Individual Case Safety Reports Flashcards
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Read the first 7 Individual Case Safety Reports flashcards as text
Which field in an ICSR is used to capture the outcome of the adverse event at the time of reporting?
Answer: Reaction outcome
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.
Under FDA regulations, what is the expedited reporting timeframe for a serious, unexpected, and drug-related adverse event from a clinical trial?
Answer: 15 calendar days
FDA requires IND safety reports for serious, unexpected adverse drug reactions to be submitted within 15 calendar days of first receiving the information.
What distinguishes a 'follow-up' ICSR from an 'initial' ICSR?
Answer: It contains new or updated information on a previously reported case
A follow-up ICSR provides additional or corrected information for a case that has already been reported, linked by the same case identifier.
Which organization maintains the E2B(R3) standard for electronic ICSR transmission?
Answer: ICH
The International Council for Harmonisation (ICH) developed and maintains the E2B guideline specifying the data elements and format for electronic transmission of ICSRs.
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?
Answer: Serious, because it is life-threatening
Anaphylaxis meets the ICH E2A seriousness criterion of 'life-threatening,' making it a serious adverse event regardless of the outcome.
What is the minimum dataset required to consider a spontaneous adverse event report a 'valid' ICSR?
Answer: Reporter, patient initials, suspect drug, adverse event
ICH E2D defines the four minimum elements for a valid ICSR: an identifiable reporter, an identifiable patient, a suspect drug, and at least one adverse event.
Which narrative section of an ICSR summarizes the clinical course of the adverse event and is required in E2B(R3) submissions?
Answer: H.1 – Case narrative
The H.1 field in E2B(R3) contains the case narrative, which provides a free-text summary of the clinical course, relevant medical history, and assessment.