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.
-
You should not undertake any activity 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. 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/
Contents:
-
Participants must be fully informed and in a position to consent (having capacity to consent).
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Superseded versions should be kept in the file but crossed through (or marked as superseded if kept electronically).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