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CATO Associate Clinical Trial Operations Flashcards

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

Read the first 6 CATO Associate Clinical Trial Operations flashcards as text
  1. What is the primary objective of Phase I in clinical trials?

    Answer: Evaluate safety and dosage in healthy volunteers

    Phase I focuses on evaluating the safety, dosage range, and side effects of a new drug in a small group of participants.

  2. What is an essential document for participant protection in a clinical trial?

    Answer: Informed consent form

    The informed consent form ensures participants understand the risks and procedures before joining the trial.

  3. Which role is responsible for monitoring site compliance and data integrity?

    Answer: Clinical Research Associate (CRA)

    Clinical Research Associates (CRAs) ensure that clinical sites follow protocols and accurately report trial data.

  4. Why are inclusion and exclusion criteria used in clinical trials?

    Answer: To ensure consistent and safe study population

    These criteria help define the study population, reduce variability, and enhance participant safety.

  5. What is the function of a Data Safety Monitoring Board (DSMB)?

    Answer: Review data for safety concerns

    A DSMB independently reviews clinical trial data to ensure participant safety and trial integrity.

  6. What must occur before a clinical trial can begin?

    Answer: IRB approval

    Approval from an Institutional Review Board (IRB) is required to ensure ethical standards are met.