[Answer] A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event?

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A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event? Blood studies are positive for a heart attack and the subject is hospitalized . The subject has a history of coronary artery disease . The subject reports to the ED nurse that he is currently enrolled in a phase I study of a new lipid lowering agent . Which individual should determine causality of the serious adverse event ? Blood studies are positive for a heart attack and the subject is hospitalized . The subject has a history of coronary artery disease . The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent . Which individual should determine causality of the serious adverse event ? Blood studies are positive for a heart attack and the subject is hospitalized . The subject has a history of coronary artery disease . The subject reports to the ED nurse that he is currently enrolled in a Phase 1 study of a new lipid lowering agent . Which individual should determine causality of the serious adverse event ? Blood studies are positive for a heart attack and the subject is hospitalized . The subject has a history of coronary artery disease . The subject reports to the ED nurse that he is currently enrolled in a Phase 1 study of a new lipid lowering agent . Which individual should determine causality of the serious adverse event ? A 59-year-old man presents to the emergency department ( ED ) com-plaining of new -onset chest pain that radiates to his left arm. He has a histor...

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