Which of the following best describes what should be included in risk reporting by the sponsor?

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Risk reporting should clearly communicate how identified risks are being controlled and what happened as a result. The sponsor needs to describe the risk control measures in place, the outcomes of those measures, and any remedial actions taken, with all of this documented in the trial records. This creates a traceable, ongoing record of how risks to participant safety and data integrity are managed throughout the study.

Daily site visit schedules are purely operational planning and don’t reflect risk control status. Personnel training records show who was trained, not how risk was mitigated. A general summary of quality issues and instances of out-of-range results might be part of quality oversight, but it doesn’t focus on the effectiveness of risk controls and remedial actions, which is the essence of risk reporting.