Common use of PROJECT OUTPUT Clause in Contracts

PROJECT OUTPUT. Output 8. The output of this Agreement will be the redesign of clinical trials systems through: (a) establishing new and enhanced central coordination units or equivalent that will: i. play a key ‘gateway’ role for sponsors, investigators, referrers and participants accessing and navigating trials; ii. reduce the administrative load on trial sites through the provision and/or facilitation of key trial operational functions (e.g., feasibility assessment, ethics clearance, site authorisation, trial governance, insurance and contract management); iii. act as central points for communication, training and education; iv. support patient recruitment and the conduct of clinical trials; v. support the clinical trial workforce through building capacity and capability, ensuring quality control and pooling resources to provide career pathways and professional development; and vi. work across jurisdictions towards a consistent and cohesive national approach to the conduct of clinical trials, including implementing agreed standards; (b) implementing new and enhanced clinical trial data collection and reporting to inform systems improvement with interoperability and data flow capability, and contribute to better sector knowledge, recruitment and overall sector performance including through: i. implementation and continued expansion of clinical trials metrics collection including those agreed under the Framework for National Aggregate Statistics (NAS); and ii. ongoing submission of agreed metrics to the national data collection in accordance with the Framework for NAS; (c) establishing and maintaining new networks and partnerships within and between jurisdictions, clinical trial networks, communities of practice (eg. oncology, working with ATSI groups) and registries; and (d) embedding research and clinical trials processes into core hospital governance arrangements. 9. The States are collectively responsible for delivering these outputs, which reflect the revitalised clinical trials agenda endorsed by Health Ministers in March 2017. In support of these outputs, each jurisdiction is responsible for delivering the projects agreed in its bilateral Schedule to this Agreement.

PROJECT OUTPUT. Output 8. The output of this Agreement will be the redesign of clinical trials systems through: (a) establishing new and enhanced central coordination units or equivalent that will: i. play a key ‘gateway’ role for sponsors, investigators, referrers and participants accessing and navigating trials; ii. reduce the administrative load on trial sites through the provision and/or facilitation of key trial operational functions (e.g., feasibility assessment, ethics clearance, site authorisation, trial governance, insurance and contract management); iii. act as central points for communication, training and education; iv. support patient recruitment and the conduct of clinical trials; v. support the clinical trial workforce through building capacity and capability, ensuring quality control and pooling resources to provide career pathways and professional development; and vi. work across jurisdictions towards a consistent and cohesive national approach to the conduct of clinical trials, including implementing agreed standards; (b) implementing new and enhanced clinical trial data collection and reporting to inform systems improvement with interoperability and data flow capability, and contribute to better sector knowledge, recruitment and overall sector performance including through: i. implementation and continued expansion of clinical trials metrics collection including those agreed under the Framework for National Aggregate Statistics (NAS); and ii. ongoing submission of agreed metrics to the national data collection in accordance with the Framework for NAS; (c) establishing and maintaining new networks and partnerships within and between jurisdictions, clinical trial networks, communities of practice (eg. oncology, working with ATSI groups) and registries; and (d) embedding research and clinical trials processes into core hospital governance arrangements. 9. The States are collectively responsible for delivering these outputs, which reflect the revitalised clinical trials agenda endorsed by Health Ministers in March 2017. In support of these outputs, each jurisdiction is responsible for delivering the projects agreed in its bilateral Schedule to this Agreement. Project Agreement for Encouraging More Clinical Trials in Australia PART 3 — ROLES AND RESPONSIBILITIES OF EACH PARTY 10. The Commonwealth will be responsible for: (a) monitoring and assessing achievement against milestones in the implementation of this Agreement to ensure that outputs are delivered within the agreed timeframe; and (b) providing a consequent financial contribution to the States to support the implementation of this Agreement. 11. The States will be responsible for: (a) all aspects of delivering on the project outputs set out in this Agreement; (b) developing Project Plans in consultation with the Commonwealth and in accordance with clauses 12 and 13 of this Agreement; and (c) reporting on the delivery of outputs as set out in Part 4 – Project Milestones, Reporting and Payments and the schedules to this Agreement. 12. The Commonwealth and the States will be responsible for: (a) developing and agreeing bilateral schedules to this Agreement which set out milestones, reporting and payment arrangements in accordance with Part 4 – Project Milestones, Reporting and Payments; (b) agreeing Project Plans in accordance with clauses 11 and 13 of this Agreement; (c) working with the Australian Commission on Safety and Quality in Healthcare (ACSQHC) to develop a governance framework for clinical trials in public hospitals to ensure governance processes are robust and meet appropriate standards; and (d) meeting the requirements of Schedule E, Clause 26 of the IGA FFR, by ensuring that prior agreement is reached on the nature and content of any events, announcements, promotional material or publicity relating to activities under this Agreement, and that the roles of both Parties will be acknowledged and recognised appropriately.