Which bodies have the power to regulate clinical trials?

• A. Source Documents
• B. Regulatory Authorities
• C. Quality Assurance
• D. Protocol Amendment

Answer: (B)

Regulatory authorities are the formal bodies with the legal power to regulate clinical trials. They set and enforce the rules that govern trial design, conduct, participant protection, and data integrity, and they grant, suspend, or terminate permission to run a study. They require safety reporting, monitor compliance through inspections, and can mandate corrective actions or protocol changes as needed. Source documents and QA activities are parts of how trials are run and checked, and a protocol amendment is a change to the trial plan—the regulator may need to review or approve it, but the authority to regulate comes from Regulatory Authorities, not those other elements. Examples include the FDA in the United States and equivalent agencies worldwide.