Who is ultimately responsible for product accountability at the study site?

The investigator is ultimately responsible for product accountability at the study site because they are the individual with ultimate oversight of the clinical trial. The investigator ensures that all aspects of the study are conducted in accordance with the protocol, regulatory requirements, and Good Clinical Practice guidelines. This includes overseeing the handling, storage, and dispensing of any investigational products to ensure that they are managed appropriately and safely throughout the trial.

In a clinical research context, the investigator is typically a physician or a qualified healthcare professional who has the authority and responsibility for the research conducted at their site. They ensure that the study is compliant with regulatory standards and that all investigational products are accounted for, which involves maintaining accurate records of product receipts, usage, and any returned or unused products.

Others involved in the study, such as the clinical research coordinator and pharmacist, play crucial supporting roles in managing different aspects of the trial, but their responsibilities fall under the oversight of the investigator. The subjects participating in the trial are not responsible for product accountability; they follow the protocol as directed by the investigator and study team.