PVC Individual Case Safety Reports 2

Question 1

Which field in an ICSR is used to capture the outcome of the adverse event at the time of reporting?

Accepted Answer

Reaction outcome

Answer

The reaction outcome field documents whether the patient recovered, is recovering, had sequelae, died, or the outcome is unknown at the time of the report.

Question 2

Under FDA regulations, what is the expedited reporting timeframe for a serious, unexpected, and drug-related adverse event from a clinical trial?

Accepted Answer

15 calendar days

Answer

FDA requires IND safety reports for serious, unexpected adverse drug reactions to be submitted within 15 calendar days of first receiving the information.

Question 3

What distinguishes a 'follow-up' ICSR from an 'initial' ICSR?

Accepted Answer

It contains new or updated information on a previously reported case

Answer

A follow-up ICSR provides additional or corrected information for a case that has already been reported, linked by the same case identifier.

Question 4

Which organization maintains the E2B(R3) standard for electronic ICSR transmission?

Accepted Answer

ICH

Answer

The International Council for Harmonisation (ICH) developed and maintains the E2B guideline specifying the data elements and format for electronic transmission of ICSRs.

Question 5

A spontaneous report received from a healthcare professional describes a patient who experienced anaphylaxis after taking a marketed drug. How should this case be assessed for seriousness?

Accepted Answer

Serious, because it is life-threatening

Answer

Anaphylaxis meets the ICH E2A seriousness criterion of 'life-threatening,' making it a serious adverse event regardless of the outcome.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Individual Case Safety Reports 2