CPI Adverse Event Management & Reporting Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Adverse Event Management & Reporting flashcards as text
Which of the following meets the FDA definition of a Serious Adverse Event (SAE) in a clinical trial?
Answer: Hospitalization required due to a study-related complication
An SAE is any adverse event that results in death, life-threatening risk, hospitalization, disability, congenital anomaly, or requires medical intervention to prevent serious outcomes.
Within what timeframe must an investigator report a fatal or life-threatening unexpected SAE to the FDA under 21 CFR 312.32?
Answer: Within 7 calendar days
Fatal or life-threatening unexpected serious adverse drug reactions must be reported to the FDA as an IND safety report within 7 calendar days of the investigator becoming aware.
What does it mean for an adverse drug reaction to be 'unexpected' in a clinical trial context?
Answer: The nature, severity, or specificity is not consistent with what is described in the Investigator's Brochure
An unexpected adverse reaction is one whose nature, severity, or specificity is not consistent with the current Investigator's Brochure or product labeling.
Which form is used to report post-market safety problems with FDA-regulated products to the FDA?
Answer: FDA MedWatch Form 3500
MedWatch Form 3500 (voluntary) or 3500A (mandatory for industry) is the FDA's safety reporting form for adverse events with regulated products.
What is the key distinction between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR)?
Answer: An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship to the study drug
An adverse event is any unfavorable occurrence during a study regardless of drug relationship, while an adverse drug reaction implies a reasonable causal relationship to the investigational product.
Who is primarily responsible for reporting SAEs to the clinical trial sponsor?
Answer: The principal investigator or sub-investigator at the site
The principal investigator is responsible for promptly reporting all SAEs to the sponsor, who then evaluates and submits required safety reports to the FDA.