Regulatory Compliance & Ethical Standards 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 Regulatory Compliance & Ethical Standards flashcards as text
A participant in a Phase II oncology trial loses decision-making capacity mid-study after enrollment. What is the APPROPRIATE next step?
Answer: Seek consent from a legally authorized representative (LAR) and assess whether continued participation is in the participant's best interest
When a participant loses capacity, a LAR must provide permission for continued participation, and the investigator must assess whether continued participation benefits or harms the participant.
Under ICH E6(R2), the sponsor is responsible for implementing a risk-based monitoring approach. What does this primarily mean for site monitoring?
Answer: Monitoring activities should be proportionate to the identified risks to participant safety and data integrity
ICH E6(R2) introduced risk-based monitoring, requiring sponsors to tailor the frequency and nature of monitoring to actual trial risks rather than applying one-size-fits-all approaches.
When must an investigator obtain a new or revised informed consent from an already-enrolled participant?
Answer: When the IRB approves a protocol amendment that contains information that might affect a participant's willingness to continue
Re-consent is required when new information emerges (such as new risks) that might affect participants' decisions about continued participation in the trial.
The Nuremberg Code, as a foundational document in research ethics, established which paramount requirement for human research?
Answer: The voluntary consent of the human subject is absolutely essential
The first and most important principle of the Nuremberg Code is that voluntary consent of the human subject is absolutely essential to ethical research.
An investigational drug is accidentally administered to a participant at twice the protocol-specified dose. This event results in hospitalization. How should this be classified?
Answer: Serious adverse event requiring expedited reporting to IRB and sponsor
Hospitalization resulting from a medication error meets the definition of a serious adverse event (SAE), requiring expedited reporting to both the sponsor and IRB.
Under the Common Rule (45 CFR 46), which population requires ADDITIONAL regulatory protections because they are considered 'vulnerable subjects'?
Answer: Prisoners, pregnant women, and children
The Common Rule identifies prisoners (Subpart C), pregnant women/fetuses (Subpart B), and children (Subpart D) as vulnerable populations requiring additional protections.
A CPI is reviewing a research proposal that offers $500 per visit to participants in a 10-visit study. Which ethical concern is MOST relevant?
Answer: Excessive payment may constitute undue inducement, compromising voluntariness of consent
Undue inducement occurs when payment is so large that it compromises participants' ability to freely weigh risks and benefits, threatening the voluntariness of consent.