Adverse Event Reporting & Case Management Flashcards
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Which of the following best defines a 'serious adverse event' (SAE) under ICH E2A guidelines?
Answer: An event resulting in death, life-threatening situation, hospitalization, disability, or congenital anomaly
ICH E2A defines an SAE as one resulting in death, life-threatening risk, inpatient hospitalization, persistent disability, congenital anomaly, or a medically important event.
A patient in a clinical trial experiences a hospitalization due to an elective cosmetic procedure. How should this be classified?
Answer: Non-serious adverse event, because elective procedures are excluded from SAE criteria
Elective hospitalizations that were pre-planned and not caused by the investigational product are excluded from SAE seriousness criteria.
Under 21 CFR 312.32, what is the expedited reporting timeframe for an unexpected fatal or life-threatening SUSAR in a US IND?
Answer: 7 calendar days for fatal/life-threatening, 15 calendar days for other unexpected serious events
FDA requires 7-calendar-day reports for fatal or life-threatening unexpected SUSARs and 15-calendar-day reports for other unexpected serious adverse drug reactions.
What is the primary purpose of the MedWatch 3500A form in the US post-marketing pharmacovigilance system?
Answer: To submit mandatory expedited adverse event reports to FDA for marketed products
The MedWatch 3500A (mandatory reporting form) is used by manufacturers, importers, and distributors to submit required expedited safety reports to FDA for marketed products.
In pharmacovigilance case processing, what does 'case narrative' refer to?
Answer: A concise medical summary of all relevant information in an individual case safety report
A case narrative is a concise, chronological medical summary that synthesizes all relevant information from an ICSR into a coherent clinical account.
Which regulatory database is used to submit Individual Case Safety Reports (ICSRs) to the FDA for marketed products?
Answer: FDA Adverse Event Reporting System (FAERS)
FAERS (FDA Adverse Event Reporting System) is the FDA's database that receives and manages ICSRs for marketed products in the US.
When a spontaneous adverse event report is received with incomplete patient information, what is the minimum dataset required to make it a valid case for submission?
Answer: An identifiable patient, an identifiable reporter, a suspect product, and at least one adverse event
The four minimum criteria for a valid ICSR are: an identifiable patient, an identifiable reporter, at least one suspect medicinal product, and at least one adverse event.