Practice Test Geeks(CPI) Certified Physician Investigator Practice Test
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Clinical Research & Study Design 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 Clinical Research & Study Design flashcards as text

  1. Which of the following best defines 'protocol deviation' versus 'protocol violation'?

    Answer: A deviation is any departure from the protocol; a violation is a deviation that could affect subject safety or data integrity

    Protocol deviations encompass all departures from the protocol, while violations specifically threaten subject safety, rights, or data reliability.

  2. In an adaptive trial design, a pre-planned interim analysis may allow:

    Answer: Sample size re-estimation or arm discontinuation based on accumulating data

    Pre-planned adaptations such as sample-size re-estimation or dropping ineffective arms are key features of adaptive designs, maintaining statistical validity.

  3. Which statistical concept describes the probability of detecting a true treatment effect when one exists?

    Answer: Statistical power (1 – beta)

    Statistical power is 1 minus the Type II error rate (beta) and represents the probability of correctly rejecting a false null hypothesis.

  4. A Phase I dose-escalation study in oncology most commonly uses the 3+3 design to determine the:

    Answer: Maximum tolerated dose (MTD)

    The 3+3 design escalates doses in cohorts of three patients and defines the MTD based on dose-limiting toxicity occurrence.

  5. Which of the following is an example of information bias in clinical research?

    Answer: Systematic over-reporting of symptoms in one exposure group

    Information bias arises when data are collected or recorded differently across groups, such as when exposed participants are questioned more thoroughly about symptoms.

  6. The number needed to treat (NNT) is calculated as:

    Answer: 1 divided by the absolute risk reduction

    NNT = 1 / ARR (absolute risk reduction); it tells clinicians how many patients must be treated to prevent one additional adverse outcome.

  7. When a study sponsor monitors a clinical trial site, which document is the primary source for verifying data entered into the CRF?

    Answer: Source document (medical record, lab report, etc.)

    Source data verification (SDV) involves comparing CRF entries against original source documents to confirm accuracy and completeness.