All clinical trials in Australia should be conducted within the framework underpinned by the principles of Good Clinical Practice (GCP) and are regulated primarily by the NHMRC’s National Statement on Ethical Conduct of Human Research 2023 (NS) and/or the Commonwealth's Therapeutic Goods Administration (TGA).
The National Statement (NS) requires that all clinical trials (whether they fall under the CTN or CTA schemes or not) be approved by a properly constituted Human Research Ethics Committee (HREC).
Institutions have significant responsibilities for clinical trials conducted by their researchers and at their sites. These responsibilities include:
The TGA require notification of all clinical trials involving unapproved therapeutic goods (drugs or medical devices) or the intention to start a new trial under the Clinical Trial Notification (CTN) scheme or the Clinical Trial Exemption (CTX) Scheme. Further information regarding these schemes is detailed below under “Therapeutic Goods Authority - CTN/CTA Scheme”.
ECU has developed this framework to assist researchers with institutional governance requirements for conducting a clinical trial as well as ensuring compliance with all external, statutory, and legislative requirements.