Participant Safety & Adverse Events 1A participant missed...

Participant Safety & Adverse Events

1A 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.

2The severity of an adverse event (AE) is the same as its seriousness.

A. TRUE

B. FALSE

3Who can report an adverse event (AE)?

A. Participant

B. Participant's spouse

C. Caregiver

D. Participant's family member

E. Research Nurse

F. All of the above can report an AE

4A 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.

5A serious adverse event (SAE) does NOT need to be reported to NIDA or designee within 24 hours in which of the following situation:

A. The investigator considers the SAE unrelated to 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.