Early Phase Trials Best Practice Checklist

This checklist provides a summary of recommendations, considerations and resources for clinical research sites in the conduct of clinical trials, particularly those sites conducting early phase studies. For existing clinical trial sites it will validate your current practices, for new sites it will guide you in your set up.

Getting Started with the Checklist

Click on the image below for an Excel checklist of best practice requirements for the conduct of clinical trials. Work through each tab of the checklist in your preferred order.  (Instructions and FAQ's can be found in the links to the right).

The summary page of the checklist gives you the option to only show your 'NO' responses, so you can see what areas your site needs to focus on to meet best practice standards.


We are interested in your feedback on both the content and functionality of the checklist. Your feedback is incredibly valuable in helping us to refine the current Excel version and enable the future development of an online based checklist. Provide your feedback

CT:IQ project team

The checklist was developed by a project team from CT:IQ Steering Committee member organisations, bringing a broad range of experience and expertise from within the Australian clinical trials sector to the project. See who was on the project team.


The project team would like to thank those people from across the sector who kindly provided their expert knowledge and time to test and review the checklist before it was launched.

Project journal article

An open access article on this project has been published in the Contemporary Clinical Trials Communications journal (December 2020): Clinical trials best practice checklist: Guidance for Australian clinical research sites from CT:IQ

Project literature review

A literature review was conducted at the commencement of the project to inform the development of the checklist: Review of site practices and guidelines for best practice approaches in the conduct of early phase clinical trials. May 2019


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