Professional Development Workshop Governance Approval for an Investigator-Initiated Clinical Trial: a Scenario-Based Workshop. A professional development workshop for research managers and administrators, across all sectors, presented by the Australasian Research Management Society (ARMS) NSW Chapter. With the generous support of the Kolling Institute of Medical Research, Northern Sydney Local Health District, and with support from the ARMS Ethics and Research Integrity Special Interest Group and its Australasian Ethics Network Stream. Many Australian universities, medical research institutes and hospitals are involved in securing approval for and conducting clinical trials. Commercially sponsored clinical trials have the benefit of significant resources to ensure that the trial adheres to legal requirements, best practice and good clinical practice; however, they are the smaller proportion of clinical trial activity conducted within NSW Public Health Organisations. It is investigator-initiated, institution-sponsored clinical trials that could significantly change healthcare delivery across the state, and yet they often experience unnecessary delays in receiving approvals. This professional development workshop will provide an introduction to the Australian and NSW clinical trial landscape and then deliver a practical scenario-based workshop to provide advice for those involved in non-commercially-sponsored clinical trials, including staff within universities, medical research institutes and hospitals. The presenters and facilitators will be practicing research governance and clinical trials staff, who will guide you in working through a real-world scenario to give you hands-on insights into what it takes to get clinical trials approved within a hospital environment. Research managers and administrators have a critical part to play in successful approvals and ongoing governance of clinical trials, so come along to learn more about how to do this in practice. Date: Thursday 23 April 2015, 9am–2:15pm Venue: TBC (either the Kolling or UNSW) Cost: Time 9:00 9:05 9:50 10:10 Members: $60 Non-members: $80 Program Welcome The changing landscape for clinical trials in Australia (Dr Gordon McGurk) Introduction to clinical trials, and associated responsibilities and risks Workshop – Part A The research project will be introduced. Workshop participants will work with facilitators to identify the initial risks and potential mitigation strategies. 11:10 11:30 13:15 Morning tea Workshop – Part B Further information related to the conduct of the study will be uncovered. Participants will determine what other mitigation strategies will need to be implemented before approval is given and patients can be recruited into the trial. Networking lunch (concluding 2:15pm) About the presenters and facilitators Karyn Joyner, Chief Operating Officer of Research at the Kolling Institute of Medical Research Karyn is Chief Operating Officer of Research at the Kolling. She was previously the Research & Operations Manager at the Kids Research Institute, The Children’s Hospital at Westmead, where she was responsible for managing laboratories and animal housing, clinical trials development, ethics and governance approvals, IP & commercialisation, resource optimisation, and strategic development. Karyn is an experienced senior executive with more than 18 years in research leadership and management across commercial, university and health sectors, including working in pharmaceutical regulatory affairs and research planning, entrepreneurial commercialisation and business development, and health and medical research operations. Gordon McGurk Ph.D., Director, Clinical Trials Section, National Health & Medical Research Council Gordon leads the Clinical Trials Section of the NHMRC which is focusing on implementation of the Australian Government’s commitments to streamlining ethics and research governance approvals for clinical trials. His previous roles at NHMRC have included a focus on issues around research integrity and the Australian Code for Responsible Conduct of Research, and for development and implementation of strategies for monitoring the use of public funding for health and medical research. He currently chairs the Australian and New Zealand Standards subcommittee responsible for developing AS/NZS 2243.3 (2010): Microbiological Containment : Safety in Laboratories, and is a board member of the association of biosafety for Australia and New Zealand. Gordon has a Doctor of Philosophy from the University of Edinburgh, for research in genetics and molecular biology. Maria Mury, Research Governance and Compliance Manager, Northern Sydney Local Health District Maria is responsible for the governance of all research activities across the NSLHD to ensure compliance with the relevant Hospital & NSLHD policies and procedures, NSW Health Directives and other relevant State and Federal guidelines, regulations and legislations. Her role has a strategic focus on developing and implementing the NSLHD’s Research Risk Management and Mitigation program as well as providing advice to the Chief Operating Officer for Research with regards to the development and implementation of governance structures that support research. Maria has worked in medical research for over 15 years; she is a registered nurse and has held previous positions such as executive officer for an NHMRC accredited HREC and project manager for large randomised clinical trials in medical oncology.
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