Question

A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs.
a) The subject should have contacted the study site for authorization before going to the emergency room.
b) This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake.
c) This is an unanticipated problem, which resulted in an adverse event.
d) The IRB does not have authorization to require changes in the pharmacy procedures.

Answer 1

Answer:

C. This is an unanticipated problem, which resulted in an adverse event.

Explanation: