Clinical Trials & Post-Marketing Surveillance 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 Clinical Trials & Post-Marketing Surveillance flashcards as text
A company receives a serious adverse event report for an off-label use of their product. Are they obligated to include it in their pharmacovigilance reporting?
Answer: Yes, serious ADRs regardless of whether use is on- or off-label must be reported
Marketing authorization holders must report serious ADRs associated with their product regardless of whether the use was within the approved indication.
What is the primary purpose of the Clinical Study Report (CSR) Integrated Summary of Safety (ISS) in a New Drug Application?
Answer: To provide a comprehensive integrated analysis of safety data across all studies
The ISS integrates safety data across the full clinical development program to present a complete picture of the drug's safety profile to regulators.
In the context of post-marketing surveillance, what is 'pharmacovigilance system master file' (PSMF)?
Answer: A document describing the pharmacovigilance system of the marketing authorization holder
The PSMF is an EU-required master document that provides a detailed description of the pharmacovigilance system used by the marketing authorization holder.
Which term describes a drug interaction where one drug alters the metabolism of another by inhibiting a CYP450 enzyme, leading to increased plasma levels and potential toxicity?
Answer: Pharmacokinetic drug-drug interaction
CYP450 inhibition alters the pharmacokinetics of co-administered drugs, a key source of clinically significant drug-drug interactions monitored in pharmacovigilance.
Under the FDA's Expanded Access (compassionate use) program, which type of safety reporting applies to individual patients receiving an investigational drug?
Answer: IND safety reporting rules apply, requiring serious unexpected adverse event reports
Expanded access use is conducted under an IND, so the full IND safety reporting requirements, including SUSAR expedited reporting, apply.
A drug's benefit-risk profile is re-evaluated following a cluster of fatal hepatic events. Which regulatory action represents the most restrictive outcome while keeping the drug on the market?
Answer: Implementation of a Risk Evaluation and Mitigation Strategy (REMS) with ETASU
REMS with Elements to Assure Safe Use (ETASU) impose mandatory restrictions on prescribing, dispensing, or patient monitoring, representing the most restrictive tool short of withdrawal.
When assessing causality in an individual adverse event case, which algorithm is most widely used internationally in spontaneous pharmacovigilance reporting?
Answer: WHO-UMC Causality Assessment System
The WHO-UMC causality assessment system (certain/probable/possible/unlikely) is the standard used by WHO's global pharmacovigilance database VigiBase.