Clinical research trials are conducted at major public hospitals and other institutions across South Australia. These trials typically investigate the safety and/or efficacy of medical interventions, including medicines and therapeutic devices.
CTN and CTX requirements
Those seeking to undertake a clinical trial within the South Australian public health system under the Therapeutic Goods Administration’s Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) Schemes should ensure the appropriate signed notification forms are provided to the Institution. These can be obtained from the Therapeutic Goods Administration website.
Clinical Trial Agreements
To support the conduct of clinical trials within the South Australian public health system, SA Health endorses the use of the following Medicines Australia Clinical Trial Research Agreements (CTRAs):
- Clinical Trial Research Agreement – Medicines Australia Standard Form
- Clinical Trial Research Agreement – Contract Research Organisation acting as the Local Sponsor
- Clinical Trial Research Agreement – Collaborative of Cooperative Research Group (CRG) Studies
- Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines)
These agreements are all available to download here.
Clinical Trial Agreement Amendments
SA Health participates in a multi-jurisdiction review group to consider amendments to the standard Medicines Australia and Medical Technology Association of Australia CTRA template agreements.
The Southern and Eastern Border States (SEBS) review group meets monthly to consider CTRA amendments. Submissions to this group from clinical trial sponsors will be coordinated through the Office for Research Development, SA Health, via email@example.com. Sponsors should use the template provided on this page for all submissions to this group.
A register of all endorsed CTRA amendments will be maintained by the Office for Research Development. Any enquiries may be directed to the Office for Research Development via the email. Clinical trial sponsors should refer to the Section 7 Clauses approval process leaflet on the Queensland Health website. This leaflet provides further details on the process and considerations of the SEBS review group.