A spontaneous report arrives with only the patient's initials, the suspect drug, and the adverse event description. Is this a valid ICSR?
-
A
No, because patient age and sex are required
-
B
Yes, if the four minimum elements are present: identifiable patient, identifiable reporter, suspect drug, and adverse event
-
C
No, because the reporter's contact information is missing
-
D
Yes, only if a healthcare professional submitted the report