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 receives an urgent safety communication from the sponsor indicating that a new risk of liver toxicity has been identified. What is the investigator's IMMEDIATE obligation?
Answer: Review the communication, notify the IRB, and assess currently enrolled participants per sponsor guidance
The investigator must promptly review new safety information, report it to the IRB, and implement any required monitoring or protocol changes to protect participants.
In clinical research, which of the following BEST describes the 'blame-free' culture essential to patient safety?
Answer: Errors are reported without fear of punishment so systemic problems can be identified and fixed
A blame-free culture encourages transparent reporting by ensuring that individuals can report errors without fear of punitive consequences, enabling system improvement.
A pediatric clinical trial participant's parent reports that the child accidentally ingested a double dose of the investigational product. How should this be classified?
Answer: A potential adverse event requiring immediate clinical assessment and documentation
Overdose of an investigational product is an adverse event requiring clinical evaluation, documentation, and notification to the sponsor.
Which failure mode is MOST commonly identified in clinical trials through a Failure Mode and Effects Analysis (FMEA)?
Answer: Process steps that could lead to participant harm if they fail
FMEA proactively identifies process steps where failure could harm participants, allowing risk mitigation before the trial begins.
A clinical investigator notices that several participants are not properly completing the study diary, leading to incomplete safety data. What is the BEST course of action?
Answer: Re-train participants on diary completion and document the retraining
Retraining and documenting the effort ensures data integrity while maintaining participant safety monitoring through complete records.
Under 21 CFR Part 312, which of the following adverse events requires expedited 15-day reporting by the sponsor to the FDA?
Answer: Unexpected serious adverse events that are reasonably related to the investigational drug
Unexpected serious adverse drug reactions that may be causally related to the investigational product require expedited 15-day reporting to FDA under 21 CFR 312.32.
A site coordinator discovers that a participant was enrolled despite not meeting a key inclusion criterion. What type of issue is this, and who must be notified?
Answer: A protocol deviation; the IRB and sponsor must be notified per site SOPs
Enrollment of an ineligible participant is a protocol deviation that may affect participant safety and data integrity, requiring IRB and sponsor notification.