SOCRA Protocol Deviations and Violations 5

Question 1

In a Clinical Study Report structured per ICH E3, where are important protocol deviations described?

Accepted Answer

Section 10.2, Protocol Deviations

Answer

ICH E3 Section 10.2 describes important protocol deviations related to inclusion/exclusion criteria, trial conduct, patient management, or assessment.

Question 2

Per ICH E6, who is responsible for documenting and explaining any deviation from the approved protocol at the site?

Accepted Answer

The investigator or a person designated by the investigator

Answer

ICH E6 4.5.3 states that the investigator, or a person the investigator designates, should document and explain any deviation from the approved protocol.

Question 3

In a device study under 21 CFR 812.150, how soon must an investigator report an emergency deviation made to protect a subject's life or physical well-being?

Accepted Answer

No later than 5 working days after the emergency occurred

Answer

21 CFR 812.150(a)(4) requires notifying the sponsor and IRB within 5 working days of such an emergency deviation.

Question 4

How do major protocol deviations usually affect a subject's inclusion in statistical analysis populations?

Accepted Answer

The subject may be excluded from the per-protocol population but stays in the intent-to-treat population

Answer

Important deviations often exclude subjects from the per-protocol set, while ITT keeps all randomized subjects.

Question 5

A subject takes a medication the protocol prohibits, on their own and without telling the site. How should this be handled?

Accepted Answer

Documented as a protocol deviation and assessed for safety and data impact, even though the subject caused it

Answer

Deviations are documented no matter who caused them, and their impact on safety and data integrity must be assessed.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Protocol Deviations and Violations 5