CCRC Protocol Deviations & Amendments 3

Question 1

A protocol amendment that changes the primary study endpoint requires:

Accepted Answer

IRB review and approval before implementation at the site

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

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

Answer

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

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC Protocol Deviations & Amendments 3