What action is typically taken during the termination site visit?

What action is typically taken during the termination site visit?

• A. Initiating new studies
• B. Returning unused investigational agents
• C. Staff performance review
• D. Review of regulatory files

Answer: (B)

During the termination site visit, the primary action taken is the return of unused investigational agents. This step is crucial to ensure that all materials related to the study are accounted for and appropriately dealt with after the conclusion of the trial. By returning unused investigational drugs or medical devices to the sponsor or their designated representative, the site helps maintain compliance with regulatory requirements and good clinical practice standards. This action also helps prevent potential misuse or misappropriation of these agents that were dedicated to research purposes. Additionally, the return of investigational agents is part of the process of closing out a study, ensuring that the site manager and sponsors have a clear understanding of what has been used, what remains, and what needs to be safely disposed of or retained for auditing and accountability purposes.

During the termination site visit, the primary action taken is the return of unused investigational agents. This step is crucial to ensure that all materials related to the study are accounted for and appropriately dealt with after the conclusion of the trial. By returning unused investigational drugs or medical devices to the sponsor or their designated representative, the site helps maintain compliance with regulatory requirements and good clinical practice standards. This action also helps prevent potential misuse or misappropriation of these agents that were dedicated to research purposes.

Additionally, the return of investigational agents is part of the process of closing out a study, ensuring that the site manager and sponsors have a clear understanding of what has been used, what remains, and what needs to be safely disposed of or retained for auditing and accountability purposes.