CPI Quality Assurance & Improvement 2

Question 1

Which audit methodology involves evaluating a research site's processes BEFORE a significant regulatory inspection to identify gaps?

Accepted Answer

Mock inspection

Answer

A mock inspection simulates a regulatory authority visit to proactively identify and correct deficiencies before the real inspection.

Question 2

A CAPA plan for a protocol deviation should PRIMARILY focus on:

Accepted Answer

Preventing recurrence through systemic process changes

Answer

Effective CAPA addresses root causes through systemic improvements to prevent the same deviation from recurring.

Question 3

When a quality indicator trend shows increasing protocol deviation rates over three consecutive months, the FIRST appropriate step is to:

Accepted Answer

Conduct a root cause analysis

Answer

Root cause analysis must precede any corrective action to ensure interventions target the actual source of the problem.

Question 4

Which document type provides the sponsor's detailed expectations for site monitoring visit frequency and procedures?

Accepted Answer

Monitoring Plan

Answer

The Monitoring Plan outlines the sponsor's risk-based strategy for oversight including visit frequency, scope, and required documentation reviews.

Question 5

Risk-Based Quality Management (RBQM) differs from traditional monitoring primarily by:

Accepted Answer

Focusing oversight resources on the highest-risk data and processes

Answer

RBQM concentrates monitoring efforts where risks to subject safety and data integrity are greatest rather than applying uniform oversight to all activities.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Quality Assurance & Improvement 2