Protocol Deviations and Violations Flashcards

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

Answer: An unplanned departure from the procedures described in the approved protocol

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

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?

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

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

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

Answer: The Principal Investigator (PI)

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.

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

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

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.

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

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

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.

According to FDA regulations at 21 CFR 312.62, how long must an investigator retain records of protocol deviations for drugs studied under an IND?

Answer: 2 years after the study is completed or discontinued, or 2 years after FDA approval

21 CFR 312.62(c) requires investigators to retain records for 2 years following the date a marketing application is approved or 2 years after the investigation is discontinued.

When a protocol deviation is identified during a monitoring visit, the Clinical Research Associate (CRA) should FIRST:

Answer: Document the finding in the monitoring report and discuss corrective actions with the PI

The CRA should document the finding in the monitoring report and work with the investigator to implement corrective and preventive actions (CAPA), per standard sponsor monitoring procedures.