Protocol

It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure everyone adheres to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes.

No two research protocols will be the same, but there are common elements and items that need to be addressed. Use the templates below to see examples of the kinds of headings your protocol needs to contain.

The protocol should describe as much detail about the research project as possible, to enable the review bodies to fully understand your study. It should be kept up to date as the research evolves, and include a version number and approval history.

Publishing your protocol

In the interests of transparency we would encourage you to make your protocol publicly available. This will:

• create an early scientific record of your methodology;
  
• help with review and publication of your study results (some journals require protocol publication); and 
  
• potentially reduce duplication of research effort.  

Many publishers now offer a protocol publication service.

Protocol templates

To help you we have provided templates that can support you with developing your research protocol. You may of course use your own template but we recommend that you check it against our examples to ensure that they capture the relevant elements.

• protocol guidance and template for use in a clinical trial of an investigational medicinal product (CTIMP) - for use before 28 April 2026
• protocol guidance and template for use in qualitative research