Guidance for Safety Monitoring and Reporting in Clinical Trials

The National Statement on Ethical Conduct in Human Research 2007 (updated 2018) recognises that sponsors, investigators/researchers, institutions and Human Research Ethics Committees (HRECs) all have responsibilities to monitor clinical trials. This Guidance is designed to clarify the responsibilities of all parties in relation to reports of adverse events, including serious adverse events  and suspected unexpected serious adverse reactions, occurring in clinical trials of investigation medical products and devices (IMPs and IMDs) for which institutions are responsible and for which the Human Research Ethics Committees (HRECs) have reviewed and approved.

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving IMPs and IMDs. 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 (PDF, 814KB)

NHMRC has developed the following documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics: