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CATO Associate Ethics & Good Clinical Practice (GCP) Flashcards

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

Read the first 6 CATO Associate Ethics & Good Clinical Practice (GCP) flashcards as text
  1. What is the primary focus of Good Clinical Practice (GCP)?

    Answer: Protect participants and ensure data quality

    GCP provides a framework to protect the rights, safety, and well-being of clinical trial participants and ensures credible data.

  2. Which of the following is a core ethical principle in clinical research?

    Answer: Respect for persons

    Respect for persons includes informed consent, acknowledging autonomy, and protecting those with diminished autonomy.

  3. Why must informed consent be obtained before trial participation?

    Answer: To ensure voluntary, informed participation

    Informed consent ensures that participants voluntarily agree to join the study with full knowledge of risks and benefits.

  4. What does the Declaration of Helsinki provide?

    Answer: Ethical principles for medical research

    This document outlines ethical principles for medical research involving human subjects, developed by the World Medical Association.

  5. What role does the IRB play in ethical oversight?

    Answer: Reviews studies for ethical compliance

    The IRB reviews research proposals to ensure the protection of participants’ rights and welfare.

  6. Which document affirms compliance with GCP and ethical conduct?

    Answer: Form 1572

    The investigator’s signed Form 1572 confirms adherence to GCP guidelines and regulatory requirements.