Adverse Event Reporting & Case Management Flashcards
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Read the first 7 Adverse Event Reporting & Case Management flashcards as text
A company's drug is approved in both the US and EU. A serious unexpected adverse reaction is reported from a Japanese patient on compassionate use. Which regions must receive an expedited ICSR?
Answer: All regions where the product is approved or under investigation, as per ICH E2D
Under ICH E2D, serious unexpected adverse drug reactions must be reported expeditiously to all regulatory authorities where the product is approved or under clinical investigation.
Which of the following scenarios would NOT trigger an expedited 15-day safety report to the FDA for a marketed product?
Answer: A report from a post-marketing study showing a serious expected adverse reaction
Serious adverse events that are expected (listed in the product labeling) from post-marketing studies do not require 15-day expedited reporting; they are submitted in periodic reports.
What is a 'SUSAR' and in what regulatory context is the term most commonly used?
Answer: Suspected Unexpected Serious Adverse Reaction — used primarily in clinical trial (IND) pharmacovigilance reporting
SUSAR stands for Suspected Unexpected Serious Adverse Reaction and is the term used in the clinical trial context to identify cases requiring expedited reporting to regulatory authorities and ethics committees.
During case triage, a safety associate receives a report of a patient death after product use. The reporter cannot confirm whether the patient was taking the company's drug. What is the correct action?
Answer: Process as a valid case requiring expedited reporting because a fatal event is described with minimum criteria met
If minimum criteria are met (identifiable patient, reporter, adverse event, and suspect product — even if unconfirmed), the case must be processed and reported; death triggers expedited reporting regardless of causality confirmation.
What is the role of the EU Individual Case Safety Report gateway (EudraVigilance) in post-marketing pharmacovigilance?
Answer: It is the EMA's database and electronic reporting system for receiving ICSRs for products authorized in the European Economic Area
EudraVigilance is the EMA's system for collecting and analyzing ICSRs related to medicinal products authorized or being studied in the EEA.
A pharmacovigilance officer identifies that a case initially entered as non-serious should have been classified as serious. The 15-day reporting clock has not yet expired. What is the correct action?
Answer: Reclassify the case and submit it as a serious expedited report within the original 15-day clock from day 0
When a case is reclassified to serious, the original Day 0 is retained and the 15-day expedited reporting clock continues from that date — reclassification does not reset the clock.
Which MedDRA hierarchy level is primarily used for signal detection and regulatory reporting in individual case safety reports?
Answer: Preferred Term (PT)
The Preferred Term (PT) is the primary level used for coding and reporting adverse events in ICSRs, as it represents a distinct medical concept at the appropriate level of specificity.