CPI Data Collection & Analysis Techniques 2

Question 1

In a clinical trial, what is the primary purpose of using a double-blind design when collecting outcome data?

Accepted Answer

To eliminate bias from both participant and assessor expectations

Answer

Double-blind design prevents both participants and outcome assessors from knowing treatment assignment, minimizing performance and detection bias.

Question 2

Which statistical method is most appropriate for analyzing time-to-event data in a clinical trial comparing two treatment arms?

Accepted Answer

Kaplan-Meier survival analysis with log-rank test

Answer

Kaplan-Meier survival analysis with the log-rank test is the standard approach for comparing time-to-event outcomes between treatment groups.

Question 3

A physician investigator notices that laboratory values collected at one site are consistently 10% higher than other sites. This is an example of:

Accepted Answer

Systematic bias

Answer

Consistent directional differences across a site indicate systematic bias, often due to equipment calibration or procedural differences.

Question 4

What does the term 'imputation' refer to in clinical trial data analysis?

Accepted Answer

Assigning values to missing data using statistical methods

Answer

Imputation is the process of substituting estimated values for missing data to maintain dataset completeness and reduce bias.

Question 5

Under ICH E6(R2) GCP guidelines, how long must essential trial documents generally be retained after completion of the trial?

Accepted Answer

At least 2 years after the last marketing approval or 2 years after formal discontinuation

Answer

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.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Data Collection & Analysis Techniques 2