Medicines Australia Clinical Trial Research Agreements (CTRA)
A clinical trial agreement might be required for the research governance application to legally formalise the obligations and relationship between the clinical trial sponsor, researcher/s and institution where a clinical trial is conducted.
SA Health endorses the use of the following Medicines Australia Clinical Trial Research Agreements (CTRA) to support the conduct of clinical trials within the South Australian public health system:
- Medicines Australia Standard Form
- CTRA: Contract Research Organisation acting as the Local Sponsor
- Collaborative of Cooperative Research Group (CRG) Studies
- Phase 4 Clinical Trial (Medicines)
- Phase 4 (Medicines) – Contract Research Organisation acting as the Local Sponsor
- Teletrials Subcontract – Complements the Clinical Trials Research Agreement – Medicines Australia Standard Form.
These agreements are all available to download on the Medicines Australia website.
Southern and Eastern Border States (SEBS) review panel
SA Health participates in the Southern and Eastern Border States (SEBS) review panel to consider amendments to the standard CTRA.
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.
For further information on the SEBS review process including a submission template, meeting and submission dates, please visit the Medicines Australia website.
For more information about conducting clinical trials in South Australia and the requirements for clinical trials agreements, please contact the Office for Research in the SA Department for Health and Wellbeing.