How to guide: Following protocols
A protocol is the description of everything which will take place within a research project.
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The protocol is the instruction manual for a research project.
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It should contain all of the things that you need to do.
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It is the reference guide for all activities which have been approved to take place.
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You should not undertake any activity not in the protocol.
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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
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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/
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Participants must be fully informed and in a position to consent (having capacity to consent).
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The protocol should be kept in the site file.
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Superseded versions should be kept in the file but crossed through (or marked as superseded if kept electronically).
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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
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HRA - Health Research Authority
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CTIMP - Clinical Trial of an Investigational Medicinal Product