National Clinical Trials Governance Framework

The Governance Framework embeds clinical trial services into the routine provision of health services. It strengthens governance for clinical trials, provides clarity to those who deliver them, and helps to drive national consistency.

About service accreditation

All hospitals and day procedure services go through independent accreditation to ensure they comply with the National Safety and Quality Health Service (NSQHS) Standards.   

Assessors can assess a health service for clinical, corporate and clinical trial services all at the same time. 

About the Governance Framework

The National Clinical Trials Governance Framework provides the actions specific to clinical trial services as part of the:

Organisations that run clinical trials need to comply with these actions.

The Governance Framework helps them meet this requirement by:

  • suggesting strategies that health services may implement
  • providing examples of evidence that services may provide assessors
  • describing the roles and functions of staff members who work on clinical trials.

This embeds clinical trials into the routine provision of health services and their governance, ensuring they are safe and of high quality.

Why it is important

National consistency in clinical trials is a key reform initiative to improve the health and medical research operating environment.

Improving the operating environment will position Australia as a leading destination for research – providing more Australians with access to emerging treatments.

Clinical trials conducted in a safe environment and in a high-quality manner improves health outcomes.

The Governance Framework helps:

  • reduce trial start-up times
  • speed up pre-approval and participant recruitment timeframes
  • engage trial sponsors
  • improve consistency in trial service delivery.

It ensures that health services:

  • run clinical trials consistently and safely
  • consider clinical trials as core health service business
  • embed clinical trials governance in their corporate governance of organisational systems and processes
  • embed clinical trials in their clinical governance systems.

Who we work with

We work with:

  • health services to help them understand their responsibilities and prepare for assessments, including through information sessions and resources
  • the Australian Commission on Safety and Quality in Health Care to help assessors understand their role in assessing health services conducting clinical trials.

Status

Assessors currently use the maturity scale to assess health services conducting clinical trials. They rate the services as having ‘established’, ‘growing’ or ‘initial’ systems in place to meet the NSQHS Standards.

As the policy owner, we intend to evaluate the implementation of the Governance Framework and consider opportunities for further improvement.

Learn more

See resources to support health services.

Date last updated:
Tags:
  • About clinical trials