Pilot of the National Clinical Trials Governance Framework

Register with the Commission to access 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 National Safety and Quality Health Service (NSQHS) Standards, as provided in the Governance Framework:

• The self-assessment tool
• The operational metrics tool

Access the Clinical Trials Portal here

A user guide has also been developed to assist with navigating through the tools including the registration process.

Self-assessment tool

The self-assessment tool will assist health service organisations 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 Standards 1 and 2. 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. The collected information enables health service organisations to review their clinical trial services operating in multiple departments using a series of automated reports.

The operational report items are aligned with the National Aggregate Statistics (NAS).

The operational metrics tool and the self assessment tool will continue to be available following the pilot. You may continue to use the reports generated by these tools to assist with with strategic planning to deliver clinical trial services. 

Pilot survey

The pilot survey will enable the Commission to evaluate the Governance Framework pilot. Complete the pilot survey to provide feedback on the Governance Framework and supporting resources.

Privacy of information submitted from pilot sites

All information provided by registrants will be kept strictly confidential. The information will be held electronically in restricted access files. The information collected will only be used by the Commission to inform the pilot of the Governance Framework. No information will be reported that might identify a health service organisation without their permission. The Commission is bound by its privacy policy: http://www.safetyandquality.gov.au/about-us/governance/privacy-policy/

Support and communication

If you have any questions regarding access and/or registration to the clinical trials portal, please call either Doriane Ranaivoharison on (02) 9126 3647 or Courtney Brown on (02) 9126  3533. Alternatively, you can contact a member of the Clinical Trials team via email on CTgovernance@safetyandquality.gov.au

National Clinical Trials Governance Framework pilot  - Overview

Development of the National Clinical Trials Governance Framework is underpinned by a Literature Review and Mapping Exercise of national regulation and legislation and jurisdictional legislation, polices and processes with which clinical trials must comply.

An expert Steering Committee advised on the development of the Governance Framework, and feedback received through national sector wide consultation has contributed to finalising the draft, now agreed by COAG Health Council, to undergo further review through a national pilot.

The Governance Framework builds on the National Model Clinical Governance Framework and the National Safety and Quality Health Service (NSQHS) Standards, providing:

• The roles and functions for identified positions relating to clinical trial service provision within a health service organisation
• Actions against which health service organisations with a clinical trial service will be assessed for accreditation
• Suggested strategies health services may implement to meet the actions within the NSQHS Standards
• Examples of evidence a health service organisation may provide that demonstrate they have met the actions within the NSQHS Standards for clinical trial service provision. 

The Governance Framework is based on the Commission’s existing NSQHS Standards for hospital and day procedure service accreditation, in particular, Standard 1: Clinical Governance Standard and Standard 2: Partnering with Consumers Standard. The Governance Framework describes the actions that are essential for health service organisations to achieve integrated corporate and clinical governance systems for clinical trial service delivery.

The purpose of the pilot is to ensure:

• Health service organisations  conducting clinical trials understand the intent of the Governance Framework (Standards 1 and 2)
• The Governance Framework enables health service organisations to identify and address gaps in safety and quality of clinical trial service provision
• The structure, sequence and format of the Governance Framework is logical and easily understood
• The language on the intent of the Governance Framework is specific and clear
• The Governance Framework can be implemented by health service organisations providing clinical trials and assessed for compliance to the actions within NSQHS Standards 1 and 2
• Identification of additional resources that may be required to support national implementation of the Governance Framework.

The pilot is being conducted via two levels of health service participation.

Level 1 – Voluntary approach

All health service organisations can participate as a Level 1 pilot site and provide voluntary feedback via an on-line survey on the Governance Framework and the supporting tools and resources. Using the web-based self-assessment tool, health service organisations may assess their ability to meet the requirements of the Governance Framework and respond to a pilot survey. Feedback on other resources, such as the operational metrics tool, the video tutorial and fact sheets may also be provided to the Commission on a voluntary basis.

Level 2 – Targeted approach

Level 2 pilot sites consist of 14 pilot sites:

• Alfred Health
• Canberra Hospital
• Orange Heath Service
• Perth Children's Hospital
• Ramsay Health Care (14 health services)
• Royal Adelaide and Queen Elizabeth Hospitals
• Royal Brisbane and Women's Hospital
• Royal Darwin Hospital
• Royal Hobart Hospital
• St Vincent’s Health Network, Sydney and Melbourne
• Sydney Local Health District
• The Royal Victorian Eye and Ear Hospital
• Townsville Hospital and Health Service
• Victorian Clinical Trial Research Support Service (Ballarat Health, Barwon Health, Bendigo Health, Goulburn Valley Health and Northeast Health Wangaratta)

Sites have been selected from each jurisdiction based on the following criteria: geographic location, positioning within a local health district, health service specialisations, demographics and public/private facility.

Selected sites are required to:

• Undertake a gap analysis using the web-based self-assessment tool
• Report and review information relating to clinical trial operations via the operational metrics tool
• Respond to a pilot survey to provide feedback on the Governance Framework
• Participate in a (remote) accreditation assessment conducted by the Institute for Healthy Communities Australia (IHCA) accrediting agency
• Participate in a post-pilot workshop.

All health service organisations are invited to participate as a Level 1 pilot site and provide voluntary feedback via an on-line survey on the Governance Framework and the supporting tools and resources.