SOCRA Protocol Deviations and Violations 1

Question 1

Which of the following BEST defines a protocol deviation in a clinical trial?

Accepted Answer

An unplanned departure from the procedures described in the approved protocol

Answer

Any change to the protocol that is approved by the sponsor in advance

Answer

A formal amendment to the protocol submitted to the IRB

Answer

A sponsor-initiated modification to study eligibility criteria

Question 2

A subject enrolled in a clinical trial misses a required blood draw by 5 days due to a personal emergency. How should the Clinical Research Coordinator (CRC) handle this?

Accepted Answer

Document the missed visit as a protocol deviation and notify the PI and sponsor

Answer

Remove the subject from the study immediately

Answer

Reschedule the draw without documenting the variance

Answer

Obtain a retroactive protocol amendment from the IRB

Question 3

Under ICH E6(R2) Good Clinical Practice, which party bears primary responsibility for ensuring protocol compliance at the investigative site?

Accepted Answer

The Principal Investigator (PI)

Answer

The sponsor's Clinical Research Associate (CRA)

Answer

The Institutional Review Board (IRB)

Answer

The FDA district office

Question 4

Which of the following protocol deviations would MOST likely be classified as a major (significant) deviation requiring prompt IRB reporting?

Accepted Answer

An ineligible subject was enrolled because inclusion criteria were not properly verified

Answer

A subject's study visit occurred 2 days outside the allowed visit window

Answer

A required quality-of-life questionnaire was administered in a different order than specified

Answer

A laboratory sample was processed 30 minutes later than the protocol specified

Question 5

What is the PRIMARY distinction between a protocol deviation and a protocol violation?

Accepted Answer

A violation is a deviation that significantly affects subject safety or data integrity

Answer

Violations involve unapproved drug doses; deviations involve missed visits only

Answer

Violations are intentional departures while deviations are unintentional

Answer

Deviations require FDA reporting while violations are only reported to the IRB

Question 6

According to FDA regulations at 21 CFR 312.62, how long must an investigator retain records of protocol deviations for drugs studied under an IND?

Accepted Answer

2 years after the study is completed or discontinued, or 2 years after FDA approval

Answer

1 year after study completion

Answer

5 years after the last subject visit

Answer

7 years after the last enrolled subject completes the study

Question 7

When a protocol deviation is identified during a monitoring visit, the Clinical Research Associate (CRA) should FIRST:

Accepted Answer

Document the finding in the monitoring report and discuss corrective actions with the PI

Answer

Report the deviation directly to the FDA without notifying the site

Answer

Suspend all study activities at the site until the deviation is resolved

Answer

Immediately notify the IRB before informing the sponsor