Question

Which 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.

Answer 1

Explanation:

A.Seriousness(threatening life or function)

Answer 2

Expectedness (option B) is the correct response because it does not need the sponsor to report to FDA in a timely manner.

This can be explained in the following way:

• According to FDA guidelines, expedited reporting refers to the sponsor's timely reporting to the FDA of any unanticipated serious or non-serious adverse event related with the investigatory product.
• The expectedness of any event can be defined as those events that are known adverse effects of specific medications prior to therapy.
• Expected occurrences do not usually need to be reported to the regulatory body because they are anticipated from the start of the clinical trial.
• In the Investigator Brochure, the likelihood of adverse events is indicated. Only unanticipated adverse events should be reported to the FDA.