SOCRA CCRP Practice Exam

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Study for the SOCRA CCRP Exam. Equip yourself with flashcards and multiple choice questions, each with hints and explanations. Boost your confidence for exam day!

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How is an adverse event defined in clinical studies?

Any negative feedback from participants
A sign or symptom that develops or worsens during the study
Withdrawal of a participant
A protocol deviation

The correct answer is: A sign or symptom that develops or worsens during the study

An adverse event in clinical studies refers to any sign, symptom, or medical occurrence that develops or worsens during the course of a study. This can range from mild discomfort to severe illness. Option A is incorrect because an adverse event is not limited to negative feedback from participants, but also includes objective medical outcomes. Option C is incorrect because withdrawal of a participant may not necessarily be due to an adverse event. Option D is incorrect because while a protocol deviation can be considered an adverse event, it is a more specific term that refers to any deviation from the study protocol rather than a medical outcome.