Which two roles are typically responsible for safety data collection and reporting in a trial?

• A. Investigator/Institution and Sponsor
• B. Monitor and Data Manager
• C. IRB
• D. Data Safety Monitoring Board

Answer: (A)

The main idea is that safety data collection and reporting are driven by the site investigator and the sponsor. The investigator at each trial site is responsible for actively identifying, documenting, and recording all adverse events and other safety signals from participants, keeping accurate source documents, and reporting serious adverse events to the sponsor within the protocol-specified timelines. The sponsor then pulls safety information from all sites, conducts ongoing safety evaluation, maintains the safety database, and reports safety findings to regulators and ethics committees as required by regulations and the study protocol.

Roles like the IRB/IEC provide oversight to protect participants but don’t usually handle the ongoing collection and reporting of safety data across the trial. The Data Safety Monitoring Board exists in many trials to independently review accumulated safety data and advise on risk–benefit, but it doesn’t perform the primary data collection and is not the standard channel for routine safety reporting. Monitors and data managers support data capture and quality but the responsibility for safety data collection and first-line reporting rests with the investigator and sponsor.