CDASH Standard Expands to Medical Devices

The Clinical Data Interchange Standards Consortium Clinical Data Acquisition Standards Harmonization (CDASH) project is expanding to devices, which means that its 16 domains — including demographics, adverse events and other safety categories — will be fully applicable to devices. “Some changes may be needed for adverse events, terminology and protocol deviations — things that may go wrong with devices that are not necessarily adverse events where the patient is concerned,” project director Rhonda Facile said.
Clinical Trials Advisor