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
An investigator is also a treating physician for a potential study participant. Which conflict of interest concern is MOST relevant to informed consent?
Answer: The dual role may impair the participant's ability to freely decline or withdraw without fearing impact on their clinical care
The therapeutic misconception and fear of jeopardizing ongoing care can compromise voluntariness when the treating physician is also the investigator.
Under 45 CFR Part 46, research that qualifies for exemption under Category 1 involves which type of participants?
Answer: Normal educational practices in established educational settings
Category 1 exemption applies to research involving normal educational practices in established educational settings.
When a clinical trial requires a HIPAA Authorization, which of the following is a required element that distinguishes it from a general informed consent form?
Answer: A list of the types of protected health information to be used or disclosed
HIPAA Authorization must specifically describe the protected health information (PHI) to be used or disclosed, which is distinct from general informed consent requirements.
A clinical trial site receives a sponsor audit. The auditor finds that source documents are missing for 3 participants. What is the regulatory implication?
Answer: Missing source documents constitute a data integrity failure that may trigger FDA inspection and clinical hold
Missing source documents undermine data integrity and verifiability, and can result in sponsor corrective actions, FDA inspection, or rejection of submitted data.
The principle of justice in the Belmont Report specifically addresses which of the following research ethics concerns?
Answer: Fair distribution of the burdens and benefits of research across population groups
Justice requires equitable selection of research subjects so that no group bears a disproportionate burden or is systematically excluded from benefits.
Under 21 CFR 50.25, which of the following is classified as an ADDITIONAL element of informed consent (rather than a basic required element)?
Answer: Disclosure that a particular treatment or procedure may involve currently unforeseeable risks to a participant or embryo if pregnant
The disclosure of unforeseeable risks to participants or embryos is listed under 21 CFR 50.25(b) as an additional element, not a basic required one.
Which action is considered a SERIOUS GCP violation that would most likely trigger an FDA Warning Letter to an investigator?
Answer: Enrolling participants who did not meet eligibility criteria and falsifying screening data
Falsifying screening data and enrolling ineligible participants constitutes research fraud and data integrity failure, the most serious GCP violation triggering FDA enforcement action.