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