A clinical trial protocol is a document that describes the background, rationale, objectives, design, data, methodology and planned analyses. It must be designed to safeguard the participants, as well as efficiently and effectively answer your research question/s.

We strongly recommend using a clinical trial protocol template to facilitate your protocol and design; the best template depends on many factors around the design of your study.


Demonstrating Research Impact


Trial Safety

Further reading


  • The Australian Clinical Trials Handbook provides guidance on the legislative, regulatory and Good Clinical Practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods (i.e. medicines or devices not approved by the TGA). It will help you understand your roles and responsibilities under the legislation.