Clinical study protocol
A clinical study or research protocol refers to the document that describes what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study therapy or other interventions will be given, what tests will be done and how often, and what information will be collected. A protocol guides the study and associated data collection and analysis in a productive and standardized manner and is carefully designed to safeguard the participants’ health and answer specific research questions.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
NIH Clinical Research Trials and You The Basics: What are clinical trial protocols?
UCSF Clinical Research Resource HUB: Clinical trial protocol development