Protocol Deviations & Amendments Flashcards

A protocol amendment that changes the primary study endpoint requires:

Answer: IRB review and approval before implementation at the site

Changes to primary endpoints are substantive amendments that require IRB review and approval before the site can implement them.

Which of the following is an example of a MINOR protocol deviation?

Answer: A study visit completed one day outside the allowed window with no impact on data quality

A visit completed one day outside the window with no impact on participant safety or data integrity is typically classified as a minor deviation.

Under which circumstance may a site implement a protocol change BEFORE receiving formal IRB approval?

Answer: When the change is needed to eliminate an immediate hazard to participants

ICH GCP E6(R2) Section 4.5.2 permits immediate implementation of changes needed to eliminate immediate hazards to participants, with retroactive IRB reporting.

Which of the following information must be included in a deviation report submitted to the sponsor?

Answer: Description of the deviation, date, impact on safety and data, and corrective/preventive actions taken

A complete deviation report includes the nature of the deviation, when it occurred, its impact on safety and data integrity, and the corrective and preventive actions taken.

Protocol deviations that affect participant safety must typically be reported to the IRB within:

Answer: The timeframe specified by the IRB's own policies, often within 5–10 business days

IRBs typically require prompt reporting of deviations affecting safety within their specified timeframes, which are often measured in business days rather than months.

Which section of the ICH GCP E6(R2) guideline specifically addresses clinical trial protocol content and protocol amendments?

Answer: Section 6 — Clinical Trial Protocol and Protocol Amendment(s)

ICH GCP E6(R2) Section 6 covers the required content and regulatory requirements for the clinical trial protocol and its amendments.

After identifying a repeated pattern of the same protocol deviation at a site, the CRC and PI should FIRST:

Answer: Conduct a root cause analysis and implement a CAPA (Corrective and Preventive Action) plan

A CAPA plan developed after root cause analysis is the standard quality improvement response to recurring deviations in clinical research.