Principles, regulations and governance of clinical trials

Learn about the laws, regulations and guidelines that govern clinical trials in Australia. Institutions that oversee research must also comply with governance principles.

Research principles and guidelines

In Australia, all research involving humans must comply with national ethics guidelines, laws and codes of conduct. Learn more about the standards that govern clinical trials in Australia.

The regulatory environment

Australian legislation covering the use of therapeutic goods includes the:

Clinical trials of unapproved therapeutic goods

Guidance on conducting clinical trials in Australia using unapproved therapeutic goods can be found in the Australian clinical trial handbook.

The following avenues provide for the importation into or supply in Australia of unapproved therapeutic goods for use in a clinical trial:

  • Clinical Trial Notification (CTN) scheme
  • Clinical Trial Approval (CTA) scheme.

Clinical trials that do not involve unapproved therapeutic goods are not subject to requirements of the CTN or CTA schemes.

Learn more about these schemes on the Therapeutic Goods Administration's (TGA’s) website.

Ethics approvals

All proposals to conduct clinical trials in Australia require ethics review and approval, most commonly by a human research ethics committee (HREC).

An HREC must register with the National Health and Medical Research Council (NHMRC) and provide assurances that it is operating within NHMRC guidelines.

Find out more about HRECs, including how to apply for an ethics review, on the NHMRC’s website.

In addition to ethics approval, sites where clinical trials are conducted must also authorise the research for their site.

More guidance on regulatory requirements for clinical trials in Australia is available in the TGA’s Australian clinical trial handbook.

Research governance

Institutions are accountable for research projects they oversee. Research must be done in line with:

  • established ethical principles
  • guidelines for responsible research conduct
  • relevant legislation and regulations
  • institutional policy.

Research governance is also about credentialing and training of researchers, and managing institutional risk.

Elements of research governance include:

  • ethical approval
  • compliance with legislation, regulations, guidelines and codes of practice
  • legal matters, including contracts, and indemnity or insurance frameworks
  • financial management, risk management and site-specific assessment
  • institutional policies and procedures for responsible research conduct and managing research misconduct
  • management of collaborative research
  • reporting requirements.

More information on research governance is available in the National Clinical Trials Governance Framework.

Site-specific assessment

All public and private health organisations must undertake a site-specific assessment (SSA) of each research project. This allows the organisation to consider whether:

  • the project is suitable for the site
  • it has the capacity to conduct the research at that site.

The SSA considers physical resources, staff, insurance and indemnity requirements and other matters.

More information on SSAs is available:

Clinical trial agreements

All parties involved in the research of medicines and medical devices must have an agreement between all parties. Jurisdictions together with Medicines Australia developed agreement templates which are available on the Medicines Australia website.

You can also arrange for indemnity for your research institution, ethics committee or research premises.

For medicines research, Medicines Australia have standard templates for clinical trial agreements, contracts and indemnities.

For medical device research, use the templates on the Medical Technology Association of Australia website.

Insurance and indemnity

Reaching agreement on insurance and indemnity arrangements is a key step in the clinical trial approval pathway. You need to understand how insurance and indemnity policies work in relation to your research. Rules vary between institutions and jurisdictions.

Clinical quality registries

Clinical quality registries collect data on the quality of health care provided to patients who use healthcare resources to improve the quality of the healthcare system.

Clinical quality registers provide data to jurisdictions, healthcare providers, clinicians, researchers and others to:

  • set clinical performance benchmarks
  • identify where there are significant variations in health outcomes
  • develop evidence-based clinical guidelines and standards.

Find more information about clinical quality registries on the:

Date last updated:
  • Running clinical trials