Which term best describes the formal opinion issued by an Independent Ethics Committee regarding trial ethics and participant safety?

• A. IEC Opinion
• B. Randomization
• C. QA
• D. Source Documents

Answer: (A)

The formal opinion issued by an Independent Ethics Committee about trial ethics and participant safety is called the IEC Opinion. In GCP, the IEC (or ethics committee) reviews the protocol, informed consent forms, and safeguards for protecting participants. The outcome is a written, formal decision stating whether the study is ethically acceptable to proceed, sometimes with conditions that must be met before approval or before continuing after changes.

This isn’t about how participants are assigned to groups (randomization), nor about internal processes to ensure quality (QA), nor about the records used to verify data (source documents). Those concepts serve different roles in trial conduct, whereas the IEC Opinion specifically documents the ethical assessment and safety considerations required to protect participants.