What is required before enrolling any subject in a trial?

• A. No subject should be admitted to a trial before the IRB/IEC issues its written approval/favorable opinion of the trial
• B. Subjects may be enrolled after sponsor approval only
• C. Enrollment may begin after regulatory notification to authorities
• D. Enrollment may begin with verbal approval from the investigator

Answer: (A)

In GCP, you may not enroll anyone until the study has been reviewed and approved by an ethics body. The IRB/IEC must provide written approval or a favorable opinion of the protocol and the informed consent documents before any subject is admitted. This ensures that the rights, safety, and welfare of participants are protected from the outset.

Sponsor approval alone does not authorize enrollment, and regulatory notification or a verbal investigator approval does not meet the requirement for written ethics approval. Only the IRB/IEC’s written approval ensures proper ethical oversight has been established before enrolling subjects.