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COVID-19 clinical trial guidance

The NSW Office for Health and Medical Research developed the NSW Health COVID-19 Guidance on Clinical Trials to assist those involved in the conduct of clinical trials disrupted by the pandemic and response.

The guidance, modelled on similar advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, is designed to assist operational requirements in NSW. The latest version of the guidance is available below:

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.

Please note there are currently no revision plans for this guidance document. As the COVID-19 response evolves and eases, the guidance provided may not be applicable for new studies commencing at NSW Public Health Organisations. For any queries, comments and feedback on the document, please contact clinicaltrialsNSW at clinicaltrialsNSW@health.nsw.gov.au.

For up-to-date information on the COVID-19 Pandemic response visit NSW Health COVID-19.

Updated 4 months ago