Individual Case Safety Reports Flashcards
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Read the first 7 Individual Case Safety Reports flashcards as text
Which ICH guideline specifically addresses the content and format of individual case safety reports for marketed products?
Answer: ICH E2D
ICH E2D provides guidance on post-approval safety data management, specifically covering the definition, processing, and reporting of ICSRs for marketed products.
A patient reports that she experienced a rash that resolved on stopping the drug (dechallenge positive) but returned when the drug was restarted (rechallenge positive). What is the most appropriate WHO-UMC causality category?
Answer: Certain
Positive dechallenge combined with positive rechallenge is the hallmark of the 'Certain' WHO-UMC causality category, providing the strongest evidence of a causal drug-event relationship.
What is the purpose of the 'medical confirmation' flag in an ICSR?
Answer: To denote that a healthcare professional has confirmed the adverse event details
The medical confirmation flag indicates that a healthcare professional (such as a physician or pharmacist) has verified or provided information about the case, which may affect reporting obligations.
Which of the following is NOT a recognized seriousness criterion under ICH E2A?
Answer: Results in significant pain
Significant pain is not a defined ICH E2A seriousness criterion; the recognized criteria are death, life-threatening, hospitalization, disability/incapacity, congenital anomaly, and medical significance.
When a company receives an ICSR from a patient support program it sponsors, how should the case be classified?
Answer: Solicited report
Reports from company-sponsored patient support programs are classified as solicited because they arise from an organized data-collection scheme, not voluntary unsolicited reporting.
In E2B(R3), what does the data element 'G.k.4.r.1a' typically capture?
Answer: Dose of the suspect drug
The G.k.4.r.1a data element captures the dose of the suspect or interacting drug as part of the drug dosage information block in E2B(R3).
A pharmacovigilance professional must decide if an event reported by a consumer meets the threshold for expedited reporting. The event is 'nausea leading to a two-day hospitalization.' What is the correct assessment?
Answer: Serious — hospitalization fulfills an ICH E2A seriousness criterion regardless of the event type
Inpatient hospitalization is an ICH E2A seriousness criterion; once hospitalization occurs, the case is serious regardless of the underlying event type or its perceived severity.