Practice Test Geeks(CCA) CATO Certified Associate Practice Test
← All CCA Flashcard Decks

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 type of audit examines whether a vendor or CRO is performing delegated trial tasks in compliance with GCP and contractual requirements?

    Answer: Vendor/CRO audit

    A vendor or CRO audit evaluates whether outsourced functions are being performed per GCP standards and the terms of the contract.

  2. What is the purpose of a 'washout period' in a crossover clinical trial design?

    Answer: To eliminate the effects of a previous treatment before starting the next one

    A washout period ensures that any pharmacological effects of a prior treatment have cleared before the next treatment is administered.

  3. Under ICH E6(R2), who bears ultimate responsibility for the quality and integrity of the trial data?

    Answer: The sponsor

    ICH E6(R2) places ultimate responsibility for trial quality and data integrity on the sponsor, even when tasks are delegated.

  4. A clinical trial protocol includes an 'efficacy estimand.' What does this concept define?

    Answer: The precise treatment effect to be estimated, accounting for intercurrent events

    An estimand precisely defines the treatment effect of interest, including how intercurrent events (like treatment discontinuation) are handled, per ICH E9(R1).

  5. Which action is required when the principal investigator at a clinical trial site changes during an ongoing study?

    Answer: The sponsor and IRB/IEC must be notified, and the new PI must be qualified and approved

    A change in PI requires notification to the sponsor and IRB/IEC, and the new investigator must meet qualifications before assuming responsibilities.

  6. What is 'source data verification' (SDV) in the context of clinical trial monitoring?

    Answer: Comparing data in case report forms against original source documents to check accuracy

    SDV is the process of comparing CRF data against source documents (e.g., medical records, lab reports) to verify accuracy and completeness.

  7. In clinical trial operations, what does a 'protocol synopsis' typically contain?

    Answer: A condensed summary of the key elements of the full protocol

    A protocol synopsis is a brief summary of the trial's objectives, design, population, endpoints, and key procedures, derived from the full protocol.