Practice Test Geeks(CPI) Certified Physician Investigator Practice Test
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Data Collection & Analysis Techniques 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 Collection & Analysis Techniques flashcards as text

  1. A clinical trial uses an electronic data capture (EDC) system. Which feature of EDC best supports data integrity?

    Answer: Built-in edit checks and audit trails that record all changes

    EDC systems with edit checks and comprehensive audit trails ensure data accuracy, completeness, and traceability per ALCOA+ principles.

  2. In hypothesis testing for a clinical trial, a p-value of 0.03 with an alpha level set at 0.05 means:

    Answer: The result is statistically significant and the null hypothesis is rejected

    A p-value below the pre-specified alpha level (0.03 < 0.05) indicates statistical significance, leading to rejection of the null hypothesis.

  3. Which type of data collection instrument is MOST susceptible to recall bias?

    Answer: Retrospective questionnaire asking about symptoms over the past year

    Retrospective questionnaires rely on participants' memory over extended periods, making them particularly vulnerable to recall bias.

  4. The ALCOA-C principles for clinical data integrity stand for:

    Answer: Attributable, Legible, Contemporaneous, Original, Accurate — Complete

    ALCOA-C stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete — the FDA's foundational principles for data integrity.

  5. A Data Safety Monitoring Board (DSMB) reviews unblinded interim data in a trial. What is their primary responsibility?

    Answer: Monitoring for unexpected safety signals and recommending trial continuation, modification, or stopping

    The DSMB independently reviews unblinded data to protect participants by recommending trial continuation, modification, or early termination based on safety and efficacy.

  6. Which scale of measurement allows for meaningful ratios between values (e.g., 20 mg is twice 10 mg)?

    Answer: Ratio

    Ratio scales have a true zero point and equal intervals, allowing meaningful ratio comparisons between values.

  7. In a per-protocol (PP) analysis, which participants are typically excluded?

    Answer: Participants who did not meet eligibility criteria or had major protocol deviations

    Per-protocol analysis includes only participants who adhered to the protocol without major deviations, providing an efficacy estimate under ideal conditions.