Compliance Corner: Update strategies after switch to electronic process
Update strategies after switch to electronic process
Goal was 100% transition in 2 years
Transitioning to an electronic submission process is challenging. It also is a time when IRBs need to pay close attention to current compliance practices with an eye on updating standard operating procedures to reflect the new electronic practices and processes.
"The first thing we did at UCSF after deciding to go to electronic submissions was to decide how to transition existing paper files into the electronic database," says Lisa Denney, MPH, CIP, CCRP, assistant director of the human research protection program (HRPP) at the University of California – San Francisco.
The questions to ask before beginning this change are: Do we transition existing paper studies into the electronic system or do we let those studies continue as paper files until they conclude? Do we have principal investigators continue with paper submissions, or do we have them begin with electronic submissions and manage their existing studies electronically from a starting point on?
The HRPP office opted for a full transition to electronic submissions and files with a goal of being 100% electronic within a two-year period that concludes in 2012, Denney says.
Once the paper transition process was decided, the next step was deciding how to handle the people transition process: "We had to decide how to transition IRB members from reviewing paper files to handling electronic submissions," Denney says.
The result has been a success, with about a 30% decrease in mean IRB review turnaround time, she adds.
"We were able to knock off about 30 days just because of [eliminating] the paper processing time," Denney says.
"Investigators used to have to make 18 copies when there were corrections," Denney says. "All of those mailings, paper processing and files disappeared when they could do it all on their computer."
Achieving this efficiency and success does take considerable preparation and effort. New standard operating procedures and training are needed. Denney provides these tips on improving electronic process compliance:
• Compliance Tip #1: Give investigators and staff a hard deadline and enforce it.
"We gave everyone a four-month time frame for submitting studies by paper, and we gave them a cut-off date," Denney says.
Any studies or continuing reviews after that date had to be submitted electronically, or they would not be able to move forward, she adds.
The goal was to have the system operate 100% electronically within a couple of years, she says.
"We wanted to manage all work for all studies in the electronic system with no paper copies for the IRB," Denney says.
This hard deadline prevents a long-term transition in which old studies continue to be submitted in paper format while all new ones are electronic.
"This way IRB staff and research staff do not have multiple ways of processing submissions," Denney says. "It streamlines the process."
• Compliance Tip #2: Ask for user input to improve buy-in.
"This was not an executive, authoritative decision we made from our office alone," Denney notes. "We brought together many users, principal investigators, and other people, who play many different roles in the campus, together."
Electronic technology has improved exponentially in recent years, and many investigators and other users have become familiar with sophisticated technology and applications created by companies that can afford more research and development involving user interface, Denney says.
"From a functional standpoint, the electronic IRB submission system will do what you need it to do, but it may not be as great as an Amazon-type program with much more money to put into design," she explains. "Research coordinators who use the system frequently learn the system, but people who use it for one or two studies a year find it frustrating."
The key was to introduce the system to users and ask for feedback. At the same time, managers might note the new system's advantages, such as how it will save users' time. When investigators are asked to correct something in their IRB submission, they can correct it on the computer and send it electronically. This is far faster than having to correct it on paper and then make 18 copies to send to the IRB for distribution to the board, Denney explains.
• Compliance Tip #3: Make no exceptions on transitioning to full electronic submissions.
"We have four committees of 18 board members, and we said, 'This is the way we're going to do this,' and we held our ground on it," Denney says. "We had senior managers go in with every IRB member to train them."
They also created quick guides to using the system.
"We made an executive decision that each IRB member had to work in the system this way," she says. "We had only one member out of 72 IRB members who said, 'I can't do this.'"
For that one person, they send the IRB submissions by email as a pdf file, but it's still not turned into a paper document by the IRB, she adds.
During the transition process, Denney and IRB staff met with IRB members for 20 to 90 minute meetings to go over the electronic process.
• Compliance Tip #4: Invest in thorough, continuing training.
"We have ongoing classes in the computer lab, an introduction class, and an advanced class," Denney says.
Training began before the system went live. IRB staff, clinical research coordinators, and others learned how the system works and how to manage submissions.
Training was held with each campus unit, and the HRPP office offered to hold training sessions at any site that made the request.
"Three of us trained over 1,700 people," Denney says. "All we need is an Internet connection at the site, and we can give them a demonstration and a handout on using the system."
Training was a big undertaking, and it is a continuous process, she notes.
"We have ongoing classes, outreach, and we created quick user guides with screen shots in the system," she says. "We have a phone call line where someone is available to help users."
The electronic system was integrated with existing information technology systems, and many users found it was not an easy system to learn, she says.
"We found that people wanted you to hand-walk them through it and tell them how to do it rather than to read the guide," Denney says. "This time was well-spent on our behalf, and our staff was learning the system at the same time."
As the IRB trainers became more familiar with the system, they developed into better educators and have improved on the electronic system.
"In addition to helping people, we're making a lot of business decisions," she says. "There were some things we had to do differently, and we hadn't thought through every last detail until they came across our desk."
• Compliance Tip #5: Hire someone to handle new system.
It helps to have a lead person work with the electronic product's vendor during the transition period. The same person can run reports, which is one of the chief advantages to having an electronic IRB submission system.
"We created this new job in our office," Denney says. "She wrote all the applications and got the workflow done, and now she's the lead for running reports and for being the person who investigates complicated problems."
The information expert, who ideally has experience working in an IRB or clinical research office, also can answer users' more complicated questions, she adds.
Transitioning to an electronic submission process is challenging. It also is a time when IRBs need to pay close attention to current compliance practices with an eye on updating standard operating procedures to reflect the new electronic practices and processes.Subscribe Now for Access
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