SOCRA CCRP Practice Exam

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What is the role of a sub-investigator according to FDA regulations?

Leader of the investigative team
Regulatory body member
Individual member of the clinical investigator's team
Sponsor's representative in a clinical trial

The correct answer is: Individual member of the clinical investigator's team

Sub-investigators play a crucial role in assisting the clinical investigator with conducting a study. This includes tasks such as recruiting participants, obtaining informed consent, and collecting and managing data. They also help ensure that the study is conducted in compliance with FDA regulations and the protocol. Option A, B, and D are incorrect because they do not accurately describe the role of a sub-investigator according to FDA regulations. The leader of the investigative team is typically the clinical investigator, while the regulatory body member is usually a different position within the FDA. The sponsor's representative may be involved in a clinical trial, but their role is not specific to FDA regulations and the sub-investigator's responsibilities. Therefore, option C is the most accurate answer.