- Society of Clinical Research Associates Adverse Event Safety Reporting Questions and Answers Flashcards
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Read the first 6 - Society of Clinical Research Associates Adverse Event Safety Reporting Questions and Answers flashcards as text
What is the timeframe for reporting unexpected fatal or life-threatening suspected adverse reactions to the FDA?
Answer: 7 calendar days
Per 21 CFR 312.32, sponsors must report these within 7 calendar days.
What is the difference 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
An AE is any untoward medical occurrence regardless of causal relationship; an ADR implies at least a reasonable possibility of causal relationship.
What information must be included in an expedited safety report?
Answer: Patient identification, event description, suspect drug information, reporter information, and causality assessment
Reports must include patient identification, detailed event description, suspect drug information, reporter details, and causality assessment.
What is a SUSAR and why is it significant?
Answer: A Suspected Unexpected Serious Adverse Reaction requiring expedited reporting
A SUSAR is a serious adverse reaction that is suspected, unexpected, and requires expedited reporting.
What is the role of pharmacovigilance during a clinical trial?
Answer: Collect, assess, and report safety data throughout the trial lifecycle
Pharmacovigilance is responsible for systematic collection, detection, assessment, monitoring, and prevention of adverse effects.
What is a Development Safety Update Report (DSUR)?
Answer: An annual report providing comprehensive safety analysis during drug development
A DSUR is an annual report providing comprehensive safety analysis of information collected during the reporting period.
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