The protocol is a key document which explains what you are going to do in your research study. It is a useful document for pulling together information and describing your study to members of the research team, to research sites and regulatory bodies. It forms a part of your IRAS application. Your protocol may need to be updated over the course of your study to ensure it is always an accurate record of what is taking place.

Writing a good protocol which clearly describes the study is important and some advice can be found at the following links:

You can also contact the Research Design Service for help.

Applications must include a plain English summary. Advice from the NIHR’s ‘Make it Clear’ campaign can be found here.