Who is ultimately responsible for the conduct of the study at a site?

The Investigator is ultimately responsible for the conduct of the study at a site because they are the individual who oversees the entire research process involving human subjects. This responsibility includes ensuring that the study is conducted according to the approved protocol, regulatory requirements, and ethical standards. The Investigator is accountable for the welfare of the participants and must ensure informed consent is properly obtained and that participants are treated with respect and dignity throughout the study.

Additionally, the Investigator is responsible for managing the study team, overseeing the data collection process, and maintaining the integrity of the research data. The Investigator's role is critical in ensuring that protocols are followed and that the study achieves its objectives while upholding participant rights and safety. This level of responsibility cannot be delegated away, making the Investigator the key figure in the study's ethical and scientific integrity.