What is a clinical trial protocol?
A clinical trial protocol is a comprehensive plan that outlines the study’s objectives, design, methodology, statistical considerations, and organisation. It specifies:
- The purpose of the study
- Eligibility criteria for participants
- Details of tests, procedures, medications, and dosages
- The schedule of activities
- Information to be collected about participants
This protocol ensures the study is conducted consistently and safely across all participants.
More common questions
- How long do the appointments or visits last?
- Will it cost me anything to participate?
- Is my information kept confidential?
- What questions should I ask the research team?
- What happens during a clinical research study?
- What is a clinical trial?
- What do the different phases of a clinical trial mean?
- Why should I participate in a clinical trial?
- What types of clinical trials are available?