Participant Safety & Adverse Events 1. 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 visits as scheduled without exception. D. Report it as a serious adverse event (SAE). 2. 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 clinical investigation subject involvement. D. Causal relationship with the pharmaceutical product. E. A, B, and C only. F. All of the above. 3. A serious adverse event (SAE) does NOT need to be reported to NIDA or designee within 24 hours in which of the following situations? A. The investigator considers the SAE unrelated to the study intervention. B. The SAE is non-fatal and non-life-threatening. C. The SAE occurs in a behavioral study. D. The SAE occurs in a non-Investigational New Drug study. E. The SAE occurs in the post-treatment observation period. F. None of the above. 4. A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours D. Follow the local IRB reporting guidelines. 5. Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used? A. Investigator Brochure B. Protocol C. Informed Consent Form D. Annual Safety Report E. All of the above may be used.
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