COVID-19: Queensland Health Operational Guidance for sponsors, trial sites, ethics committees, research governance officer/s and researchers

Topics:COVID-19

This operational guidance is designed to assist practical application of the national principles in Queensland and will be continually updated as the pandemic situation evolves.

Find the guidance here. Updates will be highlighted in yellow at each issue.

While the intent of the guidance is specifically for clinical trials, institutions may apply it to other research domains. The overarching principle embodied in these guidelines is the safety of all patients and participants: safety is paramount and of the utmost importance.

Temporarily halting a study is a serious consideration, as the successful completion of a study is an important ethical endpoint.

A study should only be suspended if there is no practical way of allowing it to achieve its primary outcomes during the COVID-19 pandemic.

Closing a study is a serious consideration, as the successful completion of a study is an important ethical endpoint.

COVID-19: Queensland Health Operational Guidance for sponsors, trial sites, ethics committees, research governance officer/s and researchersCOVID-19: Queensland Health Operational Guidance for sponsors, trial sites, ethics committees, research governance officer/s and researchersA study should only be stopped if there is no practical way of allowing it to achieve its primary outcomes during the COVID-19 pandemic, and/or if it will not be possible to complete the study within an appropriate timeframe after the COVID-19 pandemic.

For any queries, comments and feedback on the documents, please contact the Queensland Clinical Trials Coordination Unit at [email protected]