ACRP-MDP Practice Questions - ACRP Medical Device Professional Exam

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A clinical research coordinator discovers that a study subject received a dose of the investigational product that was 50% higher than specified in the protocol. What is the FIRST action the coordinator should take?

Discontinue the subject from the study immediately Wait for the next scheduled visit to address the issue Ensure the subject's immediate safety and document the event as a protocol deviation Contact the sponsor to request additional investigational product

Correct Answer:

Ensure the subject's immediate safety and document the event as a protocol deviation

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