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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
There are two ways unapproved therapeutic goods may be imported or supplied in Australia for use in a clinical trial:
- Clinical Trial Notification (CTN) scheme – a notification process whereby the Australian clinical trial sponsor notifies the Therapeutic Goods Administration (TGA) of the intent to sponsor a clinical trial involving an unapproved therapeutic good. The sponsor must complete an online form and pay a fee.
- Clinical Trial Exemption (CTX) scheme – an approval process whereby the Australian clinical sponsor applies to the TGA for approval to supply unapproved therapeutic goods in a clinical trial. The sponsor must submit a paper-based CTX application form and pay a fee.
Sponsors must ensure that all of the relevant approvals have been made before supplying the unapproved therapeutic goods in the clinical trial.
How robust are the standard good clinical practices followed in your jurisdiction?
The therapeutic goods legislation requires that the use of therapeutic goods in a clinical trial conducted under the CTN and CTX schemes accord with the following:
- the National Statement on Ethical Conduct in Human Research (2007), in accordance with the National Health and Medical Research Council Act 1992;
- the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials;
- the Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95), an internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines; and
- ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice.
The TGA also has clinical efficacy and safety guidelines on its website.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The endorsing Human Research Ethics Committee is responsible for monitoring clinical trials. Sections 3.3.19 to 3.3.22 of the National Statement on Ethical Conduct in Human Research and Chapter 5.5: Monitoring approved research set out the reporting and monitoring requirements. For example, sponsors must report serious adverse drug reactions, serious unexpected suspected adverse reactions and serious adverse device events (Section 3.3.20(b)(ii)).
The TGA also has the power to inspect clinical trial sites and search, examine, measure, record or document any information with respect to the trial (Regulation 12AC of the Therapeutic Goods Regulations 1990).
What are the informed consent obligations with respect to clinical trial subjects?
Chapter 2.2 of the national statement sets out the general requirements for consent. The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary and based on sufficient information and adequate understanding of both the proposed research and the implications of participation (Section 2.2.1).
What are the insurance requirements for clinical trials?
Institutions must be satisfied that trial sponsors have made the indemnity or insurance and compensation arrangements required by:
- the Note for Guidance on Good Clinical Practice of the Committee for Proprietary Medicinal Products and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (CPMP/ICH) (CPMP/ICH-135/95);
- ISO 14155 Clinical Investigation of Medical Devices; and
- the TGA (Section 3.3.24 of the national statement).
Institutions must also have arrangements to compensate participants for harm resulting from negligence in research (Section 3.3.25 of the national statement).
What data protection issues should be considered when conducting clinical trials?
Researchers’ use of data from databanks must comply with conditions specified by the providers of the data researchers (Section 3.2.3 of the National Statement).
Researchers must also ensure that the use of personal information complies with the Privacy Act 1988.
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