What is a primary responsibility of sponsors in a clinical investigation?

One of the primary responsibilities of sponsors in a clinical investigation is indeed to select qualified investigators. The sponsor plays a crucial role in ensuring that individuals who will lead the study possess the necessary qualifications, training, and experience to conduct the research effectively and ethically. This selection process is essential because investigators are responsible for the conduct of the study at their sites, including compliance with regulatory requirements, adherence to the study protocol, and the safety and welfare of study participants.

By selecting qualified investigators, sponsors contribute to the integrity and reliability of the clinical trial data, as well as the overall success of the trial. They must assess the investigators’ backgrounds, institutional affiliations, and previous experience in similar studies, ensuring that they have the appropriate resources and support systems in place. This responsibility is vital in establishing a competent team that can uphold the standards of Good Clinical Practice (GCP) throughout the investigation.