Which party is responsible for the ongoing safety evaluation of the investigational product?

• A. Investigator
• B. IRB/IEC
• C. Sponsor
• D. Regulatory authority

Answer: (C)

In ongoing safety evaluation of the investigational product, the sponsor holds responsibility. The sponsor is tasked with establishing a safety monitoring plan, collecting and evaluating all safety data from the trial, and ensuring timely reporting of adverse events and any suspected unexpected serious adverse reactions to regulatory authorities and the ethics committee as required. This centralized pharmacovigilance function ensures consistent assessment of risks across all sites and over the product’s lifecycle, which is essential for protecting participants and informing the risk–benefit balance.

The investigator plays a crucial role in patient safety at the site by monitoring participants and promptly reporting adverse events to the sponsor, but the day-to-day safety evaluation and overall safety strategy come from the sponsor. The IRB/IEC focuses on participant protection and ethical oversight and may require safety-related actions, but it does not conduct the ongoing safety evaluation of the investigational product. Regulatory authorities provide oversight and require safety reporting, but the formal ongoing safety evaluation is managed by the sponsor.