Adverse Event Reporting & Case Management Flashcards
6 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Adverse Event Reporting & Case Management flashcards as text
Which of the following is considered a serious adverse event (SAE)?
Answer: Hospitalization due to severe allergic reaction
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes significant disability.
What is the minimum required information to consider a valid Individual Case Safety Report (ICSR)?
Answer: Four minimum criteria: reporter, patient, event, drug
A valid ICSR must include four elements: an identifiable reporter, an identifiable patient, a suspected adverse event, and a suspected drug.
Which coding system is primarily used to classify adverse events in pharmacovigilance?
Answer: MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is the standard terminology used globally to code and classify adverse events.
Who is responsible for reporting adverse events in post-marketing surveillance?
Answer: Healthcare providers, patients, and manufacturers
Healthcare professionals, patients, and the Marketing Authorization Holder (MAH) all play roles in reporting adverse events after a drug is marketed.
What is the appropriate timeline for reporting a fatal adverse drug reaction to regulatory authorities?
Answer: 7 calendar days
A fatal adverse drug reaction must be reported within 7 calendar days according to international pharmacovigilance guidelines.
In a clinical trial setting, who is typically responsible for initial adverse event reporting?
Answer: Trial investigator
Investigators are responsible for identifying and reporting adverse events to the sponsor during clinical trials.