Guidance Documents

SLHD Guidance

1. Memo - CE - NSW Health Guidance for Clinical Trials Sponsors, Sites and Investigators & Establishment of SLHD  COVID-19 Clinical Trial Response Working Group

2. SLHD Guidance to investigators on the conduct of clinical studies during the COVID-19 pandemic - PUBLISHED 26 MARCH 2020

NSW Office for Health and Medical Research (OHMR)

1. DRAFT COVID-19 Clinical Trial Conduct Guidance - 19 March 2020 
         a).  COVID-19 Clinical trial guidance for HRECs and RGOs - 19 Mar 2020
         b). NSW Health Guidance Document COVID-19 and Clinical Trials for Sponsors

2. Guidance Summary

OTHER LINKS

1. NSW Health Guidance Document COVID-19 and Clinical Trials for Sponsors Sites and Researchers – 25 March 2020

2. NHMRC Clinical Trials Project Reference Group (CTPRG) “COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors” – 9 April 2020

3. FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. Guidance for Industry, Investigators, and Institutional Review Boards

Contains useful examples that supplement the advice in this document and the draft NSW Health Guidance Document

4. Guidance from the UK NHS Health Research Authority

5. Guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA)

6. EU Guidance

7. TGA Guidance Clinical trial processes - 31 March 2020