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  8. Clinical Trials

Clinical Trials

Overview

What is the 'clinical trial' section in the UC HREC application and why is it important?

Information in the “Clinical Trial” section of your HREC application is required so the UC HREC can assess details relevant to the insurance coverage for your clinical trial. It is important to note that HREC applications without the “Clinical Trial” section completed are not covered under UC HREC insurance.

Who decides whether the proposed research is a clinical trial??

It is the researcher’s responsibility to determine whether the human research they propose to conduct under UC HREC approval meets the definition of a clinical trial.

What is considered a clinical trial for the purpose of a UC HREC application?

We acknowledge that there is no uniform definition of a clinical trial. For the purpose of a UC HREC application, a clinical trial is defined as:

  • Any human trial or health volunteer study that complies with the statutory requirements or guidelines of the relevant authority, department, or registered public/private body in the country where the trial or study takes place; or
  • Any study that must be approved by UC HREC as a clinical trial.

This includes clinical trials in Australia and most overseas locations.

Applicable to Australia, this definition includes clinical trials regulated under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes, in accordance with the Therapeutic Goods Administration (TGA) definition below.

  • Clinical trials in Australia using "unapproved therapeutic goods", that is, goods which have not been evaluated by the TGA for quality, safety and efficacy and are not entered into the (ARTG) for general marketing, are required to make use of the CTN or CTA schemes.
  • The definition of an 'unapproved' good can encompass many aspects of a product, such as formulation, dose form, name, indications, directions for use and container. Therefore, even if a product is listed in the ARTG, it may still require an exemption under the CTN or CTA schemes for use in a clinical trial. For example, the product might be used for a different indication, at a higher dosage than approved for marketing, or sourced from a foreign market.

Please provide all relevant information for all locations where the trial or study takes place, including any overseas clinical trials submitted to the UC HREC for review.

Information regarding the insurance of clinical trials submitted to UC HREC for review

  1. You are responsible for seeking your own legal advice and for understanding all laws and regulations in the country where you plan to conduct the trial.
  2. Please note that certain clinical trials may be excluded from the scope of UC HREC insurance. Once we receive your application, we will contact you if your proposed clinical trial cannot be covered. In such cases, the researcher must arrange appropriate insurance before the trial can be approved.
  3. While the UC clinical trials insurance policy provides coverage in most overseas countries, some countries may require a local insurance policy with a local insurer. If a local policy is obtained, the UC insurance will act as additional cover in excess of the local policy.

What else does a Researcher need to know about insurance?

As stated on the , 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 trials of medicines, biologicals and medical devices conducted in Australia are subject to Commonwealth Government regulation administered by TGA. For full details, refer to the TGA website:

Refer to the for more information on the 2014 review of insurance and indemnity arrangements in Australia.

Clinical Trial Requirements

1. All clinical trials must be conducted in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH135/95 – Annotated with TGA Comments) and the Good Clinical Practice (GCP) guidelines adopted in Australia. GCP is an international ethical and scientific standard for designing, conducting, recording, and reporting trials that involve human participants.

2. When applying to the University’s Human Research Ethics Committee (HREC), all clinical trials must be clearly identified and the “Clinical Trial” box must be ticked in Section 1 of the HREC Application Form.

3. Section 3 of the HREC Application Form must be completed.

4. The Participant Information and Consent Form must clearly state that the proposed project is a clinical trial and provide clear and concise information about the trial’s purpose, benefits, methods and instruments, participant involvement, risks, sponsors, confidentiality, withdrawal rights, data storage, and contact details, including those of the Research Ethics & Integrity Unit.

5. Data collected during UC-approved clinical trials must be stored for at least 15 years on password-protected and secure UC computers and/or premises.

6. Clinical trials cannot be registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) unless full approval has been received from the University’s HREC. A link to the registration page must be provided to the HREC as soon as the trial registration has been finalised.

7. If approval has been received from another Ethics Committee (such as the ACT Health Ethics Committee), cross-institutional approval must be applied for and received before registering with the ANZCTR.

8. Applicants are required to register a clinical trial in a publicly accessible trials registry prior to the enrolment of the first participant, as a condition of ethics approval.

9. Please note that UC’s HREC requires a progress report at least twice per year during the approval period.

A-CTEC Clinical Trial Training Courses:

NEW GCP Refresher Course (ICH E6R3) Now Available -

Updated Comprehensive Trials Essential Packages (ICH E6R3 included) - For Investigators  

Updated Comprehensive Trials Essential Packages (ICH E6R3 included) - For Research Team

Further resources relating to clinical trials can be found here