What happens at the end of a study regarding investigational agents?

At the conclusion of a study involving investigational agents, the standard procedure is that these agents are typically shipped back to the sponsor unless there is an explicit agreement or instruction that states otherwise. This process is in place to ensure that the sponsor can manage the investigational agents properly, including their storage, disposal, or potential use in future clinical trials.

The shipment back to the sponsor allows for a controlled environment in which the investigational agents can be accounted for, ensuring compliance with regulatory requirements. This controlled approach also supports the integrity of the study data by preventing unauthorized access or misuse of the investigational products.

In contrast, retaining the agents for future studies or transferring them to a third-party supplier do not align with standard practices, as these actions could result in regulatory violations and compromise the study’s integrity. Destruction on-site may also be necessary, but only under certain conditions, and usually, the responsibility lies with the sponsor unless otherwise directed.