CPI Quality Assurance & Improvement 3 — Questions and Answers
Question 1: Which ICH E6(R2) GCP principle specifically addresses the need for quality to be built into a clinical trial rather than inspected in after completion?
- Principle of data confidentiality
- Quality by Design (QbD) (Correct answer)
- Source Data Verification mandate
- Blinding requirement for randomized trials
Correct answer: Quality by Design (QbD)
ICH E6(R2) emphasizes Quality by Design, meaning quality systems and risk controls should be embedded in trial processes from the planning stage.
Question 2: A sponsor's clinical quality assurance (CQA) audit of a site differs from a monitor's routine visit in that a CQA audit:
- Focuses only on financial record accuracy
- Provides an independent assessment of GCP compliance (Correct answer)
- Approves new protocol amendments
- Replaces the IRB's continuing review
Correct answer: Provides an independent assessment of GCP compliance
A CQA audit is an independent, systematic examination by the sponsor's quality assurance function to determine GCP compliance, separate from ongoing monitoring activities.
Question 3: When classifying a protocol deviation, which category requires immediate reporting to the IRB in most cases?
- Administrative deviation
- Minor deviation with no safety impact
- Serious or major deviation affecting subject safety or data integrity (Correct answer)
- Deviation discovered and self-corrected before any impact
Correct answer: Serious or major deviation affecting subject safety or data integrity
Serious or major deviations that may affect subject safety, rights, or welfare, or the integrity of study data, typically require prompt IRB reporting per regulations.
Question 4: Source Data Verification (SDV) is defined as the process of comparing:
- CRF entries to the protocol requirements
- Original source records to transcribed data in the CRF or EDC (Correct answer)
- Audit trail entries to the investigator's log
- IRB approval letters to the sponsor contract
Correct answer: Original source records to transcribed data in the CRF or EDC
SDV involves reviewing original source documents (medical records, lab reports) against the data recorded in the case report form to confirm accuracy and completeness.
Question 5: A process improvement tool that visually maps all steps in a clinical trial workflow to identify inefficiencies and waste is called a:
- Fishbone diagram
- Value stream map (Correct answer)
- Pareto chart
- Control chart
Correct answer: Value stream map
Value stream mapping visualizes the entire flow of a process to identify non-value-adding steps, delays, and opportunities for improvement.
Question 6: Essential documents that must be available before a clinical trial can begin include all of the following EXCEPT:
- Signed protocol and amendments
- IRB approval of the protocol
- Investigator's Brochure
- Final study report (Correct answer)
Correct answer: Final study report
The final study report is generated after trial completion and is not an essential document required before trial initiation.
Question 7: Which statistical process control tool plots individual data points over time to detect when a process goes out of control?
- Histogram
- Scatter diagram
- Control chart (Correct answer)
- Cause-and-effect diagram
Correct answer: Control chart
Control charts plot data over time with upper and lower control limits to identify trends, shifts, or out-of-control variation in a process.
CPI Quality Assurance & Improvement 3
Which ICH E6(R2) GCP principle specifically addresses the need for quality to be built into a clinical trial rather than inspected in after completion?