C18. Stories from the Summit: Harnessing the National Clinical Trials Governance Framework to deliver Health Service Safety, Quality, Culture, Capacity to the Community
Tracks
Clinical Workforce and Capacity
| Friday, June 14, 2024 |
| 2:45 PM - 3:45 PM |
| C2.5+C2.6 |
Chair & Speakers
Mr Simon Windsor
Manager, Research Governance And Ethics
SALHN
Chair: Stories from the Summit: Harnessing the National Clinical Trials Governance Framework to deliver Health Service Safety, Quality, Culture, Capacity to the Community
Abstract
The Challenge: Traditionally siloed teams
The Summit: Networked approach
The National Clinical Trials Governance Framework was implemented in Australia in 2023. The Core principles
require a Clinical Trial Service to be Patient centred and meets the needs of the community, maintain a Safe environment, ensure Quality, conduct research with Risk and proportionality as well as Accountability and transparency.
Prof Andrew Bersten will provide an executive overview of development and deployment of what is a new era in clinical trials for Australia. This insightful Information session will discuss Quality management systems and reporting at a team and organisational level, Culture aspects that ensure known workforce opportunities and participation, systems and funding that build Capacity and feedback from the Community of Southern Adelaide. This implementation enabled research in the jurisdiction to grow into a major focus for the Board and Executive of the Health Service.
We will conclude the information session with 4 take home considerations:
1 Authority: health Service Governance as a risk management tool
2 Alignment: Corporate, Clinical, Research, Consumer Systems
3 Embed Clinical Trials into Consumer, Corporate, Clinical, Research, Governance, Risk, Workforce & Data
4 Employ situational awareness to procurement : Federal, State, Entity, Executive, Unit (up and down)
The Summit: Networked approach
The National Clinical Trials Governance Framework was implemented in Australia in 2023. The Core principles
require a Clinical Trial Service to be Patient centred and meets the needs of the community, maintain a Safe environment, ensure Quality, conduct research with Risk and proportionality as well as Accountability and transparency.
Prof Andrew Bersten will provide an executive overview of development and deployment of what is a new era in clinical trials for Australia. This insightful Information session will discuss Quality management systems and reporting at a team and organisational level, Culture aspects that ensure known workforce opportunities and participation, systems and funding that build Capacity and feedback from the Community of Southern Adelaide. This implementation enabled research in the jurisdiction to grow into a major focus for the Board and Executive of the Health Service.
We will conclude the information session with 4 take home considerations:
1 Authority: health Service Governance as a risk management tool
2 Alignment: Corporate, Clinical, Research, Consumer Systems
3 Embed Clinical Trials into Consumer, Corporate, Clinical, Research, Governance, Risk, Workforce & Data
4 Employ situational awareness to procurement : Federal, State, Entity, Executive, Unit (up and down)
Biography
Simon Windsor is a Fellow of Australasian College of Health Service Management and Medical Scientist with 19 years of healthcare experience. With International Clinical trial experience he led development of the National PICF in 2016 and was a member of the Informed PICF leadership team with CT:IQ since 2020.
Prof Andrew Bersten, MB, BS, MD, FANZCA, FJFICM, is professor and Director of Research at Southern Adelaide Local Health Network, in Adelaide, Australia. He has authored chapters for medical books and published numerous refereed articles in medical journals. Highly regarded internationally for his novel research into respiratory medicine, Dr. Bersten’s work led directly to the adoption of innovative diagnostic and therapeutic protocols in intensive care and respiratory medicine. Prof Bersten is also co-author of Oh’s Intensive Care Manual, 7th Edition.
Andrew Bersten
Executive Director Research
Southern Adelaide Local Health Network
National Clinical Trials Government Framework and Data Governance in Public Health Service
Biography
Andrew Bersten is Executive Director of Research Strategy at Southern Adelaide Local Health Network, centred at Flinders Medical Centre, and Professor in the College of Medicine and Public Health, Flinders University. In addition to ongoing research interests in acute lung injury and ARDS, he has been the ICU Director and the Network Director Division of Medicine prior to the current role.
Kate Beard
Study Start-up Manager
Cmax Clinical Research Pty Ltd
Management approach to Clinical trials and privacy requirements in early phase clinical trials
Biography
Kate Beard is a seasoned professional in the realm of early phase clinical trials, with over 20 years of dedicated experience at CMAX, Australia’s longest established, independent Clinical Research facility. Throughout her career, she has demonstrated a steadfast commitment to streamlining study processes, ensuring efficient and effective trial execution. Kate's wealth of experience, keen attention to detail, strategic mindset, and collaborative approach have made her an invaluable asset in supporting CMAX’s global client base to accelerate quality product development, delivering exceptional service.
