-Indiana Medical Res
Good Clinical Practice
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Quiz: Participant Safety & Adverse Events
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?
OA No action is required.
OB. Report it as an adverse event (AE).
OC. Remind the participant of the importance of attending study visit as scheduled without exception
OD Report it as a serious adverse event (SAE).
2 All serious adverse events (SAES) must be reported to the research site's Institutional Review Board