What is a study sponsor's primary responsibility in clinical trials?

A study sponsor's primary responsibility in clinical trials encompasses ensuring regulatory compliance and ethical conduct. This means the sponsor must make sure that the research adheres to established laws, regulations, and ethical guidelines designed to protect human subjects. This includes the implementation of protocols that safeguard participants' rights, safety, and well-being throughout the study. It involves a commitment to operate within the framework set by regulatory bodies such as the FDA or the IRB, ensuring that the study is conducted according to scientific principles and ethical standards.

While managing day-to-day operations, participant recruitment, overseeing data collection, and publishing results are also important aspects of a study's workflow, they are typically delegated to various roles within the research team or organization. The responsibility of ensuring overall compliance and ethical integrity falls primarily on the sponsor, who must maintain oversight to mitigate any potential risks to participants and uphold the credibility of the research.