How to guide: Following protocols

A protocol is the description of everything which will take place within a research project.

• The protocol is the instruction manual for a research project.
• It should contain all of the things that you need to do.
• It is the reference guide for all activities which have been approved to take place.
• All study staff should be following the latest approved version of the protocol.
• You should not undertake any activity which is not in the protocol.
• It should be kept up to date; when there are any changes, a new version of the protocol should be issued and an amendment submitted to approve the changes. Changes should not be implemented until a new version of the protocol has been approved by the HRA. Staff delivering the study must not make changes – these must be done by the study team centrally.

Full guide

Format:

• The protocol is not always in a standard format – although the Health Research Authority (HRA) does recommend a template for CTIMPs and qualitative research: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/
• The protocol may be in printed and/or electronic format.

Keeping records:

• The protocol should be kept in the site file.
• Superseded versions should be kept in the file but crossed through (or marked as superseded if kept electronically).
• Staff involved in the study must have access to the site file to enable them to refer to the protocol.

Glossary of Acronyms and Terms:

• HRA – Health Research Authority
• CTIMP – Clinical Trial of an Investigational Medicinal Product