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 professional is representing a sponsor in meetings with the FDA. Which behavior best reflects ethical professional conduct?
Answer: Presenting complete and accurate information while representing the sponsor's interests
Ethical representation involves presenting complete information truthfully while legitimately advocating for the client's position.
In regulatory affairs, the term 'whistleblower protection' most directly relates to which ethical principle?
Answer: Integrity and non-retaliation
Whistleblower protections reinforce integrity by ensuring individuals can report misconduct without fear of retaliation.
A regulatory consultant is engaged by multiple competing medical device companies. The primary ethical obligation is to:
Answer: Maintain strict confidentiality and disclose the conflict of interest to all relevant parties
Consultants must maintain confidentiality for each client and proactively disclose any conflicts of interest to preserve trust and professional integrity.
Which of the following constitutes a breach of confidentiality for a regulatory affairs professional?
Answer: Disclosing a client's proprietary formulation to a competitor during contract negotiations
Disclosing a client's proprietary information to any unauthorized party, including competitors, is a direct breach of confidentiality obligations.
When a regulatory professional disagrees with a management decision they believe poses a public health risk, the most ethical course of action is to:
Answer: Document the disagreement formally and escalate through appropriate channels
Formal documentation and internal escalation provides a record of the professional's concern while following appropriate channels before external disclosure.
The RAPS Code of Ethics applies to RAPS members in which context?
Answer: In all professional activities, including consulting, volunteering, and representing RAPS
The RAPS Code of Ethics applies to members across all professional activities, not just primary employment, as it governs the professional's conduct broadly.
A regulatory professional is asked to sign off on a risk management file they did not personally review. The ethical response is to:
Answer: Refuse to sign until they have conducted a thorough review
Signing regulatory documents attests to their accuracy and completeness; signing without review constitutes a false attestation.