CPI Quality Assurance & Improvement 3

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?

Accepted Answer

Quality by Design (QbD)

Answer

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:

Accepted Answer

Provides an independent assessment of GCP compliance

Answer

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?

Accepted Answer

Serious or major deviation affecting subject safety or data integrity

Answer

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:

Accepted Answer

Original source records to transcribed data in the CRF or EDC

Answer

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:

Accepted Answer

Value stream map

Answer

Value stream mapping visualizes the entire flow of a process to identify non-value-adding steps, delays, and opportunities for improvement.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Quality Assurance & Improvement 3