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The sponsor is mainly responsible for reporting adverse drug reactions of an active comparator drug. In clinical trials, the sponsor, often a pharmaceutical company or a clinical research organization, has the obligation to ensure that all safety reporting, including adverse events related to both investigational and comparator drugs, is conducted thoroughly and in compliance with regulatory requirements. This responsibility encompasses collecting, reviewing, and submitting safety data to regulatory agencies, as well as providing information to investigators and patients.

While investigators play a critical role in identifying and documenting adverse drug reactions, their responsibility primarily pertains to the investigational drug being tested. They report these incidents to the sponsor, who then evaluates and submits the necessary reports to regulatory agencies. The regulatory agency itself monitors the safety data but does not have the direct responsibility for reporting adverse events. Lastly, while patients may experience and report adverse reactions, the formal responsibility for reporting lies with the sponsor to ensure compliance with safety regulations.