CCRC Protocol Deviations & Amendments 2

Question 1

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

Accepted Answer

Protocol Deviation Log

Answer

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

Question 2

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

Accepted Answer

A protocol deviation

Answer

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

Question 3

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

Accepted Answer

Affects participant safety, rights, or data integrity

Answer

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

Question 4

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

Accepted Answer

Enrollment of a participant who did not meet all inclusion criteria

Answer

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

Question 5

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

Accepted Answer

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

Answer

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

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC Protocol Deviations & Amendments 2