Practice Test Geeks(CCA) CATO Certified Associate Practice Test
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CATO Associate Study Close-Out & Archiving 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. What is the primary purpose of a site close-out visit (COV) in a clinical trial?

    Answer: To ensure all study activities are complete, IP is reconciled and returned/destroyed, data queries resolved, and essential documents are in order for archiving

    The COV confirms that all trial activities have been completed, IP accounted for, data finalized, and documents are ready for archiving per sponsor and regulatory requirements.

  2. How long must clinical trial records typically be retained at the investigative site under FDA regulations?

    Answer: 2 years after the latest marketing application is approved, or 2 years after the IND is withdrawn (per 21 CFR 312.62)

    Under 21 CFR 312.62, investigators must retain records for 2 years following the date a marketing application is approved, or 2 years after the IND is discontinued.

  3. What is 'database lock' in the context of clinical trial close-out?

    Answer: The formal process of finalizing the clinical database after all data cleaning is complete, preventing further changes

    Database lock is the point at which all data cleaning is complete, the database is reviewed and approved, and it is formally locked against further changes prior to analysis.

  4. What activities must be completed BEFORE a site close-out visit can occur?

    Answer: All subject visits completed or early terminated, all data queries resolved, IP reconciled, and all SAEs resolved or with final status

    Before COV, all subject participation must be completed, data queries resolved, IP fully reconciled, and SAEs documented to their final status.

  5. What is the purpose of the 'end of trial notification' submitted to regulatory authorities?

    Answer: To officially inform regulatory authorities that the clinical trial has ended in compliance with regulatory requirements

    An end of trial notification formally informs regulatory authorities that the trial has concluded, triggering applicable post-trial reporting and archiving obligations.

  6. What is 'data query resolution' and why is it critical before database lock?

    Answer: The process of identifying, issuing, and resolving inconsistencies or missing data in the CRF before the database is finalized

    Data query resolution ensures all CRF data is accurate, consistent, and complete before database lock, protecting the integrity of the final analysis dataset.