Resources for the National Clinical Trials Governance Framework
The Australian Commission on Safety and Quality in Health Care (the Commission) has developed resources for health services to support implementation of the National Clinical Trials Governance Framework (Governance Framework).
National Clinical Trials Governance Framework FAQs and fact sheets
These fact sheets explain the National Safety and Quality Health Service (NSQHS) Clinical Governance Standard Partnering with Consumers Standard and identify the roles and functions of the governing body, managers (clinical and non-clinical), principal investigators, clinical trials workforce, accrediting agencies and consumers.
The Clinical Trials Portal
The Commission has developed the following web-based tools to assist health services monitor their clinical trial service operations and self-assess their capacity to meet the actions within the NSQHS Standards, as provided in the Governance Framework:
- The self-assessment tool
- The operational metrics tool.
The Commission conducted a series of webinars to support health services navigate the Clinical Trials Portal.
This self-assessment tool assists health services assess their capacity to meet the actions in the Governance Framework. The tool enables health services to:
- Determine whether they meet the actions
- Document the evidence that demonstrates each action has been met
- Create an action plan of any tasks to meet the actions, including allocating a person responsible for completing the tasks.
Actions within the Governance Framework are aligned with the NSQHS Clinical Governance Standard and Partnering with Consumers Standard. Speak with your hospital quality officer about the systems and processes currently in place to meet the actions within the NSQHS Standards and use the tool to assess your clinical trial service.
Operational metrics tool
The operational metrics tool enables the workforce within trial units, clinical departments, hospitals and health networks to report on their clinical trial service operations. This information enables health service organisations to review their clinical trial services operating in multiple departments using a series of automated reports.
The operational metrics tool is aligned with the reporting requirements for the National Aggregate Statistics (NAS).
Privacy of information
All information provided by registrants is kept strictly confidential. The information is held electronically in restricted access files.
Support and communication
The Commission will continue to provide advice to health services on implementation of the Governance Framework through the Safety and Quality Advice Centre.
Please direct your enquiries to the AdviceCentre@safetyandquality.gov.au or phone 1800 304 056.