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National One Stop Shop for Health Research Project – ICT Solution
The National One Stop Shop ICT solution effectively joins up the clinical trial and health research whole-of-life cycle into one operational system (from approval, registration and conduct through to the publication of results) supported by mutually agreed processes and policies. The National One Stop Shop includes:
- A cross-jurisdictional ethics approval and site-specific authorization platform that incorporates key application, notification and approval processes.
- The Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration (TGA) and processes required by the Gene Technology Regulator.
- An embedded and automated next-generation national registry with APIs to external data sources.
- Research management functionality with monitoring and reporting functionality for different users (including but not limited to, project and participant visit management, financial-tracking and reconciliation, safety and adverse event reporting and annual HREC reporting) and automated data/reports/processes to support the accreditation process and other ad hoc reporting requirements.
- A national website with search functionality to enable the community to search and filter information on clinical trials and health research relevant to them and register their interest to receive system enabled notifications.
The National One Stop Shop ICT Solution provides a single nationally consistent and harmonised ICT solution for the approval and management of clinical trials and health-related research underpinned by the principles of ‘information entered once, used multiple times and ‘the system will enable all data to be reported against.’
The solution has high fault tolerance and scalability that allows for the adoption of changes to existing and new workflows; information sharing; profile creation; document management; internal system enabled user communication and collaboration; visibility of the approval and research management process, date stamped with automated data and reporting for various users.
The Respondent must not have had any judicial decisions against it (excluding decisions under appeal) relating to employee entitlements and have not paid the claim.
The Respondent, its personnel, and any Subcontractors proposed in the Submission must not, at the Closing Time, be listed as terrorists under section 15 of the Charter of the United Nations Act 1945 (Cth). The Respondent (and any Subcontractor proposed in its Submission) must not be named in the Consolidated list referred to in Regulation 40 the Charter of United Nations (Dealing with Assets) Regulations 2008 (Cth).
24 months following a subsequent tender process, should this proceed.
AusTender at www.tenders.gov.au in accordance with instructions in the Request documentation.