Updated ACRP CCRC 500 Exam Questions with 100% SOLUTION

Is not necessarily causally related to drug An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to drug d) Is life threatening d) a and b 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 a) An adverse event 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 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 A response to a medical product means (check all options 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 d) An event that requires active medical intervention b) A noxious and unintended response to a drug An adverse drug reaction is one which a) Results in death or hospitalization b) A noxious and unintended response to a drug c) Occurs frequently and with greater severity than usual d) Likely occurs at normal doses of the drug d) a and b For a drug that is in a Phase IV trial and adverse drug reaction is one which a) Is noxious and unintended b) Occurs at normal doses used for prophylaxis c) a only d) a and b e) All of the above A serious adverse event is on which results in a) Death or life threatening event b) A hospitalization or prolongation of hospitalization c) Persistent or significant disability d) Congenital anomaly or birth defect e) All of the above b) An event where risk of death was evident at the time of the event The term, life threatening, in a serious adverse event refers to a) An event which required hospitalization b) An event where risk of death was evident at the time of the event c) An event that required treatment in an emergency room d) An event which might have caused a death if left untreated d) a and b An event may be classified as serious if it a) Not immediately life threatening, but may jeopardize the patient b) Not immediately life threatening but may require and intervention to prevent hospitalization c) a only d) a and b d) May be considered serious and should be considered for expedited reporting A patient in a clinical I trial for joint pain experiences a bronchospasm while at home. The event would be a) Not reportable because it occurred in a home setting b) An adverse event which does not require reporting c) An unexpected adverse event which does not require expedited reporting d) May be considered serious and should be considered for expedited reporting d) All of the above Events which may be classified as serious even though they do not result in hospitalization include a) Allergic bronchospasm b) Blood dyscrasias c) Convulsions d) All of the above