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
In a clinical trial, what is the primary purpose of using a double-blind design when collecting outcome data?
Answer: To eliminate bias from both participant and assessor expectations
Double-blind design prevents both participants and outcome assessors from knowing treatment assignment, minimizing performance and detection bias.
Which statistical method is most appropriate for analyzing time-to-event data in a clinical trial comparing two treatment arms?
Answer: Kaplan-Meier survival analysis with log-rank test
Kaplan-Meier survival analysis with the log-rank test is the standard approach for comparing time-to-event outcomes between treatment groups.
A physician investigator notices that laboratory values collected at one site are consistently 10% higher than other sites. This is an example of:
Answer: Systematic bias
Consistent directional differences across a site indicate systematic bias, often due to equipment calibration or procedural differences.
What does the term 'imputation' refer to in clinical trial data analysis?
Answer: Assigning values to missing data using statistical methods
Imputation is the process of substituting estimated values for missing data to maintain dataset completeness and reduce bias.
Under ICH E6(R2) GCP guidelines, how long must essential trial documents generally be retained after completion of the trial?
Answer: At least 2 years after the last marketing approval or 2 years after formal discontinuation
ICH E6(R2) requires retention of essential documents for at least 2 years after the last approval or 2 years after formal discontinuation, though local regulations may require longer.
Which of the following best describes an 'interim analysis' in a clinical trial?
Answer: A pre-specified analysis of accumulating data before trial completion
An interim analysis is a pre-specified examination of accumulating data during a trial, often used for safety monitoring or adaptive design decisions.
When a CRF field is left blank and no data were collected, what is the most appropriate action for the investigator?
Answer: Document the reason for missing data according to protocol and sponsor instructions
Missing data must be documented with the reason according to protocol requirements; fabricating or estimating values without a pre-specified method is a GCP violation.