Protocol Deviations & Amendments Flashcards

Which document is primarily used at a clinical research site to track and manage protocol deviations?

Answer: Protocol Deviation Log

A Protocol Deviation Log is maintained at the site to systematically track, categorize, and manage all deviations from the approved protocol.

A study participant completed a required blood draw 5 days outside the protocol-specified visit window. This is an example of:

Answer: A protocol deviation

Missing a required assessment window is a common type of protocol deviation that must be documented in the site's deviation log.

A protocol deviation rises to the level of a protocol violation when it:

Answer: Affects participant safety, rights, or data integrity

Deviations rise to the level of violations when they compromise participant safety, rights, welfare, or the integrity of collected data.

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

Answer: Enrollment of a participant who did not meet all inclusion criteria

Enrolling a participant who does not meet eligibility criteria is a major deviation because it may affect data integrity and participant safety.

Under FDA regulations (21 CFR 312.62), how long must clinical trial records generally be retained after the study is completed?

Answer: At least 2 years after the investigational product's marketing application is approved or investigations discontinued

FDA regulations require that records be retained for at least 2 years after a marketing application is approved or clinical investigations are discontinued.

Which regulatory body must IND sponsors notify when serious or unexpected protocol deviations occur in the United States?

Answer: FDA (Food and Drug Administration)

Under 21 CFR Part 312, IND sponsors must report significant protocol deviations and safety issues to the FDA.

A CRC discovers that a protocol deviation occurred 2 weeks ago but was never documented. The BEST course of action is to:

Answer: Document the deviation now with a note explaining the delay and notify the PI

Late documentation is always better than no documentation; the CRC should document the deviation with an explanation of the delay and escalate appropriately to the PI.