What is a clinical trial “protocol?
A clinical trial protocol is a description of the treatment each participant will undergo, including what medications they will receive or procedures they will experience, the frequency and manner of these interventions, the schedule of tests to determine results, and the length of the clinical trial. The protocol also includes information about participation requirements.
A protocol is a detailed plan that follows strict scientific and ethical guidelines that explain what will be done in a clinical trial, how, and why. These guidelines cover many areas, including the study’s design, who can be in the study, the eligibility criteria, and the kind of information people must be given when they are deciding whether or not to participate.
