Adverse Event Reporting & Safety Monitoring Flashcards
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An adverse event is classified as 'serious' if it meets which criterion?
Answer: Results in death, is life-threatening, requires hospitalization, or causes persistent disability
Under ICH E6 GCP and 21 CFR 312.32, a serious adverse event (SAE) is defined as one resulting in death, a life-threatening situation, inpatient hospitalization, persistent/significant disability, congenital anomaly, or a medically important event.
What is the FDA expedited reporting timeframe for a fatal or life-threatening unexpected serious adverse drug reaction under an IND?
Answer: 7 calendar days
Under 21 CFR 312.32(c)(1)(i), sponsors must notify FDA within 7 calendar days of a fatal or life-threatening unexpected serious adverse drug reaction.
Which FDA form is used by sponsors and manufacturers to mandatorily report serious adverse events for marketed drugs?
Answer: MedWatch Form 3500A (Mandatory Reporting)
MedWatch Form 3500A is the mandatory reporting form used by manufacturers, distributors, and importers to report SAEs associated with marketed drug and biologic products.
What does the acronym SUSAR stand for in clinical research?
Answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction, referring to a serious reaction that is both unexpected (not in the IB) and considered related to the investigational product.
In clinical research, an adverse event is considered 'unexpected' when it:
Answer: Is not listed in or is inconsistent with the risk information in the Investigator's Brochure
An unexpected adverse event is one whose nature, severity, or frequency is not consistent with or not listed in the current Investigator's Brochure or protocol risk information.
Which independent body is primarily responsible for reviewing accumulating unblinded safety data during a clinical trial and can recommend stopping the trial?
Answer: Data Safety Monitoring Board (DSMB)
The DSMB (Data Safety Monitoring Board), also called a DMC, independently reviews unblinded interim safety and efficacy data and has authority to recommend trial modification, suspension, or termination.
Under 21 CFR 312.32, a non-fatal, non-life-threatening unexpected serious adverse drug reaction must be reported to the FDA within:
Answer: 15 calendar days
Non-fatal and non-life-threatening unexpected serious adverse drug reactions must be submitted to FDA as expedited IND Safety Reports within 15 calendar days per 21 CFR 312.32(c)(1)(ii).