Pilot of the National Clinical Trials Governance Framework

The Pilot implementation of the Governance Framework is now closed, however you may continue to use the Clinical Trials Portal.

The Commission is currently collating all data and information gathered through the pilot. Consolidated findings will assist in the refinement of the Governance Framework and supporting resources ahead of implementation from January 2022.

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

The Commission conducted a series of webinars to support health services navigate the Clinical Trial Portal. Access the webinar via the following link: A guide to the Clinical Trials Portal and web-based tools.

A user guide and a list of Frequently Asked Questions have also been developed to assist with navigating through the tools including the registration process.

Self-assessment tool

The self-assessment tool assists 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).

Privacy of information 

All information provided by registrants is kept strictly confidential. The information is held electronically in restricted access files. 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 Doriane Ranaivoharison on (02) 9126 3647. Alternatively, you can contact a member of the Clinical Trials team via email on HMR@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.

In November 2019, all Australian Health Ministers agreed for the Commission to undertake a pilot of the Governance Framework in health service organisations currently accredited to the NSQHS Standards that conduct clinical trials.

The Governance Framework builds on the National Model Clinical Governance Framework and the 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 was 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 was conducted via two levels of health service participation.

Level 1 – Voluntary approach

All health service organisations could provide voluntary feedback  on the Governance Framework and the supporting tools and resources. 

Level 2 – Targeted approach

Level 2 pilot sites consisted of 14 pilot sites:

• Alfred Health (The Alfred)
• 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 (Royal Prince Alfred Hospital)
• 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 were 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 were 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 the pilot survey to provide feedback on the Governance Framework
• Participate in a (remote) accreditation assessment
• Participate in a post-pilot workshop.