CTA Protocol Development & Review 2

Question 1

Which section of a clinical trial protocol defines the statistical methods for analyzing primary and secondary endpoints?

Accepted Answer

Statistical Analysis Plan

Answer

The Statistical Analysis Plan (SAP) section of the protocol defines the methods for analyzing primary and secondary endpoints.

Question 2

When a protocol amendment significantly changes the risk-benefit profile of a study, what is the FIRST required action?

Accepted Answer

Submit the amendment to the IRB/IEC for review and approval

Answer

Significant protocol amendments that affect risk-benefit must be submitted to the IRB/IEC for review and approval before implementation.

Question 3

What is the purpose of a protocol deviation log in clinical trial management?

Accepted Answer

To track and report all instances where the protocol was not followed

Answer

A protocol deviation log systematically tracks all instances where the study was not conducted per the approved protocol.

Question 4

Under ICH E6(R2), which element is NOT typically required in the protocol background and rationale section?

Accepted Answer

Detailed manufacturing process for the investigational product

Answer

The detailed manufacturing process belongs in the Investigator's Brochure, not in the protocol's background and rationale section.

Question 5

A protocol specifies a 7-day visit window for a study assessment. A subject's scheduled Day 30 visit occurs on Day 38. How should this be classified?

Accepted Answer

Protocol deviation

Answer

Missing the allowed visit window constitutes a protocol deviation that must be documented.

(CTA) Clinical Trial Associate Certification Practice Test