One-page form aids in serious event reporting
Questions should go into gray areas
How investigators report serious adverse events (SAEs) can be subject to gray zones. Answers are not always a clear "yes" or "no."
For this reason, an IRB should have an SAE report form available to help clarify investigators’ responses, suggests Brian A. Gladue, PhD, CIP, executive director for the office of research compliance at the University of North Texas Health Science Center in Fort Worth.
"The investigator has to determine whether or not the event meets one of the standard criteria for serious adverse event, such as death, life-threatening situation, hospitalization," Gladue says. "And how is the event related to the protocol?"
An SAE report form should allow for a small range of answers, he says.
"It encourages more reporting if the answers are not just yes’ or no,’" Gladue says. "We find that people are reluctant to say yes’ or no.’ So having a range gives them an opportunity to check something."
But if the investigator answers with anything other than a definite "no," the IRB will look into it, he adds.
"If the investigator is convinced the event is not related to the protocol and their explanation makes sense, then we’d concur," Gladue says.
The IRB provides investigators with an SAE checklist to get them to think about the kind of information the IRB needs, he says.
"Then they attach all of the relevant data, usually as it relates to the study," he adds. "We ask for what the determinations are and what they recommend."
The IRB reviews the SAE information and decides to accept it as-is or to modify the informed consent form.
The attached information should include a description of what happened, any available medical or hospital record and diagnostic record associated with the event, and lab tests associated with the event, Gladue says.
"The form is a starting point, not a single, end-all document," he explains. "They have to attach relevant information, and if this is not forthcoming the IRB will ask them for more information."
For example, the SAE report also should include the investigator’s determination of the event and how it’s related to the kind of event they’re reporting, Gladue says.
"Some events are clearly related to the study, and some are unrelated, or you have to stretch it to have it related," he says.
Gladue offers this example of how gray areas can develop: "Suppose someone is taking a test article associated with diabetic foot ulcers, a cream or treatment, and the person ends up in the emergency room over the weekend because he broke his shoulder when cleaning gutters."
The investigator might say this accident is definitely not related to the study. But someone else might argue that the participant could have been woozy from the study product and that could have contributed to his fall, Gladue explains.
"So the IRB will look at the test article’s adverse events to see if wooziness is listed," he says.
Any adverse events result in a reassessment of what’s going on with the study.
"The idea is to have a system available for investigators to be comfortable about reporting unusual events that occur in their protocols, and the SAE form is the starting point for that," Gladue says. n
