The idea is to distinguish between adverse events and unanticipated problems in clinical trials, and to clarify when problems must be reported to institutional review boards, FDAnews reports.

And after releasing the final guidance, the agency will “probably institute regulatory changes to make it clearer,” Jean Toth-Allen, a biophysicist with the FDA’s Good Clinical Practices Program, told the annual conference of the Association of Clinical Research Professionals, according to FDAnews. (Here is the draft guidance from last year).

As you may know, a sponsor must report serious and unexpected adverse events to the FDA. While clinical investigators aren’t required to report adverse events that don’t fall into this category to the IRB, they must record all adverse events on case report forms and submit them to the FDA in annual reports, Toth-Allen told the crowd, according to FDAnews.

The regs on devices stipulate that clinical investigators must report unanticipated adverse device effects within 10 working days to the sponsor and the IRB. In federally funded trials, even a serious adverse event might not have to be reported to HHS’ Office for Human Research Protections if it were anticipated, FDAnews writes, but it still would have to be reported to the FDA.