeier adds. "We’ll receive paper from time to time, and those records will be scanned into the system and indexed and placed in a nonvolatile storage where it will be available for audit in the future."
While developing PRAMS, IRB members were contacted to see how they would feel about receiving electronic communication from the institution, Yekel says. "We anticipated that very few would want to stick with a paper system, and there were only two or three people from the four boards who wanted to continue to review by paper, and they were senior citizens who didn’t feel comfortable with computers," Yekel explains.
• Protocols may be submitted and reviewed electronically. This year, the system’s focus is making the continuing review process electronic. There are up to 3,000 protocols that the university tracks at any time, and the Hershey Medical Center, which is within the Penn State system, also has 2,500 protocols to track, Yekel says. "It’s a very large system. We have staff spending most of the day monitoring the continuing-review process, sending out notifications, termination letters, and archiving records," Yekel says.
With PRAMS, the computer will search the protocol database for expiration dates, find e-mail addresses for investigators who have studies that are about to expire, and send them a notice via e-mail along with a form they’ll need to complete, Yekel says. "When the expiration date arrives and nothing has been received or entered in our system, PRAMS will prepare a report that says the following protocols are set to be inactivated," she adds. "It’s just a matter of pushing a button. We see this as a big plus in making sure we’re not missing deadlines."
Faculty, students, and investigators are notified that the research process soon will be fully electronic, and they are asked to keep the university updated on their e-mail addresses. If they don’t use an e-mail address, they will have to let officials know, Yekel says.
In the event an IRB notice is returned undelivered from an e-mail address, or if the investigator doesn’t have e-mail access, PRAMS can print a copy of the continuing review notice for mailing, Forstmeier says. During PRAMS’ final phase in 2003, principal investigators also will be able to submit their protocols electronically. "In that case, we’ll build a wizard that will allow the principal investigator to fill out the form and answer only the questions pertinent to his or her research," Forstmeier says. "We’ll do a distribution of protocols electronically," Forstmeier adds. "And the other thing the system does do is audit all transactions, so as things change, we know who made the change, when, and so on."
This way, the system keeps track of what went wrong in the event something doesn’t work, and the electronic data can be used to figure out which areas of business processes need to be bolstered with more resources and changes, Forstmeier says. "Additionally, I think IRB minutes and agendas will be generated electronically," he adds.
• IRB and research training and other data will be electronically tracked. PRAMS will track adverse events and whether investigators and IRB members have had the required training and when the training expires. For instance, when an IRB coordinator decides to assign an IRB member a particular protocol to review, the system will show whether that member has the requisite training to follow that study. The same list of training credentials will appear with the principal investigator’s name, and this information can be updated when people receive new training or continuing education credits, Forstmeier says. The system will load data into the protocol application, rather than having someone reload the entire protocol with the updated information, he adds.
With more than 9,000 faculty, staff, and students conducting research at Penn State, this electronic ability to track their training will save the university significant time and money over the years, Yekel says. It equates to one staff person in the office spending half of his or her time checking e-mail, notifying people electronically, and verifying recipients’ addresses. With the system, that will all happen electronically, she says.
• PRAMS will cover all research and regulatory information. Another unique feature of PRAMS is that it will cover all human subjects research, as well as all research involving biohazard materials, animal use, regulatory changes under the Health Insurance Portability and Accountability Act, and conflict-of-interest issues, Yekel says. "This system is built to integrate all of those areas," Yekel says. "We keep data on animal-use protocols and biosafety information. What’s neat about the system is if I have a human subjects protocol that involves some pathogen, then this system will alert me to that issue."
The system also will provide continuous documentation from a study’s in vitro and animal trials, following the study as it moves into the arena of human subjects research.
If an IRB member or coordinator would like to learn more about a particular investigator who has not conducted human subjects research before, but will soon start, then it would be easy with PRAMS to call up that investigator’s name and learn about all of the investigator’s animal research, use of biohazardous materials, training, and funding, Yekel says.
For more information about PRAMS, contact ERA Software Systems of Monterey Park, CA, 1255 Corporate Center Drive, Suite 305, Monterey Park, CA 91754; Telephone: (323) 980-4900; e-mail: [email protected]. Also, Penn State research protection and information officials will speak on the topic of paperless IRB review at the annual IRB conference sponsored by Public Responsibility in Medicine & Research and Applied Research Ethics National Association, both of Boston. The PRIM&R/ARENA IRB Conference will be held Nov. 18-19, 2002, in San Diego.
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