Standard Operating Procedures (SOP) for clinical trials, including teletrials
Standard Operating Procedures (SOP) for clinical trials, including teletrials, are consistent with the minimum standards imposed by the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 (R2), which is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that involve participation of humans.
SA Health supports the adoption of SOP for clinical trials, including teletrials, in Australia that are based on ICH GCP and developed by Queensland Health. These SOP incorporate the recommendations from the Clinical Oncology Society of Australia (COSA) Australasian Teletrial Model – A National Guide to Implementation, September 2016, and are available in Generic Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia (PDF 3.3MB)
These SOP complement institutional and sponsor SOP and should be used to guide clinical practice. Where local requirements need to be added to these SOP, whichever SOP offer the highest standards of safety and practice should be applied.
Therapeutic Goods Administration 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 Approval (CTA) Schemes should ensure the appropriate signed notification forms are provided to the Institution. These can be obtained from the Therapeutic Goods Administration website.
For more information about conducting clinical trials in South Australia, please contact:
Office for Research
Phone: (08) 8226 7235
For more information about teletrials, please visit the teletrials page, or contact:
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)