Clinical Research Glossary

protocol protocol


A complete description of the research plan and procedures.

Example of protocol in a sentence

The protocol is like a recipe to make sure the research study is done in the same way by all of the study team members.

More Info

A protocol is shared among study team members and approved by an institutional review board (IRB) to ensure that the study procedures are conducted consistently. Participants do not usually get to review the complete protocol but its content will be discussed during the informed consent conversation and at study visits.

Other info to think about when joining a study

You may learn about the term “protocol” from the study team or in the consent form.

The protocol could be discussed when the study team talks about the instructions they have to to follow to run the study.

Although the protocol is not always shared directly with participants, participants may find the study protocol on trial registration sites like

Feel free to ask the study team any questions you have about the study protocol.

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