FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Experts Recommend How Device Trials Should Handle Adverse Events

Oct. 31, 2018

Sites running clinical trials for devices should document all adverse events and investigators’ responses even if they don’t ultimately report the events to regulators or Institutional Review Boards, a contract research organization executive told the MAGI clinical research conference in San Diego last week.

Drug trials must report all adverse events but device trials have a little more leeway. Still, in the old researchers’ saying, “If it’s not documented it’s not done,” said Rachel Silver-Kessler, director of clinical support services at IMARC Research, a Cleveland-based CRO.

She suggested that research coordinators track any adverse events that come up during a device trial and build a database around simple “yes/no” propositions, such as “was the event serious?” or “was it associated with the device?”

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