Participant Safety & Adverse Events 1Which adverse event...

Participant Safety & Adverse Events

1Which adverse event feature is NOT used to determine whether expedited reporting to the FDA by the Sponsor is required?

A. Seriousness (threatening life or function)

B. Expectedness

C. Causal relationship with study product

D. Severity

E. All of the above.

2Which 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.

3The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants.

A. File it in regulatory binder.

B. Report to local IRB.

C. Inform all participants.

D. All of the above.

4The person(s) responsible for assuring the safety and rights of study participants include:

A. Principal Investigator.

B. Sub-Investigator.

C. Data and Safety Monitoring Board.

D. Research Assistant.

E. Study Physician.

F. Phlebotomist.

G. All of the above.

5A 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.