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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 principal investigator receives a data request from a co-investigator at another institution. What must be in place before sharing identifiable research data?

    Answer: A signed Data Use Agreement (DUA) approved by both institutions

    A Data Use Agreement defines the terms under which identifiable data may be shared and is required by HIPAA and most institutional policies.

  2. Which type of validity refers to the extent to which a measurement instrument actually measures what it claims to measure?

    Answer: Construct validity

    Construct validity assesses whether a measurement tool accurately captures the theoretical construct it is intended to measure.

  3. A researcher uses a p-value threshold of 0.05 across 20 hypothesis tests simultaneously. What statistical issue arises?

    Answer: Inflated family-wise type I error rate

    Conducting multiple tests without adjustment inflates the probability of finding at least one false positive (type I error).

  4. According to GCP guidelines, how long must investigators retain essential clinical trial documents after study completion?

    Answer: At least 2 years after the last marketing approval or after a formal notification that no further marketing is pursued

    ICH E6 GCP requires retention for at least 2 years after the last marketing approval or study termination notification.

  5. What is the purpose of a range check in clinical data validation?

    Answer: To flag values that fall outside predefined clinically plausible limits

    Range checks identify data entry errors by flagging values outside expected physiological or logical boundaries.

  6. In epidemiological research, what does 'attributable risk' measure?

    Answer: The absolute difference in disease rates between exposed and unexposed groups

    Attributable risk (risk difference) quantifies the excess risk in the exposed group compared to the unexposed group.

  7. A researcher wants to assess inter-rater reliability for a continuous measurement. Which statistic is most appropriate?

    Answer: Intraclass correlation coefficient (ICC)

    The ICC measures the degree of agreement and consistency between raters for continuous data, accounting for systematic biases.