Streamlined on-line UP/SAE reporting cuts workload
Thought up front results in 'a smooth system'
A new online decision tree for reporting unanticipated problems (UPs) and serious adverse events (SAEs) has helped a research ethics office reduce unnecessary paperwork and reports and improved compliance with the institution's policies and federal regulations, an IRB compliance coordinator says.
"What caused us to go online with unanticipated problems reporting was the federal guidance from OHRP [Office for Human Research Protection] and the FDA [Food and Drug Administration], clarifying their reporting requirements," says Carolyn Mackman, MPhil, IRB compliance coordinator at the University of North Carolina at Chapel Hill in Chapel Hill, NC.
"We decided to use an online system to help investigators who had reporting requirements to understand what those were and to make sure the IRB was receiving meaningful reports," Mackman explains.
Before making the change, the IRB received numerous reports from clinical trial (CT) sites, including many that did not meet the regulatory definitions for UPs and SAEs, Mackman says.
"Once they started using the Web site portal, they realized a majority of things they were previously sending to the IRB were unreportable events," she adds. "So over time we saw a drop of submissions down to a very few reportable events."
Although the change to online reporting took place June 1, 2009, the IRB already has seen anecdotal evidence of a decrease in time spent on handling UP/SAEs and in paperwork, Mackman says.
"Now, we're directed to those particular events we know are reportable and which require careful consideration," she says. "Everything that's reported isn't lumped together in a stack of paper that we receive daily, and we now have an electronic system for sorting them out."
The IRB now can spend its time on the events that truly are important and should be reported, which improves compliance, she adds.
Here's how the institution made the change:
1. Preparation is key.
For about a year, a group of six human research ethics staff and information technologies staff met weekly to discuss ideas and logistics for improving the UP/SAE reporting system.
The meetings, lasting two to three hours, focused on creating a logistical algorithm or decision tree, which could be completed online by principal investigators (PIs) and study coordinators.
"As we went through this process, formulating questions for the decision tree, we received input from the IRB chairs and from users, including investigators," Mackman says. "We put in a huge effort to make sure we had not only incorporated a user interface, but captured all the necessary information so the IRB could review the UPs that were being reported."
2. Design a decision tree.
The decision tree was intended to help PIs understand whether a particular problem was reportable or not.
"The decision tree was based on federal guidance," Mackman notes.
The human subjects research office at UNC includes a flow chart, one-page version of the decision tree on the public access part of its Web site at http://research.unc.edu/ohre/ohre_up_submission.php.
Basically, the decision tree asks these questions:
- Did this event occur at a site for which a UNC-CH IRB had direct oversight responsibility or involve a research participant at one of those sites?
If yes, then:
- Was the event unexpected in nature, severity, or frequency?
- Was the event related or possibly related to participation in the research?
- Does the event suggest that the research places subjects or others at greater risk of harm than was previously known or recognized?
If no, then:
- Has a determination been made by the research sponsor, coordinating center, DSMB/DSMC or other centralized monitoring group that this event meets the criteria for an unanticipated problem (i.e., unexpected, related to the research, and suggesting greater risk than previously recognized)? Please note that individual "IND safety reports" from external sites are generally NOT reportable, because their implications for the study cannot be understood. External events should not be reported unless accompanied by an aggregate analysis that establishes their significance and a corrective action plan that addresses the problem.
3. The IRB chair reviews all reports that answer "yes" to first three questions.
If a PI or CT coordinator answer "yes" to the questions about whether the event occurred at a site subject to the UNC IRB, whether the event was unexpected in nature, and whether the event was related to research, then it's automatically sent to the IRB chair to review.
Investigators may answer "yes" or "no" about the event's risk to subjects, but the IRB chair will make the final determination on that question, Mackman explains.
If the IRB chair determines that the event does pose a greater risk of harm than previously known or recognized, then the event is deemed a UP, and it's reported to the full board, she adds.
4. Anticipated AEs are reported in an aggregate report.
"Some AEs are UPs, and others are not," Mackman notes.
For those that are not unanticipated, the IRB will see those reported in an annual review, she says.
"They're summarized in aggregate at the time of annual review," Mackman says.
However, everything that is reported, whether the answers are "yes" or "no," is captured and saved as data, she adds.
"It doesn't go away precisely for the reason that if a PI has a question, we can go in and look at what they submitted and see what they said about the event," Mackman explains. "The IRB is definitely there to help, and the Web portal is there to provide guidance."
5. Train IRB and CT site prior to implementation.
"We provided online training modules for users so they were familiar with the system and understood the logic behind it," Mackman says. "They learned how to use it, how reports were processed, and they provided training for IRBs for how they were going to be reviewing these online reports."
Training sessions were provided in group presentations with the online system projected on an overhead screen. They took place in group settings two to three months before the June 1 deadline for the new online reporting system.
The training sessions helped the office achieve buy-in and ensured a smooth transition to the new system. They also gave investigators and CT staff an opportunity to provide feedback on the reporting process.
"By the time we launched the system, investigators and study coordinators were familiar with it," Mackman says. "They were highly receptive to the online submission system and were excited when they saw the project as it unfolded."
6. Include information for sponsors.
Sponsors often cause increases in SAE/UP reporting, pushing CT sites to report every event that occurs.
To address this issue, the Web site also contains a link to a letter from the UNC IRB, advising sponsors that its new reporting process meets all federal regulations, Mackman says.
"For many years, sponsors, researchers, and Institutional Review Boards (IRBs) have over-interpreted these regulations, and this has resulted in over-reporting of adverse events," the June 3, 2009, letter states. "Much of this reporting has been of questionable value to our shared goal of protecting subjects."
The letter also outlines the definitions of unexpected events, and says that any event meeting these criteria must be reported to the IRB, which will determine whether the research places subjects or others at a greater risk of harm than previously recognized.
"If an event has been determined to constitute an unanticipated problem involving risks to subjects or others, it follows that the report should be accompanied by a corrective action plan to address the problem," the letter continues.
After the online reporting process' launch, the office called a meeting of the core group to ensure there were no problems that needed to be tackled, she notes.
"It was a long process, but putting that amount of thought up front resulted in a smooth system," Mackman says.
A new online decision tree for reporting unanticipated problems (UPs) and serious adverse events (SAEs) has helped a research ethics office reduce unnecessary paperwork and reports and improved compliance with the institution's policies and federal regulations, an IRB compliance coordinator says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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