Protocol Deviations & Amendments Flashcards

What is a protocol deviation in the context of clinical research?

Answer: Any unplanned departure from the procedures defined in the approved protocol

A protocol deviation is any unplanned departure from the approved procedures outlined in the study protocol.

Which of the following BEST distinguishes a protocol violation from a protocol deviation?

Answer: Violations significantly affect participant safety or data integrity; deviations are minor departures

Protocol violations are deviations that significantly affect participant rights, safety, welfare, or data integrity, whereas deviations are typically minor departures.

When must a protocol amendment be submitted to the IRB for review and approval?

Answer: Before implementing any change to the approved protocol

Per ICH GCP E6(R2), any amendments to the protocol must be submitted to the IRB and approved before implementation, unless an immediate safety deviation is required.

Which type of protocol deviation typically requires immediate reporting to the sponsor?

Answer: Deviations that affect participant safety or data integrity

Deviations that may affect participant safety or the integrity of study data require prompt reporting to the sponsor per GCP guidelines.

What is the FIRST action a CRC should take upon identifying a protocol deviation?

Answer: Document the deviation and notify the principal investigator

The first step is to document the deviation thoroughly and notify the PI, who is ultimately responsible for protocol compliance at the site.

A participant received a study drug dose 20% higher than specified in the protocol due to a calculation error. This event is BEST classified as:

Answer: A protocol deviation requiring documentation and reporting to the sponsor

An incorrect dosing error is a protocol deviation (and likely a major one) that must be documented and reported to the sponsor and potentially the IRB.

Protocol amendments that increase risk to participants or substantially change the study design are classified as:

Answer: Significant amendments requiring full IRB board review

Amendments that increase participant risk or substantially alter the study design require full IRB board review rather than expedited or administrative review.