Adverse Events Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Adverse Events flashcards as text
What is the key difference between 'intensity' and 'causality' when assessing an adverse event?
Answer: Intensity describes severity (mild/moderate/severe); causality describes the relationship to the study drug
Intensity (severity) describes how severe the event is, while causality assesses the likelihood that the event is related to the investigational product.
What is 'unmasking' or 'unblinding' in the context of SAE reporting?
Answer: Revealing the subject's treatment assignment to assess causality for an SAE
Unblinding for an SAE involves revealing the subject's treatment assignment (active vs. placebo) to allow proper causality assessment while maintaining blind for others.
Under 21 CFR 312.32, what is the reporting timeframe for serious, unexpected AEs that are NOT fatal or life-threatening?
Answer: 15 calendar days
Non-fatal, non-life-threatening unexpected serious adverse drug reactions must be reported to the FDA within 15 calendar days under 21 CFR 312.32.
What is a 'follow-up report' in the context of adverse event reporting?
Answer: An updated report submitted when new information about a previously reported SAE becomes available
A follow-up report is submitted when new information (such as outcome, additional lab results, or revised causality) becomes available for a previously reported expedited SAE.
What does 'medical monitoring' of adverse events involve in a clinical trial?
Answer: Ongoing review of safety data by a qualified medical professional to detect safety signals
Medical monitoring involves a sponsor's qualified medical professional continuously reviewing safety data to identify potential safety signals and protect participant safety.
What is the purpose of collecting 'concomitant medications' data during a clinical trial?
Answer: To assess potential drug interactions and confounding effects on safety and efficacy outcomes
Collecting concomitant medication data allows detection of potential drug-drug interactions that could confound efficacy results or contribute to observed adverse events.