Ethics & Professional Responsibilities Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Ethics & Professional Responsibilities flashcards as text
Which of the following best illustrates the ethical principle of 'respect for persons' in regulatory affairs?
Answer: Ensuring informed consent processes are rigorous and participant rights are protected
Respect for persons requires that human subjects in clinical research are fully informed and their autonomy and rights are protected throughout.
A regulatory professional learns that a former employer is engaging in regulatory fraud. Their obligation under the RAPS Code of Ethics is to:
Answer: Consider reporting to appropriate authorities, balancing confidentiality obligations with public safety
Even post-employment, ethical obligations may require reporting regulatory fraud, balanced carefully against legitimate confidentiality duties.
In the context of regulatory affairs, 'due diligence' most closely relates to which ethical obligation?
Answer: Thoroughly verifying the accuracy and completeness of regulatory submissions and decisions
Due diligence requires regulatory professionals to verify accuracy and completeness independently, ensuring submissions faithfully represent the underlying evidence.
A regulatory professional who is also a member of a professional society volunteers to review a colleague's manuscript. They realize the manuscript describes a competitor's unreported product strategy. The ethical action is to:
Answer: Maintain confidentiality of the reviewed material and recuse if there is a conflict of interest
Peer review is confidential; using or disclosing reviewed material for personal or competitive advantage violates both reviewer ethics and confidentiality obligations.
Under 21 CFR Part 11, a regulatory professional's ethical obligations regarding electronic records include:
Answer: Ensuring audit trails are accurate, complete, and protected from unauthorized alteration
21 CFR Part 11 compliance requires that electronic records and audit trails are complete, accurate, and cannot be altered without detection.
When a regulatory professional identifies that their company's quality system has a systemic gap that could affect product safety, the most ethical course of action is to:
Answer: Escalate the finding through the corrective and preventive action (CAPA) system immediately
Systemic quality gaps require immediate escalation through the CAPA system to prevent recurrence and protect patient safety.
A regulatory professional is pressured by senior leadership to certify that a post-market surveillance report is complete when known data gaps exist. The most ethical response is to:
Answer: Refuse to certify and provide a written explanation of the identified data gaps
Certifying an incomplete report constitutes a false attestation; the professional must refuse and formally document the deficiencies.