Approvals

Ethics and regulatory approvals

The BEAT COVID-19 study obtained central ethics approval from the Sydney Local Health District Human Research Ethics Committee (SLHD HREC) on 20 July 2020.  

On the basis of this ethics approval, authorisation may be sought to conduct this study within any NSW/QLD/VIC/SA/WA/ACT public health organisation and/or within any private organisation which has entered into an appropriate memorandum of understanding with the Sydney Local Health District, Sydney Local Health Network or the Sydney South West Area Health Service. Participating institutions outside of this network will be required to obtain local HREC approval prior to participating.

The study also requires notification to the Therapeutic Goods Administration (TGA) under the Clinical Trials Notification (CTN) Scheme. The CTN submission will occur with each new intervention incorporated into the study.

 

ANZ Clinical Trial Registry (ANZCTR)

The BEAT COVID-19 Study has been prospectively registered on the ANZCTR and can be viewed here:  ACTRN12620000566932.