National Clinical Trials Governance Framework Committees

The National Clinical Trials Governance Framework Committees were convened comprising members with relevant expertise and experience in the clinical trials sector.

List of Phase 2 Advisory Committee members (2019-2020)

The role of the Advisory Committee is to provide high level guidance and advice on the deliverables of the project and provide a point of liaison between the Commission and peer groups.

Committee member name	Committee contribution	Role title and organisation	State
Prof Chris Brook PSM	Chair	Chair, health policy consultation, CTPRG Chair and independent expert	VIC
Prof Erwin Loh	Deputy Chair - Hospital administrator	Group Chief Medical Officer, St Vincent’s Health Australia	VIC
Prof Robyn Aitken	Clinical trials (clinical - nursing)	Professor of Nursing, College of Nursing and Midwifery Flinders University	SA
Ms Helen Aunedi	Industry	Country Head, Country Clinical Operations, Roche Australia Pty Ltd.	National
Ms Jillian Barr	National Health and Medical Research Council (NHMRC)	Director, Ethics and Integrity; Research, Quality and Priorities Branch, NHMRC	Commonwealth
Mr Adrian Bootes	Commonwealth Department of Health	Assistant Secretary, Prescription Medicine Authorisation Branch, Therapeutic Good Administration, Commonwealth Department of Health	Commonwealth
Prof Nicholas Brown	Representative of Universities Australia	Professor of Allied Health Research, University of Canberra	National
Ms Allyson Essex	Commonwealth Department of Health	Assistant Secretary, HERD Health Economics and Modelling Branch	Commonwealth
Dr Jodi Glading	Clinical Trials Project Reference Group (CTPRG)	Deputy Chief Medical Officer, Health Professional Policy and Advisory Services Group, Tasmanian Department of Health	TAS
Dr Robert Herkes	Chief Medical Officer	Australian Commission on Safety and Quality in Health Care	National
Ms Elizabeth Heyer	Clinical trials research coordination	Clinical trials Coordinator, Townsville Hospital and Health Services	QLD
Sue Jenkins-Marsh	Clinical trials research coordination	Manager, Townsville Research Education, Support and Administration Unit, Townsville Hospital and Health Services	QLD
Ms Anne McKenzie AM	Consumer representative	Head of the WA Consumer and Community Health Research Network	WA
Ms Terrie O' Brien	Commonwealth Department of Health	Director, Clinical Trials Section, Health and Medical Research Office, Health Economics and Research Division, Department of Health	Commonwealth
Dr Antonio (Tony) Penna	Clinical Trials Project Reference Group (CTPRG)	NSW CTPRG Representative. Executive Director, Office for Health and Medical Research, NSW Ministry of Health	NSW
Mr Ian Pieper	Expertise in ethics and governance process	Director, Research Ethics and Governance Office, ACT Health	ACT
Ms Nicole Rasmussen	Safety and Quality Officer	Director, Patient Safety and Improvement at Alfred Health	VIC
Bernadette Swart	Research Governance Officer	Manager, CALHN Research Services, SA Health	SA
Angela Watt	Research Governance Officer	Director Research Governance and Ethics, Melbourne Health Office for Research, Royal Melbourne Hospital	VIC
Dr Margaret Way	Safety and Quality Officer	Executive Director Innovation, Quality, Research and Education at Sunshine Coast Hospital and health Service	QLD
Prof John Zalcberg	Representative of investigator-led trials	Chair, Australian Clinical Trials Alliance (ACTA)	National
Dr Sara Watson	Research Governance Officer	Director, Clinical Safety and Quality Office of the Chief Executive Officer	NT
Jessica Southwood	Clinical trials research coordination	Statewide Research Coordinator, Office of Research, Department of Health & Wellbeing	SA
Associate Prof Bhavini Patel	Research Governance Officer	Executive Director, Medicines Management, NT Department of Health	NT

List of Steering Committee members (2018-2019)

The Steering Committee set out to:

Support delivery of the project in line with the requirements of the Commission and the expectations of the Department of Health
Provide advice on the development of the National Clinical Trials Governance Framework and high level implementation plan
Facilitate engagement with peer groups about the project

Committee member name	Committee contribution	Role title and organisation	State
Prof Chris Brook PSM	Chair	Chair, health policy consultation, CTPRG Chair and independent expert	VIC
Assoc. Professor Robyn Aitken	Clinical trials (clinical - nursing)	Director, Collaborative Academic Health Science Research	NT
Ms Helen Aunedi	Industry	Country Head, Country Clinical Operations, Roche Australia Pty Ltd.	National
Ms Jillian Barr	National Health and Medical Research Council (NHMRC)	Acting Executive Director, Research, Quality and Priorities Branch, NHMRC	Australian Government
Professor Ben Canny	Universities Australia	Head, School of Medicine College of Health and Medicine University of Tasmania	National
Dr Jodi Glading	Clinical Trials Project Reference Group (CTPRG)	Deputy Chief Medical Officer, Department of Health and Human Services, Tasmania	TAS
Dr Robert Herkes	Chief Medical Officer	Australian Commission on Safety and Quality in Health Care	National
Ms Erica Kneipp	Australian Government Department of Health	Assistant Secretary, Office of Health and Medical Research, Australian Government Department of Health	Australian Government
Professor Chris Levi	Clinical trials (clinical - physician)	Executive Director, The Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)	NSW
Professor Erwin Loh	Hospital administrator	Group Chief Medical Officer and General Manager Clinical Governance, St Vincent’s Health Australia	National
Ms Anne McKenzie AM	Consumer representative	Head of the WA Consumer and Community Health Research Network	WA
Dr Grant Pegg	Therapeutic Goods Administration	Director, Experimental Products Section, Pharmacovigilance and Special Access Branch	Australian Government
Dr Antonio (Tony) Penna	Clinical Trials Project Reference Group (CTPRG)	NSW CTPRG Representative. Executive Director, Office for Health and Medical Research, NSW Ministry of Health	NSW
Mr Ian Pieper	Expertise in ethics and governance process	Ethics Manager Research Ethics and Governance Office, ACT Health Directorate	ACT
Ms Susan Richmond	Clinical trials research coordination	Research Officer, Clinical Trials Unit, James Cook University, Cairns	QLD
Prof Steven Webb	Representative of investigator-led trials	Senior Staff Specialist in Intensive Care Medicine at Royal Perth Hospital and a Professor of Critical Care Research in the School of Public Health and Preventive Medicine at Monash University.	WA

Contact

If you have any questions about the National Clinical Trials Governance Framework project please contact Bernadette Aliprandi-Costa and the project team via email HMR@safetyandquality.gov.au or phone 02 9126 3600.