Key information you should be aware of:
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- Superseded versions should be kept in the file but crossed through (or marked as superseded if kept electronically).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
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.
- 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- Superseded versions should be kept in the file but crossed through (or marked as superseded if kept electronically).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
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