Generic Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia
PDF 3.32 MB
SA Health has recently implemented a new system to manage ethics and governance applications as well as post approval monitoring requirements for health and medical research within SA Health. The new system, Research GEMS (Governance and Ethics Management System) has enhanced data collection and reporting capability that will support expanded clinical trials metrics collection and support evaluation of national improvement efforts.
To find out more about Research GEMS please visit the Research GEMS website.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve human participants. Compliance with GCP standards ensures the rights, safety and well-being of clinical trial participants are protected and that the quality of data is credible.
SA Health supports the adoption of the Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia that are based on ICH GCP and developed by Queensland Health.
These Standard Operating Procedures (SOPS) incorporate the recommendations from the Clinical Oncology Society of Australia (COSA) Australasian Teletrial Model – A National Guide to Implementation, September 2016.
The Teletrials Supervision Plan and the Teletrials Clinical Consultation User Guide can be used in conjunction with the Teletrials SOPs.
These SOPs complement institutional and sponsor SOPs and should be used to guide clinical practice. Where local requirements need to be added to these SOPs, whichever SOPs offer the highest standards of safety and practice should be applied.
The Commonwealth Department of Health have released the National Teletrials Compendium that has been endorsed by all states and territories, together with the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC), through the Clinical Trials Project Reference Group (CTPRG).
The compendium consists of 2 publications, one covers principles and the other covers standard operating procedures for clinical trials and teletrials. The National Teletrials Compendium will help organisations and people who conduct clinical trials.
Office for Research
Department for Health and Wellbeing