During the trial, which entity monitors safety data continuously?

• A. The investigator monitors safety data continuously
• B. The sponsor monitors safety data continuously during the trial
• C. Regulatory authorities monitor safety data
• D. No monitoring is required

Answer: (B)

Continuous safety monitoring in a clinical trial is handled by the sponsor. The sponsor aggregates safety information from all sites, reviews it on an ongoing basis, and is responsible for the timely reporting of adverse events and any suspected unexpected serious adverse reactions to regulatory authorities. This centralized monitoring allows detection of safety signals across the whole trial and decisions about actions like protocol changes or stopping rules. Investigators monitor safety for their own participants at their site and report SAEs to the sponsor, but the ongoing cross-site safety surveillance is the sponsor’s responsibility. Regulators may review safety data and request reports, but they do not continuously monitor the trial dataset in real time. No monitoring is not correct because safety oversight is required.