A participant reported migraine headache and missed work for a day. Is this an AE?…

A participant reported migraine headache and missed work for a day. Is this an AE?
A. Check baseline medical history
B. Assess the severity level
C. Assess if there is change from baseline.
D. 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).
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.
Examples of adverse events (AE) include which of the following?
A. Damaged wheelchair.
B. Anxiety.
C. Decreased blood sodium.
D. Enlarged thyroid on physical examination.
E. B, C, and D only
F. All the above are adverse events (AEs).
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.