PVC Individual Case Safety Reports 3

Question 1

A company receives a case where the only reporter is a patient who cannot name the specific drug, only describing it as 'a white pill for blood pressure.' Is this a valid ICSR?

Accepted Answer

No, because the specific drug cannot be identified

Answer

A valid ICSR requires an identifiable suspect medicinal product; a vague description insufficient to identify the drug means the minimum dataset is not met.

Question 2

Under EMA regulations, what is the reporting timeframe for a non-serious spontaneous adverse drug reaction for a marketed product?

Accepted Answer

30 days

Answer

EMA regulations require non-serious spontaneous adverse drug reactions for marketed products to be submitted to EudraVigilance within 90 days.

Question 3

Which coding dictionary is most commonly used to code adverse events in ICSRs?

Accepted Answer

MedDRA

Answer

MedDRA (Medical Dictionary for Regulatory Activities) is the international standard used to code adverse events, medical history, and indications in ICSRs.

Question 4

An ICSR is received for a patient who died. The cause of death is listed as the suspect adverse event. What seriousness criterion applies?

Accepted Answer

Results in death

Answer

When a patient dies and the adverse event is the cause, the seriousness criterion 'results in death' is checked, which is one of the defined ICH E2A criteria.

Question 5

What does the term 'de-duplication' refer to in ICSR processing?

Accepted Answer

Identifying and merging cases reported more than once about the same patient event

Answer

De-duplication is the process of identifying ICSRs that represent the same patient event reported through multiple sources and merging them to avoid double-counting.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Individual Case Safety Reports 3