Common use of PROJECT MILESTONES, REPORTING AND PAYMENTS Clause in Contracts

PROJECT MILESTONES, REPORTING AND PAYMENTS. In accordance with clause 12 of the Agreement, the Commonwealth and Queensland have agreed a Project Plan that sets out Queensland’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, Queensland will establish a state-wide Queensland Clinical Trials Coordination Unit (the QCTCU) that will: act as a central point of contact for sponsors, investigators, referrers and patients; include liaison points within Queensland Academic Health Translation Centres to develop networked clinical trial hubs across multiple Hospital and Health Services (HSS); include a Clinical Trial Capability Project to measure Queensland’s baseline clinical trials capability, including identification of under-represented clinical areas and current public-private partnerships, and achievements and improvements as a result of introducing new clinical trials models in Queensland; deliver a Clinical Research Coordinator Workforce Strategy; support the application of common, streamlined clinical trial processes; facilitate a coordinated and networked approach that also maximises clinical trials resource utilisation and participation; and implement a tele-trials model with satellite regional sites across Queensland, New South Wales and the Northern Territory to improve regional patient access to trials, with an initial focus on oncology. In accordance with clause 8 and 15 of the Agreement, milestones, their relationship to outputs, expected completion dates, relevant reporting dates and expected payments are set out in Table 1. Table 1: Milestones, reporting and payment summary Outputs Milestones Reports due Payments 2017-18 2018-19 2o19-20 2020-21 Establish new and enhanced central coordination unit in accordance with clause 8(a) of the Agreement. Establish the QCTCU including website and placement/identification of four liaison points within existing or emerging Queensland Academic Health Translation Centres. Initiate workforce support including education and training of research ethics and governance officers, and clinical research coordinators to build workforce competency and capability. Public launch of the QCTCU, associated website and liaison points. Delivery of the Clinical Trial Capability Project, including publication of at least 100 clinical trial site profiles on the QCTCU website to demonstrate the impact of the QCTCU on reducing the administrative load on clinical trial sites and approval timeframes. Delivery of a Clinical Research Coordinator Workforce Strategy to increase the clinical trial research capacity of regional and rural sites and junior staff, and integrate and support the state-wide coordination of trials. Publication on the QCTCU website of a new state-wide Clinical Research Coordinator Workforce Strategy including SOPs and guidelines Completion of formal analysis of clinical trial activity compared to baseline (to be provided in 2017-18 performance report and agreed with the Commonwealth) to demonstrate the impact of the QCTCU on reducing the administrative load on trial sites and approval timeframes, to support the business case for, and delivery of, the QCTCU as an effective and sustainable model. Completion of forward planning based on outcomes of analysis and business case. 30 April 2018 30 April 2019 30 April 2020 30 April 2021 $428,520 $257,160 $257,160 $257,160 Implement new and enhanced clinical trial data collection and reporting, in accordance with clause 8(b) of the Agreement. Full contribution of data to the National Aggregate Statistics (NAS) 2017-18, as agreed by the Clinical Trials Project Reference Group (CTPRG) Full contribution of data to the expanded NAS 2018-19, as agreed by the CTPRG. Full contribution of data to the expanded NAS 2019-20, as agreed by the CTPRG. Full contribution of data to the expanded NAS 2020-21, as agreed by the CTPRG. Establish and maintain new networks and partnerships in accordance with clause 8(c) of the Agreement. Delivery of pilot oncology tele-trials / satellite site model across Queensland. Publication and mandating of revised Standard Operating Procedures (SOPs) that include the tele-trials model. Review, and publication of analysis, of pilot oncology tele-trials model and revised SOPs based on outcomes. Delivery of expanded tele-trials model to disciplines other than oncology across Queensland and other partners. Tele-trials model integrated within regional health system arrangements, and impact analysis based on increased number of tele-trials compared to baseline (provided in annual performance report). Ongoing delivery of tele-trials model. Embed research and clinical trials processes in accordance with clause 8(d) of the Agreement. Active engagement with CTPRG, Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Sign off The Parties have confirmed their commitment to this Schedule as follows: Signed for and on behalf of the Commonwealth of Australia by __________________________________________ The Honourable Xxxx Xxxx MP Minister for Health / /2018 Signed for and on behalf of the State of Queensland by __________________________________________ The Xxx Xxxxxx Xxxxx MP Minister for Health and Minister for Ambulance Services / /2018

