These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.