Safety Monitoring and Reporting in Clinical Trials

The National Health and Medical Research Council (NHMRC) has issued new Guidance on safety monitoring and reporting in clinical trials. This Guidance will replace the existing 2009 Australian Human Ethics Committee Position Statement: Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods.
This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.
Guidance for Safety Monitoring and Reporting in Clinical Trials; involving therapeutic goods, (2016)