Clinical Trial Registration
The National Statement on Ethical Conduct in Human Research, Section 3.1.7, advises “For any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes, researchers must register the project as a clinical trial on a publicly accessible register complying with international standards (see information on the International Clinical Trials Registry Platform (ICTRP) on the World Health Organisation website) before the recruitment of the first participant.”
Therefore, as a condition of ethics approval all research involving a clinical trial must be registered on a publicly accessible register before the recruitment of the first participant.
ECU recommends registration with either the Australian New Zealand Clinical Trials Registry (ANZCTR).
If you would like to discuss the use of another Primary Registry, please contact researchgovernance@ecu.edu.au.
Therapeutic Good Authority - CTN/CTA Scheme
Does your clinical trial involve the use of unapproved therapeutic goods (ie: drugs, medical devices or biologicals)?
If so, the project is subject to additional national laws and regulations including:
- The Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods Regulations 1990
The TGA Act and Regulations establish two schemes for clinical trials involving therapeutic goods that have not received approval for supply in Australia (i.e. they are ‘unapproved’), these are:
- The Clinical Trials Notification (CTN) scheme, and
- The Clinical Trials Approval (CTA) (previously referred to as CTX) scheme
Clinical trials that do not involve the use of an ‘unapproved’ therapeutic goods do not need to be registered as a CTN or CTA, however HREC approval and ANZCTR registration is required prior to commencement of the research.
CTN or CTA?
The CTN scheme is a notification of a clinical trial involving an ‘unapproved’ therapeutic good. A CTN can be submitted where the level of risk is such that ECU’s HREC can review the scientific validity of the trial design and assesses the safety of the product/trial. The CTN scheme simply requires the sponsor to notify the TGA once certain approvals like ethics approval have been obtained and to pay a notification fee. The TGA does not review the clinical trial. Rather, this is left to the HREC of an institution conducting the research.
The CTA scheme is approval by the TGA of a clinical trial involving an ‘unapproved’ therapeutic good, where the level of risk is higher than that of a CTN scheme project and where the institutions HREC does not have sufficient technical and/or scientific expertise to adequately assess the safety of the product. The TGA will evaluate the project and undertake scientific review prior to the institution’s HREC review and approval of the project.
Applications for both CTN and CTA schemes are submitted by ECU Research Governance on behalf of the Chief Investigator. The Research Governance Team can provide further advice regarding this requirement and the information required for the application.
TGA Sponsorship of a Clinical Trial
The TGA requires all clinical trials conducted in Australia which are subject to the CTN or CTA schemes to have a trial sponsor. The trial sponsor is responsible for initiation, management, monitoring and financing (or arranging financing) of the trial. Further details regarding these responsibilities are outlined in the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2), as annotated by the Therapeutic Goods Administration.
To request ECU’s sponsorship of the clinical trial you will need to complete the Clinical Trial Sponsorship Request Form and include the required documentation. The University will conduct a governance and risk review of these documents to decide if the responsibility of sponsorship can be accepted.
Information Required:
- HREC application (including protocol, participant information letters and consent form)
- HREC approval
- Good Clinical Practice Certification
- Risk Review – Work Health and Safety Risk Assessment, Enterprise Risk and RBHSC (if required)
- ANZCTR Registration or equivalent (ClinicalTrial.gov)
- Site Approval (including WA Department of Health Governance Approval if required)
- Clinical Trial Research Agreement
Please note that ECU may not take Sponsor responsibilities for high-risk trials, or multi-site trials where some sites are outside of Perth.