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Professional Standards and Ethics Flashcards

7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Professional Standards and Ethics flashcards as text

  1. What is the correct way to correct an error on a paper source document under GCP?

    Answer: Draw a single line through the error, write the correction, and initial and date it

    Corrections must keep the original entry legible and be initialed and dated to maintain an audit trail.

  2. A participant cannot read but wishes to enroll. Under FDA and GCP guidance, what is typically required during consent?

    Answer: An impartial witness present for the entire consent discussion who also signs the form

    An impartial witness attests that the information was accurately explained and that consent was freely given.

  3. An investigator deviates from the protocol to eliminate an immediate hazard to a participant without prior IRB approval. How is this handled?

    Answer: It is permitted, but must be reported to the IRB promptly afterward

    Changes to eliminate apparent immediate hazards may be implemented before IRB approval but must be reported promptly.

  4. Which best describes the role of a Data and Safety Monitoring Board (DSMB)?

    Answer: Independently reviewing accumulating data to protect participant safety and study integrity

    A DSMB is an independent group that reviews interim data and can recommend continuing, modifying, or stopping a trial.

  5. A research assistant recognizes a participant at a social event. What should they do to protect confidentiality?

    Answer: Not reveal the person's participation and let the participant initiate any contact

    Disclosing someone's research participation, even socially, can breach confidentiality.

  6. Who may be listed as an author on a research publication under ICMJE criteria?

    Answer: Only those who made substantial contributions, drafted or revised the work, approved the final version, and agree to be accountable

    ICMJE requires all four criteria for authorship; other contributors should be acknowledged instead.

  7. Listing a senior department chair as an author despite no contribution to the work is an example of what?

    Answer: Gift (honorary) authorship

    Gift or honorary authorship credits someone who did not meet authorship criteria.