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Review of safety monitoring & reporting of clinical trials in Australia

Safety monitoring and reporting requirements have been updated internationally, including in the United States and the European Union. In response to changes in safety monitoring and reporting that have occurred internationally, the NHMRC is reviewing whether the Position Statement and National Statement reflect contemporary approaches to safety monitoring and reporting, and if not, to determine options for achieving a safety reporting system that is efficient and reflects contemporary reporting requirements.

Read ACTA's submission on safety monitoring and reporting here