CPI Quality Assurance & Improvement 2 — Questions and Answers
Question 1: Which audit methodology involves evaluating a research site's processes BEFORE a significant regulatory inspection to identify gaps?
- Reactive audit
- Mock inspection (Correct answer)
- Surveillance audit
- Certification audit
Correct answer: Mock inspection
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:
- Assigning blame to the responsible staff member
- Preventing recurrence through systemic process changes (Correct answer)
- Documenting the deviation in the subject's chart only
- Notifying the sponsor as the sole corrective action
Correct answer: Preventing recurrence through systemic process changes
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:
- Immediately suspend the study
- Conduct a root cause analysis (Correct answer)
- Retrain all site personnel
- Report to FDA without further investigation
Correct answer: Conduct a root cause analysis
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?
- Investigator's Brochure
- Monitoring Plan (Correct answer)
- Site Initiation Visit agenda
- Protocol Amendment
Correct answer: Monitoring Plan
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:
- Eliminating all on-site monitoring visits
- Focusing oversight resources on the highest-risk data and processes (Correct answer)
- Requiring more frequent SDV of all data points
- Replacing the IRB review process
Correct answer: Focusing oversight resources on the highest-risk data and processes
RBQM concentrates monitoring efforts where risks to subject safety and data integrity are greatest rather than applying uniform oversight to all activities.
Question 6: A key performance indicator (KPI) used to measure data entry quality at a clinical site is:
- Number of adverse events reported
- Query rate per 100 data fields entered (Correct answer)
- Volume of informed consent forms collected
- Number of sponsor visits completed
Correct answer: Query rate per 100 data fields entered
Query rate measures how often entered data requires clarification, directly reflecting the accuracy and completeness of data entry practices.
Question 7: Under 21 CFR Part 11, electronic records used in clinical research must include which quality control feature?
- Color-coded data fields for ease of reading
- Audit trail capturing who made changes and when (Correct answer)
- Biometric fingerprint login only
- Paper backup printed weekly
Correct answer: Audit trail capturing who made changes and when
21 CFR Part 11 requires a secure, computer-generated audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records.
CPI Quality Assurance & Improvement 2
Which audit methodology involves evaluating a research site's processes BEFORE a significant regulatory inspection to identify gaps?