ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesHuman Research EthicsGuidance and supplementary guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (Guidance: NHMRC | 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Guidance and supplementary guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (Guidance: NHMRC | 2018)

Published/Released on February 23, 2018 | Posted by Admin on May 3, 2018 / , , , , , , , , ,
 


View full details | Go to resource


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…

Access the guidance material



Resources Menu

Research Integrity


Human Research Ethics

0