In the context of a clinical study, who is primarily responsible for ensuring the compliance of the trial with applicable regulations?

The Investigator is primarily responsible for ensuring that the clinical trial complies with applicable regulations. This responsibility is foundational, as the Investigator plays a central role in the conduct of the study at the site level. They oversee the day-to-day operations of the study and ensure that it adheres to the protocol, ethical guidelines, and regulations set forth by regulatory authorities and institutional review boards.

The Investigator is responsible for the safety and well-being of the research subjects and must ensure that informed consent is obtained, that adverse events are reported appropriately, and that the data collected is accurate and reported in line with regulatory requirements. Their comprehensive knowledge of the study protocol, regulations, and ethical considerations is essential for maintaining compliance throughout the study.

The other roles, while they have significant responsibilities, do not hold the ultimate accountability for regulatory compliance as the Investigator does. For instance, the Sponsor provides funding and may set guidelines for the study, but the Investigator directly manages compliance on-site. Similarly, the Clinical Research Associate monitors the study and supports compliance but does not have the overall authority that resides with the Investigator. The Data Manager's role is focused on data integrity and management, which is crucial, but again, it does not encompass the comprehensive regulatory responsibility of the Investigator.