Adverse Drug Reaction Reporting Flashcards
7 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 7 Adverse Drug Reaction Reporting flashcards as text
A spontaneous report arrives with only the patient's initials, the suspect drug, and the adverse event description. Is this a valid ICSR?
Answer: Yes, if the four minimum elements are present: identifiable patient, identifiable reporter, suspect drug, and adverse event
A valid ICSR requires only four minimum elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event/reaction.
Under ICH E2B(R3), what format is used for electronic transmission of ICSRs to regulatory authorities?
Answer: XML following the HL7 ICSR schema
ICH E2B(R3) mandates XML-based electronic transmission of ICSRs using the HL7 structured product labeling ICSR schema.
What is the key difference between a Type A and Type B adverse drug reaction?
Answer: Type A is dose-related and predictable; Type B is idiosyncratic and unpredictable
Type A (Augmented) reactions are pharmacologically predictable and dose-dependent, while Type B (Bizarre) reactions are idiosyncratic, not dose-related, and not predictable from the drug's known mechanism.
Which regulatory authority requires MAHs to submit Periodic Safety Update Reports (PSURs) on a predefined International Birth Date schedule?
Answer: European Medicines Agency (EMA)
The EMA requires PSURs to be submitted according to the EU Single Assessment Procedure aligned with the International Birth Date under ICH E2C(R2).
A clinical trial investigator reports a SAE that is both unexpected and possibly related to the IMP. What document determines 'expectedness' for SUSAR classification?
Answer: The Investigator's Brochure (IB) or Reference Safety Information
Expectedness for SUSAR classification is assessed against the Reference Safety Information, typically the Investigator's Brochure for investigational products.
What is 'dechallenge' in the context of pharmacovigilance causality assessment?
Answer: Stopping or reducing the suspect drug and observing whether the adverse event resolves or improves
Dechallenge refers to stopping or reducing the suspect drug; a positive dechallenge (event improves) supports a causal relationship.
In the Naranjo ADR probability scale, which total score range indicates a 'probable' adverse drug reaction?
Answer: 5 to 8
In the Naranjo scale, a total score of 5–8 indicates a probable ADR, while ≥9 is definite, 1–4 is possible, and ≤0 is doubtful.