Practice Test Geeks(CCDM) Certified Clinical Data Manager Practice Test
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Statistical Analysis 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 Statistical Analysis flashcards as text

  1. A non-inferiority trial is designed to show that a new treatment is:

    Answer: Not worse than an active comparator by more than a pre-specified margin

    Non-inferiority trials aim to demonstrate that the new treatment is not worse than the comparator by more than a clinically acceptable margin (delta).

  2. When analyzing ordered categorical data (e.g., none/mild/moderate/severe), which test is most appropriate?

    Answer: Wilcoxon rank-sum test (Mann-Whitney U)

    The Wilcoxon rank-sum test is suitable for ordinal data as it uses ranks rather than assuming a normal distribution of continuous values.

  3. In a randomized controlled trial, what is the primary role of a Data Safety Monitoring Board (DSMB) regarding interim analyses?

    Answer: To review accumulating data and recommend stopping or continuing the trial

    The DSMB independently reviews interim safety and efficacy data and may recommend early stopping for benefit, harm, or futility.

  4. Which approach controls the overall Type I error rate when testing a primary and key secondary endpoint in a hierarchical manner?

    Answer: Fixed-sequence testing, proceeding to the next endpoint only if the prior is significant

    Fixed-sequence (hierarchical) testing preserves the family-wise error rate by requiring each prior test to be significant before proceeding.

  5. In logistic regression for a binary clinical endpoint, the exponentiated regression coefficient (e^β) represents:

    Answer: The odds ratio for the outcome per unit increase in the predictor

    Exponentiating the logistic regression coefficient yields the odds ratio, which quantifies the association between the predictor and the binary outcome.

  6. What is the key assumption of a mixed-effects model for repeated measures (MMRM) regarding missing data?

    Answer: Data are Missing at Random (MAR) — missingness depends only on observed data

    MMRM assumes data are MAR, meaning that the probability of missingness may depend on previously observed data but not on unobserved outcomes.

  7. In a Phase III clinical trial, what does 'blinding' primarily protect against?

    Answer: Bias in outcome assessment and patient behavior due to knowledge of treatment assignment

    Blinding prevents knowledge of treatment assignment from influencing outcome assessment, patient behavior, or clinical decision-making.