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
A sponsor requests an unplanned subgroup analysis after observing the overall trial result. What is the primary concern with this request?
Answer: Unplanned analyses increase the risk of false-positive findings due to multiple comparisons
Post-hoc subgroup analyses inflate Type I error risk because multiple comparisons increase the chance of finding a statistically significant result by chance.
What is the difference between 'efficacy' and 'effectiveness' in clinical research?
Answer: Efficacy is measured under controlled trial conditions; effectiveness reflects real-world performance
Efficacy refers to how well a treatment works under ideal, controlled conditions, while effectiveness reflects performance in routine clinical practice.
In clinical trials, 'stratified randomization' is used primarily to:
Answer: Ensure balance of key prognostic factors across treatment groups
Stratified randomization ensures that important prognostic variables (e.g., disease severity, age) are evenly distributed between treatment arms.
Which of the following is the BEST example of a validated patient-reported outcome (PRO) instrument?
Answer: A disease-specific quality-of-life questionnaire developed and validated per FDA PRO guidance
A PRO instrument must be developed and validated according to FDA PRO guidance to demonstrate it measures what it intends to measure reliably.
During source data verification (SDV), a monitor finds that a lab value in the CRF differs from the lab report by 2 units. What should happen?
Answer: The site should be notified via a query and the discrepancy resolved with a traceable correction
SDV discrepancies must be resolved through a formal query process ensuring corrections are documented, traceable, and consistent with source data.
What is the purpose of a 'washout period' in a crossover trial?
Answer: To eliminate residual effects of the first treatment before administering the second
A washout period ensures residual pharmacological effects from the first treatment do not carry over and confound results in the second period.
Which of the following best describes 'data lock' (database lock) in a clinical trial?
Answer: Finalizing and freezing the database after all queries are resolved so no further changes can be made before analysis
Database lock is the point at which all queries are resolved and the database is frozen, ensuring the analysis dataset cannot be altered.