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The overall goal of monitoring, audits, and inspection activities is to: A) Review research related publications. B) Ensure the protection of human research subjects and data integrity. C) Manage conflict of interest. D) Resolve disputes between the sponsor and the investigators {Ans: B}The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and: A) (3) can reasonably be expected to recur. B) (3) is life-threatening but listed in the Investigator's Brochure. C) (3) resolves quickly. D) (3) there is a reasonable possibility that the drug caused the event. {Ans: D}Consider a study conducted a regional hospital where the investigator is one of the on staff physicians. The study focuses on smoking habits among the hospital's nurses and its relationship to lung cancer. Does this research involve subjects potentially vulnerable to coercion or undue influence? Yes or no. {Ans: The answer is yes. Because the nurses are members of a hierarchical structure within the study facility, the nurses are considered to be vulnerable to coercion or undue influence.}The investigator must report adverse events to the: A) FDA B) Sponsor C) IRB only D) Subject {Ans: B}The FDA