Risk Assessment & Management Flashcards
7 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 7 Risk Assessment & Management flashcards as text
Which type of risk assessment examines potential failures in study processes by asking 'what could go wrong at each step'?
Answer: Failure Mode and Effects Analysis (FMEA)
FMEA systematically evaluates each process step to identify potential failure modes, their effects, and their causes to prioritize risk controls.
A sponsor conducting risk-based monitoring (RBM) focuses audit resources on:
Answer: Sites and data points with the highest identified risk
Risk-based monitoring concentrates oversight resources on sites, processes, and data points that present the greatest risk to participant safety and data integrity.
When a protocol specifies stopping rules for interim analyses, these rules primarily serve to:
Answer: Control the overall Type I error rate across multiple analyses
Pre-specified stopping rules (alpha spending functions) control the inflation of Type I error that would result from repeatedly testing accumulating data.
A principal investigator who identifies a conflict of interest related to study funding MUST:
Answer: Disclose the conflict to the IRB and institution
Federal regulations and institutional policies require investigators to disclose financial conflicts of interest to their IRB and institution for management, not necessarily automatic recusal.
In qualitative risk assessment, risks characterized as 'High Probability / Low Impact' are typically:
Answer: Actively mitigated because their frequency makes cumulative impact significant
Frequent low-impact risks can accumulate to cause significant operational disruption and should be mitigated even if individual occurrences seem minor.
Which of the following BEST describes a 'risk owner' in a research study risk management framework?
Answer: The individual responsible for monitoring and responding to a specific risk
A risk owner is assigned accountability for monitoring a specific risk and ensuring that mitigation or contingency actions are carried out effectively.
An unexpected serious adverse event (USAE) must be reported to the FDA within how many calendar days when it is both serious and unexpected?
Answer: 7 days for fatal/life-threatening; 15 days for other serious unexpected
21 CFR 312.32 requires expedited reporting within 7 calendar days for fatal or life-threatening unexpected SAEs and 15 days for other serious unexpected adverse drug reactions.