Practice Test Geeks(CPI) Certified Physician Investigator Practice Test
← All CPI Flashcard Decks

Ethics & Professional 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 Ethics & Professional Standards flashcards as text

  1. When a research participant withdraws consent mid-trial, what is the investigator's primary obligation?

    Answer: Stop participation immediately and retain only already-collected data per protocol

    Withdrawal must be honored immediately, but data already lawfully collected may be retained as specified in the IRB-approved protocol.

  2. Which ethical principle primarily guides the requirement that research risks must be minimized and justified by anticipated benefits?

    Answer: Beneficence

    Beneficence obligates investigators to maximize benefits and minimize harms, requiring a favorable risk-benefit ratio.

  3. An investigator discovers a serious, unexpected adverse event. Under FDA regulations, the sponsor must report it to the FDA within:

    Answer: 7 calendar days if fatal or life-threatening; 15 calendar days for others

    FDA 21 CFR 312.32 requires 7-calendar-day reporting for fatal/life-threatening unexpected SAEs and 15-calendar-day reporting for other unexpected serious adverse events.

  4. Which document outlines the globally accepted ethical principles for conducting research involving human subjects that emerged from the Nuremberg trials?

    Answer: Nuremberg Code

    The Nuremberg Code (1947) established foundational ethical principles for human experimentation, including voluntary consent, after Nazi war crimes.

  5. A CPI learns that a colleague has fabricated patient data in a clinical trial. What is the most appropriate immediate action?

    Answer: Report the misconduct to the IRB, sponsor, and relevant institutional authorities

    Research misconduct must be reported to protect participants and the integrity of science; self-correction by the offending party is insufficient.

  6. Under ICH E6(R2) GCP, the investigator's primary responsibility regarding protocol deviations is to:

    Answer: Document all deviations and notify the IRB/ethics committee and sponsor as required

    ICH E6(R2) requires investigators to document protocol deviations promptly and report them per sponsor and IRB requirements.

  7. Which scenario best illustrates a conflict of interest for a physician investigator?

    Answer: Being the principal investigator for a drug manufactured by a company in which the PI holds significant equity

    Financial interests in a sponsor company can bias study conduct or reporting, constituting a conflict of interest that must be disclosed.