CITI Training Practice Exam

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Who has ultimate responsibility for an investigational product?

Pharmacy
Sponsor
Investigator
Regulatory Authority

The correct answer is: Investigator

The ultimate responsibility for an investigational product lies with the investigator. This is because the investigator is the one conducting the study and is responsible for ensuring that the study is conducted ethically and in accordance with all regulations and guidelines. While the pharmacy may handle the dispensing of the investigational product and the sponsor may provide funding and oversight, ultimately it is the investigator who is accountable for the study. The regulatory authority, while also important in ensuring the safety and efficacy of investigational products, has a more oversight role and does not have direct responsibility for the product.