Use these strategies when providing a prospective monitoring program

Communication, education are key

Research institutions might consider providing prospective monitoring when enhancing a research compliance program.

There are benefits to such an approach, including improved human subjects protection regulatory compliance and the long-term cost savings of a preventive approach, experts say.

The office of research compliance at the Center for Clinical Research of University Hospitals Case Medical Center in Cleveland, OH, has developed a successful prospective monitoring program, following these strategies:

Keep monitoring visits time- and cost-effective. The Center for Clinical Research tracks the amount of time it takes for each monitoring task and has developed a mean amount of time that it takes to monitor a protocol, says Philip Cola, MA, vice president of research and technology management at the Center for Clinical Research.

"If we randomly select a protocol it takes about 15 hours to complete everything," Cola says.

If a protocol is being monitored because of a reported problem then the time spent on monitoring increases to an average of 19.5 hours, Cola says.

"It takes four hours longer per protocol when there already is an issue developed versus randomly selecting a protocol," he says. "There is very different resource utilization depending on what's already the history of that protocol."

With a two-person staff, the center's monitoring capacity is about one study per week, says Cristina Ferrazzano Yaussy, MPH, research compliance specialist with the office of research compliance at the Center for Clinical Research.

"I'm usually the lead person who does the monitoring, so I'm definitely there for every single monitoring visit," Yaussy says.

Monitors conduct a variety of pre-monitoring tasks, including contacting investigators and research coordinators to talk about the monitoring process, Yaussy says.

"We make sure the study is actively enrolling participants, and we help the research team up front," she adds. "We make sure the study chosen is appropriate, and then we choose a day and set a time for the monitoring visit."

The pre-monitoring work typically takes about 4.5 hours, Cola says.

"You have to have all of your tools ready and review the protocol with the IRB in some detail," he says. "Then you go out and schedule with the investigator and do a pre-monitoring interview."

The pre-monitoring interview involves sitting down with the research staff, including the coordinator and investigator and talking about the study, Yaussy explains.

This discussion will last 30 minutes to an hour as the monitor tells the investigator which documentation will be reviewed and which records to have readily available.

The monitoring visit takes about seven hours or an entire day for an average-sized study, Cola says.

"Even if there's a larger cohort of patients, you're randomly selecting subjects in the cohort, and that takes about seven hours," he adds.

Monitors use checklists during the visit, Yaussy says. The checklist makes the monitoring process run more smoothly, she notes.

"We look at the regulatory documentation and the regulatory binder relative to IRB submissions," Yaussy says. "If the Food and Drug Administration [FDA] is involved, we look at documentation by the FDA and sponsors."

There also is a separate checklist for the consent process, and this helps the monitors keep track of dates, Yaussy says.

The checklist was developed over time, says Carol A. Fedor, ND, RN, CCRC, clinical research manager of the office of research compliance at the Center for Clinical Research.

"We started by looking at what was publicly available at research programs across the country," Fedor says. "Then we streamlined and individualized it so it'd make sense for the type of research we conducted here."

The key is for the checklist to have information that meets the goals of the research program, as well as meets the standards of accreditation, Fedor says.

Finally, the post-monitoring time adds an additional eight hours on average for the study that has been flagged due to problems.

"This is writing up a plan, communicating with the investigator, asking for clarification, looking at grants and contract issues, checking with the investigational pharmacy if it's a drug study," Cola explains. "Then you start a plan for an educational session."

Add an educational component. Monitors send summary letters back to the research group and follow up these letters with education and support, Yaussy says.

"We're available to help them understand why we made the recommendations we made," she says.

"Our approach is to get out there and work with research teams and do hands-on education and monitoring, which is how we assess and evaluate the process," Yaussy says. "We go back and talk with the research team, giving them helpful hints on how to do research responsibly."

The education component was enhanced as the monitoring program evolved.

After the first year or so of conducting prospective monitoring, it became clear that while these were friendly monitoring visits, they were less helpful than they could be, Cola says.

"We left the investigator with a letter that said, 'Here are the things you're doing wrong and that you need to fix,' but it wasn't the way I wanted it to be," Cola explains. "So we added a whole new component, which is education."

Now the monitoring visit is very useful to research groups.

"We say, 'Here are things that went wrong, but here is a program specifically tailored for you and your research group,'" Cola says. "We give examples of how you might do it differently for this study and future studies, and it's amazing how well that's worked."

The volume of educational seminars also has increased dramatically since the monitoring program began.

"We went from essentially offering one education session to the research community at the academic medical center per month to 35 responsible conduct of research education sessions on this campus in three months time," Cola says.

"We've trained about 500 people on some aspect of responsible conduct, and the most experienced investigators are showing up because they're saying, 'If we do this stuff in a proactive way it saves us all time, money, and resources down the road,'" he says. "We have a staff of 25 full-time equivalents in the areas of grants, IRB, technology management, and research compliance, and these people all end up giving educational sessions."

When compliance monitors go into the field and notice that a research group is having difficulty with some process, such as the informed consent process, then they'll create for that research group an informed consent workshop, Cola says.

Cola says the education component is an essential part of compliance monitoring.

"Without the educational component attached to it, no matter how nice you are, it feels punitive," Cola says.

Include investigators and CR staff in planning educational sessions. A feedback process was begun before the monitoring program was rolled out, Fedor notes.

"We invited a representative from most of the research groups," she explains. "We met with most of the clinical research coordinators and had to work with them to sell this idea."

Research coordinators are the ones who coordinate visits for monitoring, and they're the people the monitors call if there are any issues identified during the monitoring visit, Fedor says.

"So we had focus group discussions from the beginning, talking with coordinators, giving them a brief PowerPoint presentation, and getting their feedback," Fedor says. "I don't think we could have done anything else that was more important."

These feedback sessions empowered research staff to understand the nature of the monitoring visits, and it gave the compliance staff necessary information before they made changes to the monitoring process, she adds.

Research professionals also help plan some of the compliance education.

"We sometimes have investigators and study coordinators help plan the educational sessions because they're experts in the field," Cola says. "With their expertise and our expertise it comes to life."

For example, a research nurse in the emergency medicine department might be asked to speak about the rules in that setting and the practical issues that staff face, he explains.

"So we're utilizing our research environment and training the trainer," Cola says. "We're enabling them to bring all of this to life in the world, and I think that's why we're getting such good responses to the sessions."

An open door policy also helps improve collaboration between research administration and compliance offices and research groups.

Investigators are invited to go through the grant submission with the office, for example.

Also there are open sessions in which the IRB administrator answers questions by clinical trial investigators and staff.

"I make myself available and the manager of the IRB office and I sit in a conference room and say, 'Good morning, what are your questions?'" Cola says. "Also, some of the most senior investigators have come down and answered questions other investigators have about protocols."