The guidelines that clinical trials follow clearly state who will be able to join the study and the treatment plan. Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which is like a recipe for conducting a clinical trial.
The protocol explains what the trial will do, how the study will be carried out, and why each part of the study is necessary. It includes information on:
Source: The National Cancer Institute Reviewed 7/17 /07