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 pharmacovigilance?
Answer: The science and activities related to detection, assessment, understanding, and prevention of adverse effects of medicines
Pharmacovigilance encompasses the activities designed to detect, assess, understand, and prevent adverse effects or any other drug-related problems throughout the product lifecycle.
What is a Serious Adverse Event (SAE) in clinical trials according to ICH E6?
Answer: An event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly
Per ICH E6, an SAE is any adverse event that results in death, is life-threatening, requires inpatient hospitalization, causes persistent disability, or is a congenital anomaly/birth defect.
What differentiates an adverse event (AE) from an adverse drug reaction (ADR)?
Answer: An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship to the drug
An AE is any undesirable event regardless of suspected causality to the drug, while an ADR requires that a causal relationship to the drug is at least a reasonable possibility.
What is an Investigational New Drug (IND) safety report?
Answer: A report submitted to the FDA about unexpected serious adverse reactions that may affect participant safety
IND safety reports are expedited reports submitted to the FDA when there is a suspected unexpected serious adverse reaction (SUSAR) or new safety information that could affect participant safety or alter the trial conduct.
What is the timeframe for reporting a fatal or life-threatening unexpected SUSAR to the FDA under IND regulations?
Answer: 7 calendar days
Under 21 CFR 312.32, fatal or life-threatening unexpected SUSARs must be reported to the FDA within 7 calendar days of the sponsor's initial receipt of the information.
What does 'unexpected' mean in the context of a Suspected Unexpected Serious Adverse Reaction (SUSAR)?
Answer: The adverse reaction is not consistent in nature or severity with the Investigator's Brochure or product labeling
An adverse reaction is considered unexpected when its nature, severity, or frequency is not consistent with or not listed in the current Investigator's Brochure or approved product labeling.