Who is primarily responsible for regulatory compliance in a clinical trial?

The clinical trial sponsor holds the primary responsibility for regulatory compliance in a clinical trial. This entity, which could be a pharmaceutical company, academic institution, or other organization that initiates and conducts the trial, is accountable for ensuring that the study adheres to all applicable regulations and guidelines, including Good Clinical Practice (GCP) standards.

The sponsor is responsible for submitting necessary documents to regulatory authorities, ensuring that the study is ethically sound, and that the rights and well-being of participants are protected. They also oversee the overall execution of the trial, which includes monitoring compliance with the protocol.

While the principal investigator plays a crucial role in overseeing the day-to-day conduct of the clinical trial and ensuring adherence to the protocol at their site, and study participants contribute to the trial by providing data and feedback, it is ultimately the sponsor that exercises overall control and obligation to regulatory agencies to meet compliance requirements. The data analyst's role is more focused on data management and analysis, which does not involve the broader regulatory compliance responsibilities typically held by the sponsor.