Clinical Trial SUSAR Reports inDorothy Toh, Chong Limei and Foo Yang Tong explain the new electronic expedited reporting system for suspected unexpected serious adverse events in clinical trials.

摘要

This article describes Singapore's new web-based expedited safety reporting system for suspected unexpected serious adverse reactions in clinical trials. The system, implemented in stages between April and November 2008, was developed to facilitate the electronic submission of serious adverse events/Council for International Organizations of Medical Sciences reports to the Health Sciences Authority. This, in turn, would allow for a timely and pertinent analysis of the safety profile for investigational products with ongoing clinical trials in Singapore and enable the HSA to assess whether any follow-up action is required of the sponsor and/or investigators.Singapore's Medicines (Clinical Trials) Regulations stipulate the requirement to notify the licensing authority in writing of any serious adverse event that is likely to affect the safety or well-being of the subject, which has arisen during the clinical trial or which has become known from reports of similar clinical trials conducted elsewhere. Before 2008, SUSARs arising from clinical trials in Singapore were manually entered into an electronic database, which was constantly updated and analysed by the Clinical Trials Branch at the HSA. The system had its limitations: the manual generation of safety profile reports for every product was time-consuming and it was not possible to compare the adverse event profile of investigational products within similar pharmacological classes. It was clear that automating several processes involved in the management of expedited safety reports would increase the efficiency of the system both for internal and external customers.