How is subject safety addressed in a GCP trial?

• A. By ignoring mild adverse events
• B. By collecting and reporting adverse events and other safety data
• C. By stopping the trial after any adverse event
• D. By only reporting lab results

Answer: (B)

In GCP trials, subject safety is addressed by systematically collecting information on adverse events and other safety data, then assessing and reporting it promptly. Investigators document all adverse events, determine their seriousness, severity, and possible relationship to the study intervention, and relay these findings to the sponsor, ethics committee, and regulatory authorities as required. Safety data also includes lab results, vital signs, and other protocol-defined safety endpoints, all analyzed to monitor risk and guide actions if needed. This ongoing monitoring supports the ethical obligation to protect participants and ensures the study can be adjusted or halted if the risks outweigh the benefits. Ignoring mild adverse events or stopping the trial after any single event are not aligned with proper safety oversight; safety is maintained through continuous collection, assessment, and timely reporting of all relevant safety information.