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.

Who can help?

• The Office for Health and Medical Research have developed a suite of Resources and templates in the Clinical Trial Toolkit to support the conduct of high-quality trials and to assist with the development of your clinical trial protocol.
• Transcelerate provide eTemplates for a protocol and statistical analysis plan
• The US National Institute for Health template aims to support people developing phase II and III trials, and behavioural and social science
• The SPIRIT Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol. Their team has also developed the SEPTRE clinical trial protocol online tool (available on subscription).
• Various other clinical trial templates are available from other Australian sites:
  • Queensland Metro South Addictions and Mental health Service
  • South Australian Health
  • Melbourne Health
  • Western Australia Health

• 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.