ACRP CRC Exam Question Bank with Complete Solutions

ACRP CRC Exam Question Bank with Complete Solutions An adverse event is defined as one which: a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to the drug d) Is life threatening ANSWER C) Is not necessarily causally related to drug An adverse event is one which: a) Is an unfavorable and unintended sign, symptom, or disease b) Is one that is temporally associated with drug regardless of whether it is related or not c) A Only d) A and B ANSWER d) A and B A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as: a) an adverse event b) an adverse drug reaction c) an unexpected adverse drug reaction d) a serious adverse event ANSWER A) An adverse event A response to a medical product means (Select all that Apply): a) A causal relationship between drug and adverse event is established b) A causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out