CATO Associate Safety Reporting & Adverse Events Flashcards
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Read the first 6 CATO Associate Safety Reporting & Adverse Events flashcards as text
What is the purpose of a 'Data Safety Monitoring Board' (DSMB) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend continuation, modification, or stopping of the trial
A DSMB (or IDMC) independently monitors accumulating trial data to protect subject safety and can recommend stopping or modifying the trial based on emerging safety signals.
What does it mean for an adverse event to be 'unexpected' in the context of SUSAR reporting?
Answer: The nature, severity, or frequency of the event is not consistent with what is described in the reference safety document (e.g., Investigator Brochure)
An unexpected AE is one whose nature, severity, or frequency is not consistent with current labeling or the Investigator Brochure.
What is a 'sentinel event' in clinical trial safety monitoring?
Answer: A serious and typically unexpected adverse event that signals a potential safety concern requiring immediate investigation
A sentinel event is a serious, usually unexpected adverse outcome that serves as a signal requiring prompt investigation to prevent recurrence or further harm.
Which of the following best describes 'medical coding' of adverse events in clinical trials?
Answer: Assigning standardized terminology codes (e.g., MedDRA) to reported adverse events for consistency in analysis and reporting
Medical coding maps reported adverse events to standardized MedDRA (or similar) terminology for consistent analysis, aggregation, and regulatory submission.
If a subject in a double-blind trial experiences a potentially drug-related SAE, and unblinding is considered, who should make the final medical decision to unblind?
Answer: The treating physician / Principal Investigator in consultation with the sponsor's medical monitor
The decision to unblind for a potentially drug-related SAE should be made by the treating physician/PI in consultation with the sponsor's medical monitor based on medical necessity.
What is the primary goal of pharmacovigilance in clinical trials?
Answer: To detect, assess, understand, and prevent adverse effects or any other drug-related problems
Pharmacovigilance in clinical trials aims to detect, assess, understand, and prevent adverse effects and other drug-related problems to protect subject safety.