Source:http://linkedlifedata.com/resource/umls/id/C1507394
NCI: A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states 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 drugs or other interventions will be given, what tests will be done and how often, and what information will be collected.,NCI: A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents.,NCI: A discrete, structured plan (that persists over time) of a formal investigation to assess the utility, impact