This handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using 'unapproved' therapeutic goods. It assists trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) to understand their roles and responsibilities under the therapeutic goods legislation.
Information about clinical trials for consumers can be found on the Australian Clinical Trials website.
This handbook does not describe all of the requirements for conducting clinical trials in Australia. It refers to other relevant publications throughout that should be read in conjunction with this guidance.
This handbook describes the two schemes under which clinical trials involving 'unapproved' therapeutic goods may be conducted in Australia:
- Clinical Trial Notification (CTN) scheme
- Clinical Trial Approval (CTA) scheme
Clinical trials that do not involve the use of 'unapproved' therapeutic goods are not subject to the requirements of the CTN and CTA schemes.
- About this handbook
- Clinical trials involving therapeutic goods
- Is the product a therapeutic good?
- Determine the type of therapeutic good
- Determine if the product is 'unapproved'
- Certain 'unapproved' therapeutic goods used in clinical trials
- The Australian regulatory environment
- Therapeutic goods legislation
- Declaration of Helsinki
- The National Statement on Ethical Conduct in Human Research
- Good Clinical Practice (GCP)
- State and territory requirements
- The CTN and CTA schemes
- Choosing between the CTN and CTA schemes
- The CTN scheme
- The CTA scheme
- Extensions of clinical trials
- Post-trial provisions
- Responsibilities under the CTN and CTA schemes
- Role of trial sponsors
- Role of Human Research Ethics Committees (HRECs)
- Role of approving authorities
- Role of principal investigators
- Role of TGA
- Safety reporting to TGA for CTN and CTA trials
- Safety reporting timeframes for CTN and CTA trials
- Single case events from Australian sites: SUSARs and USADEs
- Significant safety issues including urgent safety measures
- Other report types
- Clinical trial phases and stages
- Summary of clinical trial phases for medicines and biologicals
- Summary of clinical trial stages for medical devices
- Early phase trials
- Medical device stages
- Advertising ‘unapproved’ therapeutic goods
- Manufacturing medicines and biologicals for use in a clinical trial
- Manufacturing medical devices for use in a clinical trial
- Manufacturing exemptions
- Import restrictions for therapeutic goods
- Importing therapeutic goods for use in clinical trials in Australia
- Six monthly reports
- Retrieval, destruction and export of unused clinical trial material