Biostatistics guidance

Guidance on how to write a good protocol

The Biostatistics Group has produced guidelines for the writing of protocols for clinical trials (non-CTIMPs) and observational studies.

Clinical Trials (non-CTIMPs)

The aim of the clinical trials guide (non-CTIMPs) is to help researchers with the content and structure of protocols for clinical trials. It indicates the information that should generally be included in a protocol and has been constructed to cover important methodological considerations and requirements specified under Good Clinical Practice.  There are links in this document to obtain more information about some topics, and a list of recommended references at the end.

Observational Studies

The aim of the observational studies guide is to help researchers write a research study protocol for an observational study. The guide will take you through each section of the protocol giving advice and examples of the information required in that section. This is a guide only and for those requiring more information on particular topics, some useful references are given at the end of this document.