SOCRA Protocol Deviations and Violations 4

Question 1

Under ICH E6, when may an investigator implement a deviation from the protocol without prior sponsor agreement and IRB approval?

Accepted Answer

When it is needed to eliminate an immediate hazard to trial subjects

Answer

ICH E6 permits deviating without prior approval only when needed to eliminate an immediate hazard to subjects.

Question 2

After implementing an urgent deviation to protect a subject, what must the investigator do next per ICH E6?

Accepted Answer

Submit the deviation, its reasons, and any proposed amendment to the IRB, sponsor, and regulators as required, as soon as possible

Answer

ICH E6 4.5.4 requires prompt submission of the deviation, its reasons, and any proposed amendment to the IRB, sponsor, and regulatory authorities as required.

Question 3

A sponsor grants a prospective waiver allowing a site to enroll a subject who fails an inclusion criterion. How does FDA view this?

Accepted Answer

It is a protocol change that needs IRB approval before it is implemented

Answer

FDA treats prospective, intentional deviations such as eligibility waivers as protocol changes needing IRB review and approval before they are implemented.

Question 4

A subject's Week 8 visit happens 2 days outside the protocol window, with no impact on safety or key endpoints. How is this usually handled?

Accepted Answer

Documented as a minor deviation and reported per sponsor and IRB policy

Answer

Window deviations with no safety or data-integrity impact are usually minor and are documented and reported according to sponsor and IRB requirements.

Question 5

A monitor finds dosing errors happening repeatedly at one site. What is the most appropriate response?

Accepted Answer

Perform root cause analysis and carry out a CAPA plan such as retraining and process changes

Answer

Recurring deviations call for root cause analysis and corrective and preventive action to stop them from happening again.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Protocol Deviations and Violations 4