We have introduced a new form for sponsors of clinical trials to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA. This form will ensure that consistent and complete information is provided to the TGA, which will facilitate our rapid review of these reports. There are no changes to the roles and responsibilities for those involved in clinical trial safety reporting or the requirements to report SSI/USM to the HREC and other relevant bodies.
The TGA requires the submission of Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) by sponsors, as described in the Australian clinical trial handbook and the guidance on Safety monitoring and reporting in clinical trials involving therapeutic goods published by the National Health and Medical Research Council (NHMRC).
The TGA also holds the Adverse Event Management System (AEMS) where Suspected Unexpected Serious Adverse Reactions (SUSARs) are submitted. Adverse events related to medical devices can be submitted via the medical device incident reporting and investigation scheme (IRIS).
A summary of the roles and responsibilities for clinical trial safety reporting of SSIs and USMs can be found on our website. For complete information on safety reporting responsibilities refer to the guidance on Safety monitoring and reporting in clinical trials involving therapeutic goods published by the NHMRC.
Clinical Trial Significant Safety Issue/Urgent Safety Measure (SSI/USM) safety reporting form: