COVID-19 guidance for clinical trials:
Please visit the Australian Government’s Department of Health website to view the COVID-19 guidance for institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors.
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.
The Australian Government is leading a body of work to improve the Australian clinical trials environment with a view to improving health outcomes and increasing international investment in Australia
The Office for Research based in the SA Department for Health and Wellbeing has received funding through the Encouraging More Clinical Trials in Australia Project to assist with the redesign of clinical trial systems in accordance with the revitalised COAG health council clinical trials agenda.
The Department will be working collaboratively to support a range of key initiatives linked with the national clinical trials agenda, including:
- working closely with key stakeholders including the SA Local Health Networks, Health Translation SA, Adelaide BioMed City, the South Australian Health and Medical Research Institute, South Australian universities and Health Industries SA to develop a strategic, whole-of-system, streamlined approach to clinical trials in South Australia.
- Implementing a new research ethics and governance management system for SA Health, with enhanced data collection and reporting capability that will support expanded clinical trials metrics collection and support evaluation of national improvement efforts. The new system is called Research GEMS (Governance and Ethics Management System).
- supporting the development of a central web portal of key clinical trials information and activities in South Australia
- providing specialised support and advice to support clinical trials teams across SA Health working with key stakeholders to implement a central point of contact for sponsors, researchers, coordinators and participants.
As this work progresses, it is anticipated that other priority areas will be identified that will require further attention.
- Australian Government Department of Health Clinical Trials
- Adelaide BioMed City Clinical Trials
- Australian Clinical Trials portal
- Australian and New Zealand Clinical Trials Registry (ANZCTR)
- Research GEMS
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)
- Clinical Trial Research Agreement – Phase 4 (Medicines) – Contract Research Organisation acting as the Local Sponsor
These agreements are all available to download on the Medicines Australia website.
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 clinical trials research webpage.
Please contact the SA Department for Health and Wellbeing Office for Research