SOCRA Protocol Deviations and Violations 3

Question 1

ICH E6(R2) Section 5.20.1 states that a sponsor's Quality Management System should include risk-based approaches. How does this apply to protocol deviation management?

Accepted Answer

Sponsors should focus oversight resources on deviations that pose the greatest risk to subject safety and data reliability

Answer

ICH E6(R2) emphasizes risk-based quality management, which means sponsors and sites should prioritize resources to address deviations with the greatest potential impact on subject safety and data integrity.

Question 2

A subject withdraws consent during a study visit but the CRC continues collecting scheduled data before the withdrawal is formally processed. This situation BEST represents:

Accepted Answer

A serious protocol violation that also constitutes a breach of ethical principles

Answer

Collecting data from a subject after withdrawal of consent violates both the protocol and the fundamental ethical principle of respect for persons, constituting a serious protocol violation.

Question 3

Which of the following is a key indicator that a site has a systemic protocol compliance problem rather than isolated deviations?

Accepted Answer

Recurring deviations of the same type across multiple subjects and multiple monitoring visits

Answer

Repeated deviations of the same type across multiple subjects and visits indicate a systemic process failure requiring root cause analysis and systemic corrective action.

Question 4

A subject was randomized into a study but was later found to have been ineligible due to a prohibited concomitant medication. The data monitor committee (DMC) is evaluating the study. This deviation should PRIMARILY be reported to:

Accepted Answer

The IRB, the sponsor, and documented in the regulatory binder

Answer

An enrollment eligibility deviation must be reported to the IRB as a protocol deviation and to the sponsor, and fully documented in the site's regulatory files.

Question 5

Under 21 CFR 312.66, an investigator must promptly report to the IRB any protocol deviations made to:

Accepted Answer

Eliminate apparent immediate hazards to human subjects

Answer

21 CFR 312.66 specifically requires investigators to report to the IRB any deviations from the approved protocol made to eliminate apparent immediate hazards to the human subjects.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Protocol Deviations and Violations 3