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ADVERSE EVENT REPORTING

Drug clinical trials
All serious adverse events (SAEs) occurring during drug clinical trials must be reported to the applicable regulatory authorities within set timescales.

Medical device clinical investigations
The task of determining the role of a medical device in an adverse incident is particularly difficult during clinical investigations. In part, this is because some problems that may be associated with the device are not known. For this reason and because of the importance of properly managing adverse events during clinical investigations, clinical investigators and other relevant persons involved with the conduct and monitoring of the clinical investigation should have a clear understanding of how to interpret these events. 

Donawa Lifescience Consulting (DLC) recognizes the importance of timely and effective reporting of adverse events. As such, DLC has developed the following tools that our clients can use to facilitate compliance with European requirements: 

• Easy-to-understand guidelines for sponsors and investigators to facilitate reporting of adverse events in compliance with applicable regulations.
  
• Training for sponsors, monitors and investigational-site personnel which focuses on the importance of recognising the types of clinical and medical conditions that could represent reportable adverse events.
  
• The DLC Device Clinical SOP ‘Adverse event reporting during clinical investigations’, which covers US and European reporting requirements, is available for use by our clients during clinical studies, or can be incorporated into the sponsor’s own operating system.