PROJECT MILESTONES, REPORTING AND PAYMENTS. In accordance with clause 12 of the Agreement, the Commonwealth and Queensland ACT have agreed a Project Plan that sets out QueenslandACT’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, Queensland ACT will establish a expand the recently established state-wide Queensland ACT Centre for Clinical Trials Coordination Unit (the QCTCUCCT) that will: act as a central point of contact for sponsors, investigatorsresearchers, referrers coordinators and patientsparticipants; include liaison points within Queensland Academic Health Translation Centres to develop networked clinical trial hubs across multiple Hospital provide centralised support and Health Services (HSS); include a Clinical Trial Capability Project to measure Queensland’s baseline coordination of all public sector clinical trials capabilitywithin ACT, including identification development of under-represented clinical areas and current public-private partnerships, and achievements and improvements as a result of introducing new clinical trials models in Queensland; deliver a Clinical Research Coordinator Workforce Strategy; support the application of common, streamlined clinical trial processes; facilitate a coordinated and networked approach that also maximises clinical trials resource utilisation and participation; and implement a tele-trials model with satellite regional sites across Queensland, mechanisms to enable New South Wales (NSW) residents to participate in ACT based trials; develop and the Northern Territory implement an innovative Information and Communication Technology (ICT) platform that will enhance clinical trial data and recruitment capability, and support efficient translation of research outcomes into practice improvement; and introduce a research mentorship program for new and early career researchers to improve regional patient access to trials, with an initial focus on oncologyenhance capability and research activity within ACT. In accordance with clause 8 and 15 of the Agreement, milestones, their relationship to outputs, expected completion dates, relevant reporting dates and expected payments are set out in Table 1. Table 1: Milestones, reporting and payment summary Outputs Milestones Reports due Payments 2017-18 2018-19 2o19-20 2020-21 Establish new and enhanced central coordination unit in accordance with clause 8(a) of the Agreement. Establish the QCTCU including website and placement/identification of four liaison points within existing or emerging Queensland Academic Health Translation Centres. Initiate workforce support including education and training of research ethics and governance officers, and clinical research coordinators to build workforce competency and capability. Public launch of the QCTCU, associated website and liaison points. Delivery of the Clinical Trial Capability Project, including publication of at least 100 clinical trial site profiles on the QCTCU website a project to demonstrate the impact of the QCTCU on reducing the administrative load on clinical trial sites inform system redesign and approval timeframesfindings provided in annual performance report. Delivery of a Clinical Research Coordinator Workforce Strategy clinical trials scorecard to assess ACT trial activity and inform strategic directions of future trials investments and partnerships in ACT Publication and distribution of revised Standard Operating Procedures (SOPs) for trials in the ACT. Delivery and public launch of a Single Point of Contact (SPC) for all clinical trials entering ACT. Signed agreements with the Australian National University, University of Canberra, university partners and other public and private health organisations to centralise coordination and management of trial conduct (including cross-institutional research governance) through the CCT. Delivery of an increase the in permanent clinical trial research capacity of regional and rural sites and junior staff, and integrate and support the state-wide coordination of trialscoordinator positions in ACT compared to baseline. Publication on the QCTCU website Delivery of a new state-wide Clinical Research Coordinator Workforce Strategy including policy to support stable and sustainable employment for clinical trial coordinators. Delivery of survey and review of Standard Operating Procedures (SOPs) for all ACT clinical trials, and update and publication of revised SOPs informed by review outcomes. Signed agreements with all ACT CCT partners to enable centralised management and guidelines Completion of formal analysis coordination of clinical trial activity compared to baseline (to be provided in 2017-18 performance report and agreed with the Commonwealth) to demonstrate the impact of the QCTCU on reducing the administrative load on trial sites and approval timeframes, to support the business case for, and delivery of, the QCTCU as an effective and sustainable model. Completion of forward planning based on outcomes of analysis and business casetrials within ACT. 30 April 2018 30 April 2019 30 April 2020 30 April 2021 $428,520 255,237 $257,160 153,225 $257,160 153,225 $257,160 153,225 Implement new and enhanced clinical trial data collection and reporting, in accordance with clause 8(b) of the Agreement. Full contribution of data to the National Aggregate Statistics (NAS) 2017-18, as agreed by the Clinical Trials Project Reference Group (CTPRG). Signed contract with vendor for development of innovative Information and Communication Technology (ICT) platform that will enhance clinical trial data and recruitment capability and support efficient translation of research outcomes into practice improvement. Full contribution of data to the expanded NAS 2018-19, as agreed by the CTPRG. Delivery of beta testing of innovative ICT system. Full contribution of data to the expanded NAS 