Practice Test Geeks(CCA) CATO Certified Associate Practice Test
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CATO Associate Clinical Trial Operations Flashcards

7 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 7 CATO Associate Clinical Trial Operations flashcards as text

  1. Which document outlines the rights, safety, and well-being protections for clinical trial participants and must be reviewed by an IRB/IEC before a trial begins?

    Answer: Informed Consent Form

    The Informed Consent Form (ICF) must be reviewed and approved by the IRB/IEC prior to trial initiation to protect participant rights.

  2. In a randomized controlled trial, what is the primary purpose of blinding?

    Answer: To eliminate bias in treatment assignment and outcome assessment

    Blinding prevents knowledge of treatment assignment from influencing outcome assessment, reducing bias in the trial results.

  3. What term describes the process by which a sponsor transfers some or all trial-related duties to a Contract Research Organization (CRO)?

    Answer: Outsourcing

    Outsourcing refers to the formal transfer of trial-related tasks and functions from a sponsor to a CRO.

  4. Which phase of clinical development is primarily designed to establish the maximum tolerated dose (MTD) of a new drug?

    Answer: Phase I

    Phase I trials are first-in-human studies focused on safety, tolerability, and identifying the maximum tolerated dose.

  5. A protocol deviation that significantly affects the rights, safety, or well-being of participants is classified as a:

    Answer: Serious breach

    A serious breach is a deviation that significantly impacts participant safety, rights, or data integrity and requires regulatory notification.

  6. Which ICH E6(R2) principle requires that the investigator be qualified by training and experience to conduct the clinical trial?

    Answer: Principle 4

    ICH E6(R2) Principle 4 states that each individual involved in conducting a trial should be qualified by education, training, and experience.

  7. When a clinical trial site closes, which action regarding essential documents is required?

    Answer: Documents must be archived for the required retention period per regulations

    Essential documents must be retained for the regulatory-required period (commonly 15 years post-marketing or 2 years post-IND closure) to support regulatory inspections.