Question

A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. The investigator would submit an SAE report for:
A. Neither of the subjects
B. Subject 603 only
C. Subject 20 only
D. Both of the subjects

Answer 1

Answer:

D. Both of the subjects.

Explanation:

Even though these episodes cannot be explained on the basis of the pharmacological properties of the drug being tested or the subjects' medical history, the episodes occurred during study procedures, so it is necessary for the investigator to send an SAE report to both patients, since everything that happens in a study must be reported.