(Solved): Mandatory elements in the definition of an adverse event (AE) include which of the following? A. Un ...

Mandatory elements in the definition of an adverse event (AE) include which of the following? A. Untoward medical occurrence B. Use of pharmaceutical product or a study intervention. c. Patient or cinical investigation subject imolvement. D. Causal relationship with the pharmaceutical product E. A. B, and $$\mathrm{C}$$ only F. All of the above. A participant missed a study visit as he was hospitalized for pneumonia, and then he reported to the study clinic a week later. What is the most appropriate course of action? A. No action is required. B. Report it as an adverse event (AE). C. Remind the participant of the importance of attending study visit as scheduled without exception D. Report it as a serious adverse event (SAE).