2019-20, as agreed by the CTPRG. All clinical trials within reach of CCT captured within innovative ICT system. Full contribution of data to the expanded NAS 2020-21, as agreed by the CTPRG. NAS data requirements and automated reporting capability incorporated into innovative ICT system. Establish and maintain new networks and partnerships in accordance with clause 8(c) of the Agreement. Delivery Signed agreement between ACT and NSW to facilitate collaboration on development and operation of pilot oncology telea shared research ethics and governance information management system in partnership with NSW. Signed Agreement between ACT and NSW to streamline administrative functions and trial pathways to support cross-trials / satellite site model across Queenslandborder trial participation, including to enable NSW regional residents to participate in ACT based trials. Publication Signed agreement by ACT Health and mandating the Xxxx Xxxxxx School of revised Standard Operating Procedures (SOPs) that include the tele-trials modelMedical Research, ANU to facilitate translation of research into patient care and service improvement. Review, and publication of analysis, of pilot oncology tele-trials model and revised SOPs based on outcomes. Delivery of expanded tele-trials model to disciplines other than oncology across Queensland and other partners. Tele-trials model integrated within regional health system arrangements, and impact analysis based on increased number of tele-trials compared to baseline (provided in annual performance report). Ongoing delivery of tele-trials model. Nil Embed research and clinical trials processes in accordance with clause 8(d) of the Agreement. Active engagement with the Clinical Trials Project Reference Group (CTPRG), Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Sign off The Parties have confirmed their commitment to this Schedule as follows: Signed for and on behalf of the Commonwealth of Australia by __________________________________________ The Honourable Xxxx Xxxx MP Minister for Health / /2018 Signed for and on behalf of the State of Queensland Australian Capital Territory by __________________________________________ The Xxx Honourable Xxxxxx Xxxxx Xxxxxxxxxx MP Minister for Health and Minister for Ambulance Services / /2018

PROJECT MILESTONES, REPORTING AND PAYMENTS. In accordance with clause 12 of the Agreement, the Commonwealth and Queensland NT have agreed a Project Plan that sets out QueenslandNT’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, Queensland NT will consolidate and expand existing functions to establish a state-wide Queensland Clinical Trials Coordination Unit (the QCTCU) that will: act as a central point of contact (unit) for clinical trial sponsors, investigatorsresearchers, referrers coordinators and patientsparticipants that will: provide a single point of application for research ethics and site specific approvals; include liaison points within Queensland Academic provide a centralised source of advice and facilitate the introduction of standard operating procedures across all Northern Territory Department of Health Translation Centres sites, informed by strong Indigenous leadership, to develop networked support and encourage best practice and culturally appropriate research and recruitment, including for vulnerable populations; enhance clinical information systems and Information and Communication Technology (ICT) capability to assist clinical trial hubs across multiple Hospital recruitment, and Health Services (HSS)to facilitate NT participation in ongoing national reporting and streamlining activities; include and work with comparable units in Queensland and Western Australia to establish a Clinical Trial Capability Project formal partnership arrangement to measure Queensland’s baseline attract and support Northern Australia clinical trials, drawing on existing expertise in key research institutions and national clinical trials capability, including identification of undernetworks to inform and encourage high-represented clinical areas quality national and current public-private partnerships, and achievements and improvements as a result of introducing new clinical trials models in Queensland; deliver a Clinical Research Coordinator Workforce Strategy; support the application of common, streamlined clinical trial processes; facilitate a coordinated and networked approach that also maximises clinical trials resource utilisation and participation; and implement a tele-trials model with satellite regional sites across Queensland, New South Wales and the Northern Territory to improve regional patient access to international trials, with an initial focus on oncology. In accordance with clause 8 and 15 of the Agreement, milestones, their relationship to outputs, expected completion dates, relevant reporting dates and expected payments are set out in Table 1. Table 1: Milestones, reporting and payment summary Outputs Milestones Reports due Payments 2017-18 2018-19 2o19-20 2020-21 Establish new and enhanced central coordination unit in accordance with clause 8(a) of the Agreement. Establish and publically launch the QCTCU including website Northern Territory Clinical Trials Coordination Unit (NTCTCU), as a central point of contact for all clinical trial sponsors, researchers, coordinators and placement/identification participants entering NT. Finalise agreement within NT Health on centralised functions of four liaison points within existing or emerging Queensland Academic Health Translation Centres. Initiate workforce support including education and training of research ethics and governance officers, and clinical research coordinators to build workforce competency and capabilityNTCTCU. Public launch of the QCTCUNTCTCU website, associated website including a single submission format and liaison pointslocation for NT Clinical Trials and Human Research Ethics (HREC) applications. Delivery Implement revised NT Health-wide research governance processes. Design and conduct trial of community consultations. Finalise and distribute a single Standard Operating Procedure (SOP) for all clinical trials across NT Health sites, informed by strong Aboriginal leadership. All NT Health clinical trials coordinated by the NTCTCU and enter via the NTCTCU website. Consolidation of new clinical trials operating systems and governance mechanisms within NT Health operations. Complete a NT research needs assessment (including translational research), aligned with strategic priorities of the Clinical Trial Capability ProjectNT Department of Health and two Health Services. Complete monitoring and evaluation activities to identify impact, effectiveness of, and revisions to, the NTCTCU, including publication coordination of at least 100 clinical trial site profiles on the QCTCU website to demonstrate the impact of the QCTCU on reducing the administrative load on clinical trial sites and approval timeframes. Delivery of a Clinical Research Coordinator Workforce Strategy to increase the clinical trial research capacity of regional and rural sites and junior staff, and integrate and support the state-wide coordination of trials. Publication on the QCTCU website of a new state-wide Clinical Research Coordinator Workforce Strategy including SOPs and guidelines Completion of formal analysis of clinical trial activity compared to baseline (to be provided in 2017-18 performance report and agreed with the Commonwealth) to demonstrate the impact of the QCTCU on reducing the administrative load on trial sites and approval timeframes, to support the business case for, and delivery of, the QCTCU as an effective and sustainable model. Completion of forward planning based on outcomes of analysis and business casepathway. 30 April 2018 30 April 2019 30 April 2020 30 April 2021 $428,520 241,043 $257,160 144,553 $257,160 144,553 $257,160 144,553 Implement new and enhanced clinical trial data collection and reporting, in accordance with clause 8(b) of the Agreement. n/a Full contribution of data to the expanded National Aggregate Statistics (NAS) 20172018-1819, as agreed by the Clinical Trials Project Reference Group (CTPRG) Full contribution ). Commence mapping of data extraction capability in the Core Clinical System Renewal Program (CCSRP), including capacity to the expanded NAS 2018-19, as agreed by the CTPRGcollect total numbers of patients potentially eligible for trials. Finalise and implement an IT system for internal clinical trials management and external reporting. Full contribution of data to the expanded NAS 2019-20, as agreed by the CTPRG. Capture all clinical trials within reach of NTCTCU within IT system. Full contribution of data to the expanded NAS 2020-21, as agreed by the CTPRG. Capture data on recruitment as a proportion of all eligible patients. Establish and maintain new networks and partnerships in accordance with clause 8(c) of the Agreement. Delivery Establish and maintain a Project Steering Committee, to include all NT stakeholders involved in research ethics and clinical trials governance processes. Deliver promotional activities to raise awareness of pilot oncology telethe NTCTCU. n/a Finalise agreement xxxxxxx XX, Xxxxxxxxxx and Western Australia to attract and support Northern Australian clinical trials that seek to address public health priorities and areas of significant disease burden that contribute to the continuing gap in life expectancy between non-trials / satellite site model across QueenslandIndigenous and Indigenous Australians. Publication Completion of NTCTCU’s NT research needs assessment and mandating of revised Standard Operating Procedures (SOPs) evaluation, with recommendations for sustainable research structures that include the tele-trials model. Review, and publication of analysis, of pilot oncology tele-trials model and revised SOPs based on outcomes. Delivery of expanded tele-trials model to disciplines other than oncology across Queensland and other partners. Tele-trials model integrated within regional health system arrangements, and impact analysis based on increased number of tele-trials compared to baseline (provided in annual performance report). Ongoing delivery of tele-trials modelmeet population needs. Embed research and clinical trials processes in accordance with clause 8(d) of the Agreement. Active engagement with the Clinical Trials Project Reference Group (CTPRG), Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to develop a draft Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Active engagement with CTPRG, Commonwealth and ACSQHC to implement the national Clinical Trials Governance Framework. Sign off SIGN OFF The Parties have confirmed their commitment to this Schedule as follows: Signed for and on behalf of the Commonwealth of Australia by __________________________________________ The Honourable Xxxx Xxxx MP Minister for Health / /2018 Signed for and on behalf of the State of Queensland the Northern Territory by __________________________________________ The Xxx Xxxxxx Honourable Xxxxxxx Xxxxx MP Minister for Health and Minister for Ambulance Services / /2018