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We are working to improve the quality of clinical trials conducted in regional NSW. We have developed a range of resources to assist those working in clinical trials including a capacity and capability audit and an education and training needs analysis.
These initiatives are supporting the rollout of the National Clinical Trials Governance Framework and improving the viability of clinical trials in rural and regional NSW.
Our community of practice for clinical trials coordinators meets monthly for online presentations and workshops discussing a range of topics with a focus on quality and the delivery of clinical trials.
To be included on the mailing list for events and updates please email hmriclinicaltrials@hmri.org.au
The Clinical Trials Roadmap is an interactive resource developed for our partner organisations to help staff understand, develop, plan, and undertake clinical trials. The roadmap sets out key steps, resources, and contacts, and provides guidance for common clinical trial scenarios.
You can find the Roadmap at ctroadmap.hmri.org.au
A new podcast has been produced by NSW Regional Health Partners, Sydney Health Partners and Maridulu Budyari Gumal (SPHERE) to support researchers and clinicians prepare for clinical trial audits as the new national framework comes into effect.
Episode 1 explores all things audits: what they are, why they’re important, and how to prepare.
Episode 2 explores monitoring clinical trials for quality and safety to make sure the trial is running in accordance with regulations and the trial protocol. Appendix Monitoring Resources
In March 2023, the National Clinical Trials Governance Framework came into effect.
Developed by the Australian Commission for Quality and Safety in Healthcare, it’s the first step towards a nationally consistent approach to the accreditation of health services conducting clinical trials.
The framework will ensure clinical trials meet required standards, which will have implications for the ongoing accreditation of public health services.
To help sites prepare for audits, the three Translation Centres have also developed an Audit Ready Resource Pack that includes a presentation
introducing the concepts of clinical trials audits and Good Clinical Practice, a site audit checklist, and guidelines for developing Standard Operating Procedures for external clinical trial audits.
Download the PowerPoint presentation – Applying GCP to Audits of Clinical Trials
Download the Guidelines for developing a Standard Operating Procedure
Download the Audit Checklist
For more information, contact our Clinical Trials Network Coordinator, Catherine Johnson hmriclinicaltrials.@hmri.org.au or
