Automation sorts out AEs that need no reporting

California IRB uses electronic IRB system to help coordinators determine when reports are unnecessary

IRBs wrestling with mounting numbers of adverse event (AE) reports have been encouraged to get a handle on which items need to be reported and which don't. But often, that choice isn't only up to the IRBs — study coordinators will submit items even when they're told they don't have to.

That's the problem faced by research compliance officials at Cedars-Sinai Medical Center in Los Angeles, CA, a few years ago.

"The number of adverse event reports we were getting just continued to increase exponentially, to a point where, if it continued on that track, would really be unmanageable," says Keren Dunn, CIP, manager of post-approval monitoring and quality improvement. "Even the way it was going, it was draining a lot of resources."

Many of the reports were for offsite events in multisite trials, and didn't meet the definition of unanticipated problems involving risks to subjects or others — those that require reporting under the federal regulations, say Dunn and Eifaang Li, DVM, MPH, CIP, Cedars-Sinai's director of research compliance and quality improvement.

But Li and Dunn say attempts to convince study coordinators not to submit the unnecessary external AEs went nowhere. Coordinators told them that their clinical research organizations (CROs) required the reports.

"CROs want to make sure that everything is documented," Li says. "We'd try to advise our study coordinators that a particular external AE really didn't need to be submitted and they would immediately push back, saying, 'Our CRO requires us to do that.'"

In checking with other institutions, Dunn and Li say they learned that some IRBs simply reject the unnecessary AEs and return them to the investigators.

"And apparently that has worked for some institutions," Dunn says. "But we wanted to approach it from a way that would make things easier on research coordinators and allow them to meet the pressures and requirements of their sponsors while still reducing the burden on (the institution)."

So they employed technology, adding an external AE reporting process to the institution's existing electronic IRB system. The person submitting the AE answers a series of questions intended to determine whether it needs to be reported to the IRB.

Reports that don't meet the requirements of the federal regulations are stored in the system but aren't reviewed. The submitter gets a document from the institution saying that the event was determined to be not reportable — and so he or she has proof to show the CRO that the AE was submitted.

Less burden

Li and Dunn say the new process has lessened the burden on both study coordinators, on the IRB chairpeople who reviewed the events and on the adverse event analyst.

"Because of this automatic triaging system, now our AE analyst is handling reports that are more meaningful — the reports that really require some kind of assessment," Li says. "In the past, most of the time they were pushing paper."

The improved process has also led to shorter review times, both women say.

The electronic form asks the investigator pertinent questions about an external adverse event: Was the AE unanticipated? Does it suggest a greater risk of harm to subjects or others? Is there a reasonable relationship between the AE and the study?

"We built those very basic questions into our decision tree," Li says. "And we certainly provide a lot of help text to help people make the best decisions when they answer those questions."

Those external AEs that meet the criteria for a possible unanticipated problem involving risks to subjects or others are reviewed by the analyst and then by an IRB member.

For external AEs that are not reportable, Dunn says a letter is generated that makes it clear that it wasn't reviewed by the IRB and won't necessarily be considered as part of the IRB's continuing review of the study.

"We say that it was determined automatically by the system to be not reportable according to our policies and regulations," she says.

Dunn says the records from these non-reportable AEs are maintained in the system. The institution has audited the records to ensure that the electronic reporting system is working properly, but does not routinely examine them.

Fewer reports seen

Ironically, Dunn and Li say, giving coordinators an outlet to submit these external AEs may be leading them to submit fewer of them. In 2008 and 2009, the office averaged about 1,700 AE reports (with some reports representing more than one event). In 2010, after the system was put in place, that number dropped to about 1,000 AEs.

"What we are finding from research coordinators is that once they have done this a few times, they may feel more comfortable that they know how the decision is made and what questions they need to look at," Dunn says. "So they're more comfortable not reporting them."

The office has used automation to handle other similar tasks, such as recording changes in study staff, Dunn says.

"If they're adding a staff person and taking one off, and they're someone who is not obtaining consent from subjects and is not an actual investigator, they can make that change now and get an automatic acknowledgement of that change without going through review," she says. "Whereas, it used to require an amendment to be submitted by the PI, to be reviewed by an analyst and by an IRB member, it's now an automated process to do that."

Li says there's been some consideration of using the automated AE reporting process for internal AEs, "but we're not there yet."

Dunn says a key to the success of this approach was talking to those who would be affected by the change before deciding on a course of action.

"We always look to our researchers and research coordinators to learn how they do their jobs and see how we can help or at least not make things harder for them," she says. "I think getting feedback from the research community is important."