Protocol
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Also referred to as a clinical protocol or a study protocol, a complete description of the research plan and procedures. It is like a recipe to make sure the research study is done in the same way by all research personnel. A protocol cannot be deviated from without prior permission from the sponsor and the Institutional Review Board (IRB) of oversight. Clinical Research Glossary – Plain Language Definitions (mrctcenter.org)
Protocol (ICH GCP): A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. ICH GCP, 1.44
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