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 the Southern and Eastern Border States (SEBS) review panel to consider amendments to the standard Medicines Australia Clinical Trials Research Agreement (CTRA) template agreements.
The SEBS panel meets regularly to consider amendments to the template agreements via Schedule 4 and Schedule 7 additions. Submissions to this group from Clinical Trial Sponsors are coordinated by the NSW Office for Health and Medical Research, SEBS@moh.health.nsw.gov.au.
For further information on the SEBS review process including a submission template, meeting and submission dates, please visit the Medicines Australia website.