Practice Test Geeks(CCDM) Certified Clinical Data Manager Practice Test
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Data Validation Flashcards

7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Data Validation flashcards as text

  1. Which type of validation check ensures that a date field contains a value that is chronologically possible within the study context?

    Answer: Logical check

    A logical check verifies that dates are chronologically sensible, such as ensuring that the informed consent date precedes the first visit date.

  2. In clinical data management, what is a 'discrepancy' most accurately defined as?

    Answer: A data value that does not meet predefined validation criteria

    A discrepancy is a data value that fails to meet predefined validation criteria, triggering a query to the site for clarification or correction.

  3. What is the primary purpose of a User Acceptance Testing (UAT) phase in clinical database validation?

    Answer: To confirm the database meets sponsor and regulatory requirements before go-live

    UAT confirms that the clinical database system functions as specified and meets all sponsor and regulatory requirements before it is released for live data entry.

  4. Which edit check type would flag a record where a subject is noted as pregnant but the recorded gender is male?

    Answer: Cross-field consistency check

    A cross-field consistency check compares values across multiple fields to detect biologically or logically impossible combinations.

  5. According to ICH E6(R2), what should be the basis for the scope and nature of data validation procedures?

    Answer: A risk-based approach focusing on critical data and processes

    ICH E6(R2) mandates a risk-based approach to data management, meaning validation efforts should be proportionate to the risk and importance of the data.

  6. What does 'data lock' signify in the context of clinical trial data validation?

    Answer: The formal closure of the database after all validation activities are complete

    Database lock is the formal process of closing the clinical database to further changes after all data cleaning and validation activities have been completed.

  7. A validation check that ensures a subject's age at screening is between 18 and 75 years is an example of which type?

    Answer: Range check

    A range check verifies that a numeric value falls within a predefined acceptable minimum and maximum boundary, such as an age eligibility window.