CCRA Certified Clinical Research Study 4

Question 1

During site close-out, the CRA confirms that all essential documents are filed, IP is reconciled, and staff is debriefed. Which document officially marks the end of a site's participation in a trial?

Accepted Answer

Site Close-Out Letter

Answer

The Site Close-Out Letter is the formal communication from the sponsor to the investigator confirming the site's participation in the study has ended.

Question 2

Which ICH guideline specifically addresses the statistical principles for the design and analysis of confirmatory clinical trials?

Accepted Answer

ICH E9

Answer

ICH E9 (Statistical Principles for Clinical Trials) provides guidance on statistical methodology for confirmatory efficacy and safety trials.

Question 3

A study subject becomes pregnant during a clinical trial of a teratogenic investigational compound. After being taken off study drug, what additional obligation typically applies?

Accepted Answer

The pregnancy must be reported as an SAE and followed to outcome

Answer

Pregnancies in trials of potentially teratogenic drugs are typically reportable SAEs, and pregnancy outcomes (including neonatal outcomes) must be tracked and reported.

Question 4

Which of the following best describes 'audit trail' as it relates to electronic data capture (EDC) systems under 21 CFR Part 11?

Accepted Answer

A secure, computer-generated record that captures who made changes, what was changed, and when

Answer

21 CFR Part 11 requires EDC systems to maintain a secure, time-stamped audit trail of all data entries and changes attributable to the individual who made them.

Question 5

In a double-blind, randomized clinical trial, who is permitted to access the randomization codes in an emergency?

Accepted Answer

The treating physician when unblinding is medically necessary for a subject's safety

Answer

Emergency unblinding is permitted when the treating physician determines that knowledge of treatment assignment is necessary to provide appropriate medical care to the subject.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Certified Clinical Research Study 4