1. Australian Therapeutic Goods Act 1989 - Sect 41BD,2020
2. The PRECIS-2 tool: designing trials that are fit for purpose;Loudon;BMJ,2015
3. Use of real-world evidence to support regulatory decision-making for medical devices,2020
4. Medical device innovation consortium (MDIC) clinical trial innovation and reformation (CTIR) committee. A framework for simplification of clinical trials in regulated medical devices,2016
5. Standards for clinical research: keeping pace with the technology of the future;Antman;Circulation,2016