FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Experts Recommend How Device Trials Should Handle Adverse Events

Oct. 31, 2018
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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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