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
An investigator's site is preparing for a trial involving a high-risk investigational device. Which risk mitigation strategy is MOST appropriate during the startup phase?
Answer: Conducting a thorough hazard analysis and developing site-specific safety SOPs
A hazard analysis and site-specific safety SOPs proactively identify and control risks before participant exposure begins.
In the context of patient safety in clinical trials, what does the term 'sentinel event' refer to?
Answer: An unexpected occurrence involving death or serious physical harm that signals a need for immediate investigation
A sentinel event is an unanticipated event involving death or serious harm that demands immediate root cause analysis and corrective action.
Which document PRIMARILY governs the responsibilities of a clinical investigator regarding participant safety at a US site?
Answer: FDA Form 1572 and the investigational plan/protocol
FDA Form 1572 and the protocol define the investigator's commitments to conduct the study according to regulations and ensure participant safety.
A participant withdraws consent mid-trial citing discomfort with study procedures. What is the investigator's responsibility regarding safety follow-up?
Answer: Offer appropriate medical follow-up for any ongoing safety concerns, with the participant's agreement
Even after withdrawal, investigators should offer safety follow-up for any ongoing adverse events, respecting the participant's autonomy while protecting their welfare.
What is the primary reason for maintaining accurate and contemporaneous source records in a clinical trial?
Answer: To provide a verifiable audit trail that ensures data integrity and supports patient safety oversight
Contemporaneous source records create an auditable trail that allows verification of safety data, supports regulatory review, and ensures accountability.
A clinical trial involves a vulnerable population (cognitively impaired adults). Which additional patient safety safeguard is MOST important?
Answer: Requiring a legally authorized representative to provide consent and monitoring for signs of undue influence
Vulnerable populations require heightened protections, including surrogate consent from a legally authorized representative and vigilance against coercion.
During a monitoring visit, a sponsor's clinical research associate (CRA) finds undocumented protocol deviations that may have affected participant safety. What is the MOST appropriate next step?
Answer: Document the findings in the monitoring report and work with the investigator to implement corrective and preventive actions (CAPAs)
Monitoring findings must be documented and addressed through formal CAPA processes to correct deficiencies and prevent recurrence.