A clinical trial (study) protocol for a new treatment consists of all the rules that are followed throughout the study. These guidelines include:
• Numbers of patients
• Types of patients
• Administration of the new treatment
• Administration of other treatments that may be given during the study
• Data (such as symptoms of the disease, X-rays, and laboratory data) to be recorded on the effectiveness of the treatment
• Safety data (such as side effects) to be recorded
• Length of study
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