SOCRA CCRP Practice Exam

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Which of the following is NOT one of the 8 basic elements of informed consent per FDA guidelines?

Description of compensation for top executives
Expected duration of the study
Confidentiality measures
Statement that participation is voluntary

The correct answer is: Description of compensation for top executives

While the other options are included in the 8 basic elements of informed consent per FDA guidelines, Description of compensation for top executives is not. This is because compensation for top executives is not relevant to the participant's decision-making in giving informed consent. The 8 basic elements are designed to ensure that participants have all the necessary information to make an informed decision about their participation in a study.