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COVID-19 clinical trial guidance

The NSW Office for Health and Medical Research has drafted the NSW Health guidance for sponsors, researchers, HRECs and RGOs for conducting clinical trials affected by the COVID-19 situation.

The guidance, modelled on similar advice from the HRA in the UK, is designed to assist operational requirements in NSW and will be continually updated as the situation evolves. An updated version (Version 2) of this guidance document has now been released. Changes have been made to this document to incorporate frequently asked questions, clarify previous guidance information and reflect shifts in COVID-19 impact on the sector.

The Commonwealth Department of Health, with input from state and territory jurisdictions has produced a set of principles that are intended to have application nationally. These principles are available on the Department of Health website.

The Commonwealth principles occasionally contain some granular direction. Public Health Organisations that feel that the national principles conflict with the NSW guidance should contact clinicaltrialsNSW at clinicaltrialsNSW@health.nsw.gov.au to obtain advice on how to respond locally.

While the intent of the guidance is specifically for clinical trials, institutions are encouraged to use their reasonable judgment when applying the guidance to other clinical research studies.

For any queries, comments and feedback on the documents, please contact clinicaltrialsNSW at clinicaltrialsNSW@health.nsw.gov.au.

Updated 2 months ago