SOCRA Protocol Deviations and Violations 2

Question 1

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

Accepted Answer

Obtaining IRB approval to temporarily waive a procedure before it is missed

Answer

A prospective deviation occurs when the site identifies a potential departure in advance and obtains appropriate approvals or waivers before the scheduled procedure.

Question 2

A subject on a clinical trial inadvertently received a double dose of the investigational product. What is the MOST appropriate immediate action?

Accepted Answer

Assess subject safety, report as an adverse event if applicable, and document as a protocol deviation

Answer

A dosing error must trigger immediate safety assessment, adverse event reporting if warranted, and documentation as a protocol deviation, with notification to the PI, sponsor, and IRB per their requirements.

Question 3

Under 21 CFR Part 312, which of the following protocol deviations requires prompt reporting to the FDA?

Accepted Answer

Changes to eliminate immediate hazards to subjects, reported as soon as possible

Answer

21 CFR 312.62 and ICH E6 both require that protocol changes implemented to eliminate immediate hazards be reported to the FDA and IRB as soon as possible after the changes are made.

Question 4

Which element is MOST important to include in a protocol deviation report submitted to the IRB?

Accepted Answer

A description of the deviation, the impact on subject safety/data integrity, and corrective actions taken

Answer

IRB deviation reports must describe what occurred, assess the impact on subject safety and data integrity, and outline corrective/preventive actions to be taken.

Question 5

A CAPA (Corrective and Preventive Action) plan is developed in response to a protocol deviation. What is the PRIMARY purpose of the 'preventive' component?

Accepted Answer

To identify and address root causes to prevent recurrence of similar deviations

Answer

The preventive component of a CAPA focuses on identifying the root cause of the deviation and implementing systemic changes to prevent similar events from recurring.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Protocol Deviations and Violations 2