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:

• The reason for doing the study
• Who can join the study
• How many people are needed for the study
• Any drugs they will take, the dose, and how often
• What medical tests they will have and how often
• What information will be gathered about them

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