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
A researcher uses convenience sampling to recruit 200 college students for a stress study. Which limitation does this introduce?
Answer: Limited generalizability to broader populations
Convenience samples may not represent the target population, restricting the external validity of findings.
What is the primary advantage of using an electronic data capture (EDC) system over paper-based case report forms?
Answer: Real-time validation, query generation, and reduced transcription errors
EDC systems enforce validation rules at entry, automatically generate data queries, and remove the paper-to-database transcription step.
In a meta-analysis, what does a funnel plot asymmetry most likely suggest?
Answer: Publication bias, with smaller negative studies underrepresented
Funnel plot asymmetry suggests that small studies with unfavorable results may not have been published, indicating publication bias.
Which analysis principle requires that all randomized participants be included in the primary analysis in the group to which they were assigned, regardless of protocol adherence?
Answer: Intention-to-treat (ITT) analysis
ITT analysis preserves the randomization balance and prevents bias from selective exclusion of non-compliant participants.
A study uses a Likert scale to measure patient satisfaction. What level of measurement does this represent?
Answer: Ordinal
Likert scales produce ordinal data because responses are ranked but intervals between categories are not assumed to be equal.
A sponsor requests that a site re-enter all CRF data because the original EDC vendor changed. What is the key data integrity requirement?
Answer: Ensure the transferred data matches source documents and original entries exactly
Data migration must be validated to confirm 100% accuracy against source documents and original entries to maintain regulatory compliance.
What is a confounding variable in the context of research data analysis?
Answer: A variable associated with both the exposure and outcome that distorts the true relationship
A confounder is independently associated with both the exposure and the outcome, potentially creating a spurious or masked association.