Quality assurance and quality control in clinical trials MCQs With Answer

Introduction: This set of MCQs on Quality Assurance (QA) and Quality Control (QC) in Clinical Trials is designed for M.Pharm students preparing for the Clinical Research (MPP 104T) exam. The questions focus on core concepts such as Good Clinical Practice (GCP), monitoring, audit procedures, documentation, data integrity, corrective and preventive actions (CAPA), risk management, sponsor and investigator responsibilities, and QC in clinical laboratories. Each item tests both theoretical understanding and practical application relevant to trial conduct and regulatory inspections. Use these questions to reinforce learning, identify gaps, and prepare for higher-level problem-solving in quality systems applied to clinical research.

Q1. What is the primary objective of Quality Assurance (QA) in clinical trials?

• To perform laboratory testing of clinical samples
• To ensure that trial processes and results comply with GCP and regulatory requirements
• To recruit participants for the study
• To design the clinical protocol

Correct Answer: To ensure that trial processes and results comply with GCP and regulatory requirements

Q2. Which activity is mainly considered a Quality Control (QC) function?

• Conducting a system-wide audit of trial management
• Developing SOPs for the clinical site
• Testing and verifying assay performance for sample analysis
• Performing root cause analysis for observed trends

Correct Answer: Testing and verifying assay performance for sample analysis

Q3. Which of the following best describes an audit in clinical research?

• A routine monitoring visit to ensure patient safety
• An independent, systematic evaluation of trial activities and records to determine compliance
• The process of analyzing biological samples in a lab
• Training of site staff on protocol procedures

Correct Answer: An independent, systematic evaluation of trial activities and records to determine compliance

Q4. What does CAPA stand for and what is its purpose?

• Control and Performance Assessment; to validate lab instruments
• Corrective and Preventive Actions; to address nonconformities and prevent recurrence
• Clinical Audit and Performance Analysis; to monitor patient outcomes
• Compliance and Protocol Assessment; to review study designs

Correct Answer: Corrective and Preventive Actions; to address nonconformities and prevent recurrence

Q5. Which principle is central to data integrity in clinical trials (ALCOA+)?

• Accessible, Logical, Consistent, Organized, Accurate
• Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Enduring, Available
• Analytical, Lab-based, Controlled, Observational, Auditable
• Authorized, Licensed, Compliant, Open, Archived

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Enduring, Available

Q6. During an inspection, which document is essential to demonstrate that informed consent was properly obtained?

• Study protocol
• Investigator’s brochure
• Completed informed consent forms and consent logs
• Case report form templates

Correct Answer: Completed informed consent forms and consent logs

Q7. What is the main difference between monitoring and auditing in clinical trials?

• Monitoring checks lab assays; auditing recruits subjects
• Monitoring is routine and site-focused to ensure data accuracy and subject safety; auditing is independent and broader to assess compliance and systems
• Monitoring only occurs pre-study; auditing only occurs post-study
• There is no difference; both terms are interchangeable

Correct Answer: Monitoring is routine and site-focused to ensure data accuracy and subject safety; auditing is independent and broader to assess compliance and systems

Q8. Which document typically defines roles and responsibilities between a sponsor and a CRO?

• Investigator brochure
• Clinical study report
• Contract and delegation of authority log
• Informed consent form

Correct Answer: Contract and delegation of authority log

Q9. In QC for a clinical laboratory, what is the purpose of method validation?

• To train new laboratory staff
• To demonstrate that an analytical method is suitable for its intended purpose with acceptable accuracy, precision, specificity, and robustness
• To create audit trails for instruments
• To ensure informed consent is signed for sample storage

Correct Answer: To demonstrate that an analytical method is suitable for its intended purpose with acceptable accuracy, precision, specificity, and robustness

Q10. Which of the following is a critical element of Good Clinical Practice (GCP)?

• Random number generation only
• Ensuring participant rights, safety, and well-being and that trial data are credible
• Maximizing recruitment irrespective of inclusion criteria
• Performing all lab tests in a single central lab

Correct Answer: Ensuring participant rights, safety, and well-being and that trial data are credible

Q11. What is a Source Data Verification (SDV) activity conducted by monitors?

• Verifying that lab instruments are calibrated
• Comparing entries in the case report form (CRF) with original source documents to ensure accuracy
• Checking sponsor financial records
• Reviewing the study protocol for typos

Correct Answer: Comparing entries in the case report form (CRF) with original source documents to ensure accuracy

Q12. Which corrective action would be most appropriate after identifying repeated protocol deviations at a site?

• Terminate the study immediately at all sites
• Implement targeted retraining, revise SOPs if needed, and increase monitoring frequency
• Ignore deviations if outcomes are unaffected
• Change the primary endpoint to avoid detection of deviations

Correct Answer: Implement targeted retraining, revise SOPs if needed, and increase monitoring frequency

Q13. How does risk-based monitoring (RBM) improve QA in clinical trials?

• By eliminating the need for any on-site visits
• By focusing monitoring resources on critical data, processes, and high-risk sites to optimize oversight
• By standardizing all site visits to identical checklists
• By outsourcing monitoring to non-clinical personnel

Correct Answer: By focusing monitoring resources on critical data, processes, and high-risk sites to optimize oversight

Q14. What constitutes an audit trail in an electronic trial master file (eTMF) or EDC system?

• A printed copy of each document
• Automatic, secure records showing who made changes, what was changed, when, and why
• Handwritten notes kept by monitors
• Monthly summaries without timestamps

Correct Answer: Automatic, secure records showing who made changes, what was changed, when, and why

Q15. Which regulatory requirement relates specifically to electronic records and signatures in the US?

• ICH E6(R2)
• 21 CFR Part 11
• EMA Annex 11 only applies in Europe and not relevant
• ICH Q10

Correct Answer: 21 CFR Part 11

Q16. What is the role of trend analysis in QA/QC for clinical trials?

• To monitor long-term patterns in deviations, adverse events, or quality metrics to enable preventive actions
• To randomly select subjects for additional testing
• To evaluate investigator CVs annually
• To document each monitoring visit

Correct Answer: To monitor long-term patterns in deviations, adverse events, or quality metrics to enable preventive actions

Q17. Which of the following is an example of a critical quality attribute (CQA) in clinical laboratory assays?

• Time of day the sample was signed into chain of custody
• Assay specificity for the analyte of interest
• Color of the reagent bottle cap
• Font used in the CRF

Correct Answer: Assay specificity for the analyte of interest

Q18. In the context of clinical trials, what is documented evidence that a deviation was accepted and risk-assessed called?

• Protocol amendment
• Deviation log with justification and risk assessment
• Informed consent re-signature
• Recruitment log update

Correct Answer: Deviation log with justification and risk assessment

Q19. Which activity is primarily aimed at ensuring the reliability of laboratory results across different sites or labs?

• Investigator meeting
• Inter-laboratory proficiency testing and method transfer assessments
• Source data verification
• Patient randomization

Correct Answer: Inter-laboratory proficiency testing and method transfer assessments

Q20. What is the most appropriate documentation practice when correcting an entry in a paper source document at a clinical site?

• Erase the original and write the correct value without note
• Strike through the incorrect entry so it remains legible, date and sign the correction, and provide reason if required
• Obliterate the page and rewrite the page
• Ask the sponsor to make the correction remotely

Correct Answer: Strike through the incorrect entry so it remains legible, date and sign the correction, and provide reason if required

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