SOCRA CCRP Practice Exam

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What does a sponsor-investigator do according to 21 CFR 312.3?

  1. Only sponsors the investigation

  2. Only conducts the investigation

  3. Initiates and conducts the investigation

  4. Administers the finances of the investigation

The correct answer is: Initiates and conducts the investigation

A sponsor-investigator does not only sponsor the investigation (option A) as they are also directly involved in the conduct of the study. They also do not only conduct the investigation (option B) as they are responsible for the overall organization, management, and execution of the study. Option D is incorrect as they do not just manage the finances, but also have responsibilities for the conduct of the investigation. Therefore, the best answer is option C, as it encompasses all of the responsibilities and roles of a sponsor-investigator according to 21 CFR 312.3.

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