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Data Management & Analysis Flashcards

7 cards from real CPI 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 Management & Analysis flashcards as text

  1. A researcher discovers mid-study that a database field was miscoded for 15% of participants. What is the most appropriate first step?

    Answer: Document the error and assess its impact on study outcomes

    Documenting the error and assessing its impact is the first step before deciding on corrective actions.

  2. Which statistical method is most appropriate for analyzing survival time data in a clinical trial?

    Answer: Kaplan-Meier analysis

    Kaplan-Meier analysis is specifically designed to estimate survival functions from time-to-event data.

  3. Under FDA 21 CFR Part 11, which of the following is required for electronic records to be considered trustworthy?

    Answer: System must include audit trails that are computer-generated and tamper-evident

    21 CFR Part 11 requires computer-generated, time-stamped audit trails that cannot be modified without detection.

  4. A dataset contains multiple measurements of the same variable collected at different time points. Which analysis approach best handles the within-subject correlation?

    Answer: Mixed-effects models or repeated measures ANOVA

    Mixed-effects models and repeated measures ANOVA account for the correlation structure of longitudinal within-subject data.

  5. What does 'data provenance' refer to in research data management?

    Answer: The chronological documentation of data origins and transformations

    Data provenance tracks where data came from and every transformation it has undergone, ensuring reproducibility.

  6. Which approach to missing data is generally considered superior to complete-case analysis?

    Answer: Multiple imputation

    Multiple imputation preserves statistical power and produces unbiased estimates under missing-at-random assumptions.

  7. In a data safety monitoring board (DSMB) review, unblinded interim data is shared. What is the primary data management concern?

    Answer: Maintaining confidentiality to prevent unblinding of the ongoing trial

    DSMB members receive unblinded data, so strict confidentiality procedures must prevent premature unblinding of investigators.