Australia’s clinical trials environment is complex, with various responsibilities resting with institutions, private organisations and companies, State or Territory Governments and the Commonwealth Government.
Below are a selection of resources that may be useful when conducting a clinical trial in Australia.
Legislation, Regulations and Guidelines
There are a number of Commonwealth legislation, regulations and guidelines to be considered when conducting a clinical trial in Australia. The resources listed below may be helpful in the first instance.
- The Therapeutic Goods Act 1989 (Cth) (TG Act)
- The Therapeutic Goods Regulations 1990 (Cth)
- Therapeutic Goods Administration (TGA) clinical trials website
- The Australian Clinical Trial Handbook
- The National Statement on Ethical Conduct in Human Research
- The Australian Code for the Responsible Conduct of Human Research
- Guidance for Good Clinical Practice – ICH GCP (Annotated by TGA)
- Privacy Act 1988 (Cth) (note: most States and Territories have their own privacy laws and law protecting medical records)
- Information regarding health privacy
- Embryo Research Licensing Legislation
- Consent and Guardianship Laws in Australia
- NHMRC’s eLearning module: Clinical Trials Environment in Australia
- Data retention, storage, disposal and archiving
- Clinical investigation of medical devices for human subjects - ISO14155
Note: the above list of laws and resources is indicative only.
Trial – start up
The information below may be helpful when planning a clinical trial.
Why conduct a clinical trial in Australia?
Site capability, feasibility and authorisation
- Clinical Trial Capability Report (AusTrade)
- Site capability list
- Report on Clinical Trial Network activity (see Appendix E for a list of networks)
- Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance
- Site Specific Assessment
- Research Governance related to Clinical Trials - NHMRC eLearning module
- SPIRIT Statement and Checklist
Ethical considerations
- Human Research Ethics Application
- National Statement on Ethical Conduct in Human Research
- Ethics review - NHMRC eLearning module
- Single Review in Australia
- NHMRC Certified Institutions
- NHMRC registered HRECs
- Ethical guidelines for research involving Aboriginal and Torres Strait Islander Peoples
- Guidelines for Ethical Research in Australian Indigenous Studies
- Ethical Guidelines on the use of Assisted Reproductive Technology in clinical practice and research
- Participant Information and Consent Forms
Trial registration
- About trial registration
- Australia New Zealand Clinical Trials Registry
- ClinicalTrials.gov (US-based registry)
- International Committee of Medical Journal Editors – Policy on Trial Registration
Forms, fees & other resources
- NHMRC eLearning Modules
- Determination of standard costs associated with conducting clinical trials in Australia
- TGA FAQs on CTN online submissions and the clinical trials schemes
- TGA Fees and charges
- Medicines Australia Clinical Trials Research Agreements
- Medicines Australia indemnity forms
- Medicines Australia – information on clinical trials
- Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia (NHMRC)
- Clinical Research Organisations/Networks (Australian Clinical Trials Alliance)
- National Health and Medical Research Council Grants and Funding (NHMRC)
- Australian Research Council (ARC)
- Research and Development (R&D) Tax Incentive Grants & Assistance (AusIndustry)
- Research and development tax incentive – Australian Tax Office
- Australian Competitive Grants Register
Trial - First participant to finish
The information below may be helpful once the clinical trial has commenced.
Research monitoring
- Australian Code for the Responsible Conduct of Human Research
- Safety monitoring guidance
- TGA advice on reporting and safety monitoring
- Data retention, storage and disposal See Part A of the 2007 - Australian Code for the Responsible Conduct of Human Research
- Annual reporting (Section 5: National Statement on Ethical Conduct in Human Research)
The report
Closing the trial
Publishing results
- The requirement to report clinical trials as per the new World Health Assembly (WHA) resolution on clinical trials
- The importance of publishing results
- NHMRC Open Access Policy
- Australian Code for the Responsible Conduct of Human Research
- NHMRC Statement: Support of the principles behind the Alltrials campaign
Submitting a report to a marketing authorisation body
Post completion
State and Territory resources
Each State and Territory has different legislation or guidance material. Below is an overview of some of the key information that can differ from each State and Territory.
- Australian State and Territory privacy laws
- Ethical review process for each Australian State and Territory
- The National Mutual Acceptance Scheme (New South Wales, Victoria, Queensland, Australian Capital Territory and South Australia)
- Insurance and indemnity FAQs
- Consent and Guardianship Laws in Australia
Australian Tele-Trial Model
The Australasian Tele-Trial Model was developed by the regional and rural group of COSA and uses tele-health to facilitate clinical trial activity. The purpose of the Model is to increase access to clinical trials for people with cancer living in rural and remote locations, although the benefits are not limited to this as it could also be utilised for patients with rare and less common cancers in metropolitan areas. COSA has led a MTPConnect funded project to pilot the Model over the last two years and the Model has now been implemented at sites in Queensland, NSW and Victoria. There is significant interest and support for the Model from industry sponsors and investigator groups.
COSA have developed a range of resources to support the implementation of the Tele-Trial Model for sponsors and sites. The Tele-Trials resources webpage also provides links to other resources developed in Queensland, NSW and Victoria to support the Tele-Trial Model.