CTA Pharmacovigilance & Drug Safety Flashcards
6 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CTA Pharmacovigilance & Drug Safety flashcards as text
What is the FDA's MedWatch program?
Answer: The FDA's safety information and adverse event reporting program for marketed medical products
MedWatch is the FDA's Safety Information and Adverse Event Reporting Program that allows healthcare professionals and the public to report serious adverse events associated with marketed drugs, biologics, and devices.
What is a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: An FDA-required safety program for certain medications with serious risks to ensure benefits outweigh risks
A REMS is an FDA-mandated drug safety program required for certain medications with serious risks, specifying additional measures beyond standard labeling to ensure safe use.
What does causality assessment in pharmacovigilance determine?
Answer: The likelihood that a drug caused a reported adverse event
Causality assessment evaluates the likelihood of a causal relationship between a drug exposure and an adverse event, using algorithms or expert judgment to classify the relationship.
Under 21 CFR 312.32, which type of adverse event requires expedited reporting to the FDA within 15 days?
Answer: Unexpected serious adverse events that are reasonably related to the investigational drug
Unexpected serious adverse events that are reasonably related to the investigational drug (SUSARs) require an expedited 15-day safety report to the FDA under IND regulations.
What is the primary purpose of a pharmacovigilance audit trail?
Answer: To ensure all safety data changes and actions are documented with who made them and when
An audit trail in pharmacovigilance captures a chronological, tamper-evident record of all data entries, changes, and actions taken on safety reports, ensuring data integrity and traceability.
What is a Suspected Unexpected Serious Adverse Reaction (SUSAR)?
Answer: A serious adverse reaction that is both unexpected (not in the IB) and at least possibly related to the investigational product
A SUSAR is a serious adverse reaction that is unexpected (not described in the Investigator's Brochure) and for which there is a reasonable possibility of a causal relationship with the investigational product.