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 root cause analysis (RCA) of a medication error in a clinical trial reveals that a nurse administered the wrong dose because of an illegible handwritten order. What is the MOST appropriate systemic corrective action?
Answer: Implement electronic order entry to eliminate handwritten prescriptions
Systemic solutions such as electronic order entry address the root cause by eliminating illegible handwriting rather than placing blame on individuals.
Under ICH E6(R2) guidelines, what is the principal investigator's responsibility when a serious adverse event (SAE) occurs in a clinical trial?
Answer: Notify the sponsor immediately and complete required documentation
ICH E6(R2) requires the PI to promptly notify the sponsor of SAEs so the sponsor can fulfill regulatory reporting obligations.
A participant in a drug trial develops an unexpected anaphylactic reaction. After stabilizing the patient, what is the FIRST documentation step the investigator should take?
Answer: Complete an SAE report form documenting the event details
Timely and accurate documentation in the SAE report form is the first required step after ensuring participant safety.
Which strategy is MOST effective in reducing protocol deviations related to patient safety in clinical trials?
Answer: Providing comprehensive staff training and protocol-specific procedures
Comprehensive staff training and clear SOPs reduce misunderstandings that lead to protocol deviations affecting safety.
In a clinical trial, a near-miss event occurs when a pharmacist catches a wrong-drug dispensing error before the participant receives it. What should be done with this near-miss?
Answer: Document and report it through the site's safety reporting system
Near-misses must be documented and analyzed because they reveal latent system failures that can lead to future harm.
A clinical trial participant who is enrolled in a study on an experimental anticoagulant is scheduled for an elective dental procedure. What is the investigator's primary responsibility?
Answer: Coordinate communication between the dentist and the study team regarding investigational drug interactions
The investigator must facilitate communication between treating providers to ensure safe management of concomitant procedures involving investigational agents.
What is the purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend stopping or modifying the trial if necessary
The DSMB serves as an independent oversight body that can recommend trial modification or termination based on interim safety and efficacy reviews.