Final Guidance on Adverse Events in Clinical Trials Due Soon

May 9, 2008

The FDA will soon issue a final guidance distinguishing between adverse events and unanticipated problems in clinical trials, clarifying when the former have to be reported to an institutional review board (IRB).

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, said at the annual conference of the Association of Clinical Research Professionals.
It is the sponsor’s responsibility to report serious and unexpected adverse events to the FDA. While clinical investigators are not required to report adverse events that do not 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 said.

The regulations 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, but it still would have to be reported to the FDA.

The FDA’s draft guidance can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf.