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 NT have agreed a Project Plan that sets out NT’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, NT will consolidate and expand existing functions to establish a central point of contact (unit) for clinical trial sponsors, researchers, coordinators and participants that will: provide a single point of application for research ethics and site specific approvals; provide a centralised source of advice and facilitate the introduction of standard operating procedures across all Northern Territory Department of Health sites, informed by strong Indigenous leadership, to 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 recruitment, and to facilitate NT participation in ongoing national reporting and streamlining activities; and work with comparable units in Queensland and Western Australia to establish a formal partnership arrangement to attract and support Northern Australia clinical trials, drawing on existing expertise in key research institutions and national clinical trials networks to inform and encourage high-quality national and international trials. 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 Northern Territory Clinical Trials Coordination Unit (NTCTCU), as a central point of contact for all clinical trial sponsors, researchers, coordinators and participants entering NT. Finalise agreement within NT Health on centralised functions of NTCTCU. Public launch of the NTCTCU website, including a single submission format and location for NT Clinical Trials and Human Research Ethics (HREC) applications. 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 NT Department of Health and two Health Services. Complete monitoring and evaluation activities to identify impact, effectiveness of, and revisions to, the NTCTCU, including coordination of the clinical trial pathway. 30 April 2018 30 April 2019 30 April 2020 30 April 2021 $241,043 $144,553 $144,553 $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) 2018-19, as agreed by the Clinical Trials Project Reference Group (CTPRG). Commence mapping of data extraction capability in the Core Clinical System Renewal Program (CCSRP), including capacity to collect 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. 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 the 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-Indigenous and Indigenous Australians. Completion of NTCTCU’s NT research needs assessment and evaluation, with recommendations for sustainable research structures that meet 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 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 the Northern Territory by __________________________________________ The Honourable Xxxxxxx Xxxxx MP Minister for Health / /2018

PROJECT MILESTONES, REPORTING AND PAYMENTS. In accordance with clause 12 of the Agreement, the Commonwealth and NT Queensland have agreed a Project Plan that sets out NTQueensland’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, NT Queensland 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 sponsors, investigators, referrers and patients; include liaison points within Queensland Academic Health Translation Centres to develop networked clinical trial sponsorshubs across multiple Hospital and Health Services (HSS); include a Clinical Trial Capability Project to measure Queensland’s baseline clinical trials capability, researchersincluding identification of under-represented clinical areas and current public-private partnerships, coordinators and participants 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 will: provide also maximises clinical trials resource utilisation and participation; and implement a single point of application for research ethics tele-trials model with satellite regional sites across Queensland, New South Wales and site specific approvals; provide a centralised source of advice and facilitate the introduction of standard operating procedures across all Northern Territory Department of Health sites, informed by strong Indigenous leadership, to 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 improve regional patient access to assist clinical trial recruitment, and to facilitate NT participation in ongoing national reporting and streamlining activities; and work with comparable units in Queensland and Western Australia to establish a formal partnership arrangement to attract and support Northern Australia clinical trials, drawing with an initial focus on existing expertise in key research institutions and national clinical trials networks to inform and encourage high-quality national and international trialsoncology. 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 publically launch the Northern Territory Clinical Trials Coordination Unit (NTCTCU)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, as a central point of contact for all and clinical trial sponsors, researchers, research coordinators to build workforce competency and participants entering NT. Finalise agreement within NT Health on centralised functions of NTCTCUcapability. Public launch of the NTCTCU websiteQCTCU, associated website and liaison points. Delivery of the Clinical Trial Capability Project, including a single submission format and location for NT Clinical Trials and Human Research Ethics (HREC) applications. Implement revised NT Health-wide research governance processes. Design and conduct publication of at least 100 clinical 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 site profiles on the NTCTCU and enter via QCTCU website to demonstrate 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 impact of the NT Department QCTCU on reducing the administrative load on clinical trial sites and approval timeframes. Delivery of Health and two Health Services. Complete monitoring and evaluation activities a Clinical Research Coordinator Workforce Strategy to identify impact, effectiveness of, and revisions to, the NTCTCU, including coordination of increase the clinical trial pathwayresearch 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 $241,043 428,520 $144,553 257,160 $144,553 257,160 $144,553 257,160 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) 20182017-1918, as agreed by the Clinical Trials Project Reference Group (CTPRG). Commence mapping ) Full contribution of data extraction capability in to the Core Clinical System Renewal Program (CCSRP)expanded NAS 2018-19, including capacity to collect total numbers of patients potentially eligible for trials. Finalise and implement an IT system for internal clinical trials management and external reportingas agreed by the CTPRG. 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. Establish Delivery of pilot oncology tele-trials / satellite site model across Queensland. Publication and maintain a Project Steering Committeemandating 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 include all NT stakeholders involved 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 research ethics and clinical annual performance report). Ongoing delivery of tele-trials governance processes. Deliver promotional activities to raise awareness of the 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-Indigenous and Indigenous Australians. Completion of NTCTCU’s NT research needs assessment and evaluation, with recommendations for sustainable research structures that meet population needsmodel. 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 the Northern Territory Queensland by __________________________________________ The Honourable Xxxxxxx 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 NT ACT have agreed a Project Plan that sets out NTACT’s strategy for delivering on the outputs of the Agreement. Consistent with the agreed Project Plan, NT ACT will consolidate and expand existing functions to establish the recently established state-wide ACT Centre for Clinical Trials (CCT) that will: act as a central point of contact (unit) for clinical trial sponsors, researchers, coordinators and participants that will: provide a single point of application for research ethics and site specific approvalsparticipants; provide a centralised source of advice and facilitate the introduction of standard operating procedures across all Northern Territory Department of Health sites, informed by strong Indigenous leadership, to support and encourage best practice and culturally appropriate research and recruitmentcoordination of all public sector clinical trials within ACT, including for vulnerable populationsdevelopment of streamlined mechanisms to enable New South Wales (NSW) residents to participate in ACT based trials; enhance clinical information systems develop and implement an innovative Information and Communication Technology (ICT) capability to assist platform that will enhance clinical trial recruitmentdata and recruitment capability, and to facilitate NT participation in ongoing national reporting and streamlining activitiessupport efficient translation of research outcomes into practice improvement; and work with comparable units in Queensland introduce a research mentorship program for new and Western Australia early career researchers to establish a formal partnership arrangement to attract enhance capability and support Northern Australia clinical trials, drawing on existing expertise in key research institutions and national clinical trials networks to inform and encourage high-quality national and international trialsactivity 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 Delivery of a project to inform system redesign and publically launch findings provided in annual performance report. Delivery of a 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 Northern Territory Clinical Trials Coordination Unit (NTCTCU), as a central point of contact for all clinical trial sponsors, researchers, coordinators ACT. Delivery and participants entering NT. Finalise agreement within NT Health on centralised functions of NTCTCU. Public public launch of the NTCTCU website, including a single submission format and location for NT Clinical Trials and Human Research Ethics Single Point of Contact (HREC) applications. Implement revised NT Health-wide research governance processes. Design and conduct trial of community consultations. Finalise and distribute a single Standard Operating Procedure (SOPSPC) for all clinical trials across NT Health sitesentering 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 in permanent clinical trial coordinator positions in ACT compared to baseline. Delivery of a new 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 strong Aboriginal leadershipreview outcomes. All NT Health Signed agreements with all ACT CCT partners to enable centralised management and coordination of 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 NT Department of Health and two Health Services. Complete monitoring and evaluation activities to identify impact, effectiveness of, and revisions to, the NTCTCU, including coordination of the clinical trial pathwayACT. 30 April 2018 30 April 2019 30 April 2020 30 April 2021 $241,043 255,237 $144,553 153,225 $144,553 153,225 $144,553 153,225 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) 20182017-1918, as agreed by the Clinical Trials Project Reference Group (CTPRG). Commence mapping 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 extraction capability in to the Core Clinical System Renewal Program (CCSRP)expanded NAS 2018-19, including capacity to collect total numbers as agreed by the CTPRG. Delivery of patients potentially eligible for trials. Finalise and implement an IT system for internal clinical trials management and external reportingbeta testing of innovative ICT system. Full contribution of data to the expanded NAS 2019-20, as agreed by the CTPRG. Capture all All clinical trials within reach of NTCTCU CCT captured within IT innovative ICT system. Full contribution of data to the expanded NAS 2020-21, as agreed by the CTPRG. Capture NAS data on recruitment as a proportion of all eligible patientsrequirements 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. Establish Signed agreement between ACT and maintain NSW to facilitate collaboration on development and operation of a Project Steering Committee, to include all NT stakeholders involved in shared research ethics and clinical trials governance processesinformation management system in partnership with NSW. Deliver promotional activities Signed Agreement between ACT and NSW to raise awareness streamline administrative functions and trial pathways to support cross-border trial participation, including to enable NSW regional residents to participate in ACT based trials. Signed agreement by ACT Health and the Xxxx Xxxxxx School of the NTCTCUMedical Research, ANU to facilitate translation of research into patient care and service improvement. 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-Indigenous and Indigenous Australians. Completion of NTCTCU’s NT research needs assessment and evaluation, with recommendations for sustainable research structures that meet population needs. 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 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 the Northern Australian Capital Territory by __________________________________________ The Honourable Xxxxxxx Xxxxx Xxxxxx Xxxxxxxxxx MP Minister for Health / /2018