SOCRA Protocol Deviations and Violations 1

Question 1

Which of the following BEST defines a protocol deviation in a clinical trial?

Accepted Answer

An unplanned departure from the procedures described in the approved protocol

Answer

A protocol deviation is an unplanned, unintentional departure from the approved protocol procedures that occurs during the conduct of a study.

Question 2

A subject enrolled in a clinical trial misses a required blood draw by 5 days due to a personal emergency. How should the Clinical Research Coordinator (CRC) handle this?

Accepted Answer

Document the missed visit as a protocol deviation and notify the PI and sponsor

Answer

Missed assessments outside the protocol-specified window must be documented as protocol deviations and reported per the sponsor's and IRB's procedures.

Question 3

Under ICH E6(R2) Good Clinical Practice, which party bears primary responsibility for ensuring protocol compliance at the investigative site?

Accepted Answer

The Principal Investigator (PI)

Answer

ICH E6(R2) Section 4.1 states the investigator is responsible for conducting the trial in compliance with the protocol agreed to by the sponsor and approved by the IRB.

Question 4

Which of the following protocol deviations would MOST likely be classified as a major (significant) deviation requiring prompt IRB reporting?

Accepted Answer

An ineligible subject was enrolled because inclusion criteria were not properly verified

Answer

Enrolling an ineligible subject directly violates inclusion/exclusion criteria, potentially affecting subject safety and data integrity, making it a major deviation requiring prompt IRB notification.

Question 5

What is the PRIMARY distinction between a protocol deviation and a protocol violation?

Accepted Answer

A violation is a deviation that significantly affects subject safety or data integrity

Answer

While usage varies by organization, a protocol violation is generally considered a deviation that significantly affects subject rights, safety, or the integrity of study data.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Protocol Deviations and Violations 1