SOCRA CCRP Practice Exam

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How are subjects informed of new findings during a study according to FDA guidelines?

Through the media
In the study's initial consent form
Statement that new findings will be provided to subjects
Subjects are not informed of new findings

The correct answer is: Statement that new findings will be provided to subjects

According to FDA guidelines, subjects participating in a study are ensured to be fully informed of any new findings that may arise during the course of the study. This is typically done through a statement in the initial consent form, where participants are made aware that they will be notified of any significant developments. This ensures that subjects are aware of any potential risks or changes in the study that may affect their participation. Options A and D are incorrect because they do not follow FDA guidelines of keeping subjects informed. Option B is also incorrect as it does not address the process of informing subjects of new findings, but rather just the initial consent process. Therefore, option C is the correct choice as it aligns with FDA guidelines for keeping subjects informed during a study.