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Question: 1 / 400

Who is ultimately responsible for a clinical trial being conducted according to regulations?

The principal investigator only

The FDA

The ethics committee

Sponsor or sponsor-investigator via Clinical Trial Monitor or CRA

The sponsor or sponsor-investigator is ultimately responsible for ensuring that the clinical trial is conducted according to regulations. While the principal investigator, FDA, and ethics committee play important roles in the trial, the sponsor or sponsor-investigator has the overall responsibility for overseeing and managing the trial. This includes ensuring that all aspects of the trial adhere to regulations and that the safety and well-being of participants is prioritized. Therefore, the other options (A, B, and C) are incorrect as they do not hold the same level of responsibility as the sponsor or sponsor-investigator.

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