CPI Data Collection & Analysis Techniques 3

Question 1

A clinical trial uses an electronic data capture (EDC) system. Which feature of EDC best supports data integrity?

Accepted Answer

Built-in edit checks and audit trails that record all changes

Answer

EDC systems with edit checks and comprehensive audit trails ensure data accuracy, completeness, and traceability per ALCOA+ principles.

Question 2

In hypothesis testing for a clinical trial, a p-value of 0.03 with an alpha level set at 0.05 means:

Accepted Answer

The result is statistically significant and the null hypothesis is rejected

Answer

A p-value below the pre-specified alpha level (0.03 < 0.05) indicates statistical significance, leading to rejection of the null hypothesis.

Question 3

Which type of data collection instrument is MOST susceptible to recall bias?

Accepted Answer

Retrospective questionnaire asking about symptoms over the past year

Answer

Retrospective questionnaires rely on participants' memory over extended periods, making them particularly vulnerable to recall bias.

Question 4

The ALCOA-C principles for clinical data integrity stand for:

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate — Complete

Answer

ALCOA-C stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete — the FDA's foundational principles for data integrity.

Question 5

A Data Safety Monitoring Board (DSMB) reviews unblinded interim data in a trial. What is their primary responsibility?

Accepted Answer

Monitoring for unexpected safety signals and recommending trial continuation, modification, or stopping

Answer

The DSMB independently reviews unblinded data to protect participants by recommending trial continuation, modification, or early termination based on safety and efficacy.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Data Collection & Analysis Techniques 3