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
In the context of research risk management, 'sensitivity analysis' is used to:
Answer: Determine how much study outcomes change when key assumptions are varied
Sensitivity analysis tests how robust conclusions are by systematically varying uncertain inputs or assumptions to see their effect on outcomes.
A Corrective and Preventive Action (CAPA) plan is BEST described as:
Answer: A documented response that addresses the cause of a deviation and prevents recurrence
A CAPA plan documents actions to correct an identified problem (corrective) and eliminate the underlying cause to prevent future recurrence (preventive).
Which of the following is an example of a 'positive risk' (opportunity) in research project management?
Answer: Faster-than-expected enrollment enabling earlier study completion
Faster enrollment is a positive risk (opportunity) because it can accelerate timelines and reduce costs, and should be actively exploited.
When assessing risks associated with vulnerable populations in research, the IRB must give particular attention to:
Answer: Whether additional safeguards are in place to protect those who may be less able to protect themselves
The Common Rule requires IRBs to ensure additional protections are in place for vulnerable populations who may have diminished autonomy or be susceptible to coercion.
A 'risk threshold' in study management is defined as:
Answer: The level of risk exposure above which action is required
A risk threshold is the predefined level of risk exposure that triggers a required response or escalation, distinguishing acceptable from unacceptable risk levels.
The ICH E6(R2) guidance on Good Clinical Practice emphasizes a risk-based approach primarily to:
Answer: Focus quality efforts on activities most critical to participant protection and data reliability
ICH E6(R2) introduced a risk-proportionate approach directing that quality oversight be concentrated where it matters most—participant safety and critical data.
When a risk cannot be mitigated below an acceptable threshold and cannot be avoided or transferred, the risk management response of last resort is:
Answer: Risk acceptance with documented rationale and monitoring
Risk acceptance is the deliberate, documented decision to proceed despite a risk when all other responses are infeasible, paired with ongoing monitoring.