Patient Safety & Risk 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 Patient Safety & Risk Management flashcards as text
A clinical trial site implements a double-check system for investigational product dispensing. This is an example of which patient safety concept?
Answer: Redundancy as a defense-in-depth strategy
Defense-in-depth uses layered redundant checks so that if one safeguard fails, another catches the error before it reaches the patient.
Which of the following BEST describes the purpose of an Institutional Review Board (IRB) continuing review in the context of patient safety?
Answer: To assess ongoing risks to participants in light of accumulated safety data and ensure protections remain adequate
Continuing review allows the IRB to evaluate evolving risk-benefit profiles based on new safety information and adjust participant protections accordingly.
An investigator observes an unexpected cluster of similar adverse events among participants in the same treatment arm. What action should the investigator take FIRST?
Answer: Immediately report the potential safety signal to the sponsor and IRB for evaluation
Clusters of similar adverse events may indicate a safety signal that requires prompt escalation to the sponsor and IRB for assessment.
In risk management for clinical research, what does 'residual risk' mean?
Answer: The level of risk that remains after all risk mitigation measures have been implemented
Residual risk is the remaining risk after controls are applied; it must be acceptable relative to anticipated benefits for the trial to proceed.
A participant enrolled in a placebo-controlled trial develops symptoms strongly suggesting they are in the control arm. They request unblinding to pursue open-label treatment. What should the investigator do?
Answer: Follow the protocol's unblinding procedures, which typically require a clinical safety justification and sponsor notification
Emergency unblinding should follow predefined protocol procedures requiring clinical justification, protecting both safety and data integrity.
Which of the following is a PROACTIVE patient safety tool used before a clinical trial begins to identify potential failure points?
Answer: Failure mode and effects analysis (FMEA)
FMEA is performed prospectively to identify and prioritize potential failure modes before trial initiation, unlike RCA which is retrospective.
An investigational drug trial site experiences a fire drill that disrupts temperature-controlled storage, potentially compromising investigational product integrity. What is the correct response regarding patient safety?
Answer: Quarantine the potentially compromised product, notify the sponsor, and follow the protocol's temperature excursion procedures before any further dispensing
Temperature excursions require quarantine and sponsor notification to assess product viability before dispensing, protecting participants from potentially degraded study drug.