Guidance and supplementary guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods

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The National Statement on Ethical Conduct in Human Research 2007 recognises that sponsors, investigators/researchers, institutions and HRECs all have relevant responsibilities. This Guidance, which replaces the Australian Health Ethics Committee’s 2009 Position Statement, is designed to clarify the responsibilities of all parties in relation to reports of adverse events (AE), including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), occurring in clinical trials 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 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.

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:

  • Data Safety Monitoring Boards (DSMBs)
  • Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.

The supplementary guidance on Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods should be read alongside the Australian Code for the Responsible Conduct of Research (2007) (the Code).

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Further information on the development of the NHMRC Guidance, including a consultation paper and final report can be found on the NHMRC website.