Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

Question: 1 / 400

In what situation should the investigational product be destroyed by the site?

When disposal is determined by the subjects

When not explicitly authorized by the sponsor

When the study concludes and proper procedures are followed

The correct understanding reflects that the investigational product should be destroyed by the site when the study concludes and proper procedures are followed. This ensures that the disposal of the investigational drug is compliant with regulatory requirements and maintains the integrity and safety protocols of the study. At the end of a study, often specific guidelines are established, and sites are expected to adhere to designated procedures, which may include returning the product to the sponsor or disposing of it according to established regulations.

When the product is expired, it may require disposal, but that is not the primary determination—it needs to be considered within the context of the study's conclusion and procedures. Similarly, allowing subjects to determine disposal methods could lead to various issues including safety and compliance violations, which don't align with proper clinical study protocol. Lastly, destruction due to lack of authorization by the sponsor also doesn’t address the structured conclusion of a study, where proper guidelines already exist for product disposal. Each of these situations lacks the formal conclusion of the study protocol, highlighting why the destruction of the investigational product should be carefully mapped out following the study's end.

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When the product is expired

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