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
A regulatory affairs professional becomes aware that a colleague has fabricated data in a 510(k) submission. Under ethical obligations, the professional should:
Answer: Report the misconduct through appropriate internal and, if necessary, external channels
Fabricated regulatory data is fraud; the ethical and legal obligation requires escalating through internal reporting mechanisms and, if unresolved, to the FDA.
The RAPS Code of Ethics requires members to maintain 'competence.' Which action best fulfills this obligation?
Answer: Continuously updating knowledge through education, training, and professional development
Ongoing professional development is required to maintain competence as regulations, technologies, and standards continuously evolve.
A regulatory professional working on a combination product faces conflicting guidance from FDA's CDRH and CDER. The most ethically sound approach is to:
Answer: Request formal clarification from the FDA's Office of Combination Products
When facing regulatory ambiguity, seeking official clarification from the designated lead center ensures compliance and integrity.
Which scenario represents a direct violation of the ethical principle of 'objectivity' in regulatory affairs?
Answer: Adjusting risk assessment conclusions to align with management's preferred outcome
Altering scientific or regulatory conclusions to satisfy business preferences violates the objectivity principle by subordinating professional judgment to commercial interests.
An employer asks a regulatory professional to backdate a document to meet a regulatory submission deadline that was missed. The professional should:
Answer: Refuse, as backdating documents constitutes fraud
Backdating regulatory documents is document fraud regardless of the content's accuracy or the business justification.
Under FDA regulations, a regulatory professional who knowingly submits false information in a premarket submission may face:
Answer: Criminal penalties including fines and imprisonment under 18 U.S.C. § 1001
Knowingly submitting false statements to the FDA violates federal law under 18 U.S.C. § 1001, exposing individuals to criminal prosecution.
A regulatory professional serves on a company's ethics committee. Their primary responsibility in that role is to:
Answer: Ensure that ethical standards are applied consistently and impartially across the organization
Ethics committee members must act impartially to uphold organizational integrity, not advocate for any department's business interests.