To support the delivery of high-quality clinical trial services the Australian Commission on Safety and Quality in Health Care (the Commission) has developed the National Clinical Trials Governance Framework (Governance Framework) on behalf of all jurisdictions in collaboration with the Australian Government Department of Health.

The Governance Framework provides the first step toward the accreditation of health services for the conduct of clinical trials service delivery. The Commission has developed the Clinical Trials portal to support health service organisations with implementation of the Governance Framework within their local service context.

Self-assessment tool

The self-assessment tool assists health service organisations assess their own capacity to meet the actions in the Governance Framework (where applicable), identify gaps and track their progress. The tool allows health service organisations to:

Determine whether they meet the requirements of the actions (where applicable)
Create a local action plan of any tasks that are needed to meet the action, including identifying roles and allocating responsibilities within the health service organisation.

Operational metrics tool

The operational metrics tool will support trial units, clinical departments, hospitals and health networks to collect and review their clinical trial service operational performance through a series of automated reports. These reports can be used to assist your health service organisation with strategic planning to deliver a clinical trial service. The operational reports items are aligned with the National Aggregate Statistics (NAS).

Guidance

For help navigating the Clinical Trials portal, you can access the Clinical Trials portal user guide here.

Resources to support health services with implementation of the Governance Framework including fact sheets, flow charts and case studies are available here.

The Commission are currently scoping the requirements to support a re-design of the clinical trials portal. At this time, users will not be able to upload evidence to demonstrate that an individual action if the Governance Framework has been met (where applicable). Alternatively, users are advised to input data in reference to the location where these documents are stored within the health service and retain copies in a safe and secure location which can be produced as example evidence in the instance of an accreditation assessment.

Any queries, including user feedback, can be directed to the Health and Medical Research team via email at hmr@safetyandquality.gov.au.

For more information about the Commissions privacy practices see our Privacy Policy.

Please register to access our site

I am registering as a

Site administrator

Site contributor

*As a Site administrator, you have oversight of the clinical trials portal for your health service organisation. You can invite and verify site contributors within your health organisation. To register as a site administrator, you need written proof of your delegation by your Chief Executive.

* Register as a Site contributor if you are a general user.

Email address

A professional email address is required to register.

What is your current role within your organisation?

In which clinical department do you work?

We recommend that you select all the clinical departments you are involved in within your health service organisation. If you are registering as a site administrator, select all the clinical departments in your health service organisation in which clinical trials are conducted.

The Australian Commission on Safety and Quality in Health Care (the Commission) collects personal information when the information is necessary for, or directly related to, the Commission’s functions or activities. Your personal information is being requested for the Commission to fulfil its purpose under legislation. The personal information is required in order for the Commission to administer and manage the online clinical trials self-assessment and operational tools. If you do not provide the requested personal information, the Commission may not be able to process your registration further. All personal information is held securely. The Commission treats all personal information in accordance with the Australian Privacy Principles under the Privacy Act 1988 (the Act) and the Commission’s Privacy Policy. The Commission does not disclose personal information to other organisations unless it is required to do so under the Australian law or tribunal/court order. The Commission’s Privacy Policy is available from the Commission’s website at www.safetyandquality.gov.au.

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