(Solved): A participant missed several study visits and the research site staff becomes aware of a participan ...

A participant missed several study visits and the research site staff becomes aware of a participant's death searching through public records. What is the most appropriate next course of action? A. Report this as a serious adverse event (SAE). B. Report this as an adverse event (AE). C. No action is required. D. Contact the Study Physician for instructions on next steps. The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants. A. File it in regulatory binder. B. Report to local IRB. C. Inform all participants. D. All of the above.