Practice Test Geeks(CCA) CATO Certified Associate Practice Test
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CATO Associate Regulatory Compliance 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.

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  1. Which agency is responsible for regulating clinical trials in the United States?

    Answer: FDA

    The FDA oversees the conduct of clinical trials to ensure the safety and efficacy of drugs and devices.

  2. What is the purpose of Good Clinical Practice (GCP) guidelines?

    Answer: To protect participant rights and data integrity

    GCP ensures ethical and scientific quality standards in the design, conduct, and reporting of clinical trials.

  3. Which form must be submitted to the FDA before beginning a clinical trial?

    Answer: IND application

    The Investigational New Drug (IND) application must be submitted and approved before human testing can begin.

  4. What role does an Institutional Review Board (IRB) play in clinical research?

    Answer: It protects participants' rights and safety

    The IRB reviews and approves study protocols to ensure ethical treatment of participants.

  5. How often must IRB continuing reviews be conducted for ongoing studies?

    Answer: Annually

    IRB continuing reviews are typically required annually to maintain ethical oversight of ongoing trials.

  6. What is a protocol deviation?

    Answer: A change from the approved study plan

    A protocol deviation is any change or departure from the approved study plan, which must be documented and assessed for impact.