System validation, coding dictionaries and data migration MCQs With Answer

Introduction: This quiz set covers key concepts in system validation, coding dictionaries, and data migration tailored for M.Pharm students studying Clinical Research (MPP 104T). It emphasizes practical and regulatory principles required for validating computerized systems used in clinical trials, selecting and applying medical and drug coding dictionaries (e.g., MedDRA, WHO‑DRUG, ATC), and planning and validating data migration between systems. Questions focus on lifecycle stages, risk‑based approaches, testing strategies (IQ/OQ/PQ, UAT), mapping and reconciliation techniques, audit trails, and documentation requirements that ensure data integrity and regulatory compliance. These MCQs are designed to reinforce understanding and prepare students for real‑world implementation and inspections.

Q1. What is the primary objective of Computerized System Validation (CSV) in clinical research?

• To improve software user interface aesthetics
• To document and ensure systems perform consistently and comply with regulations
• To reduce the cost of IT infrastructure
• To eliminate the need for SOPs

Correct Answer: To document and ensure systems perform consistently and comply with regulations

Q2. Which validation activity typically verifies that installation was performed according to specifications?

• Performance Qualification (PQ)
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• User Acceptance Testing (UAT)

Correct Answer: Installation Qualification (IQ)

Q3. In a risk‑based approach to validation, what is the main factor used to determine the scope and intensity of testing?

• The number of users of the system
• The perceived popularity of the software vendor
• Potential impact on patient safety, data integrity, and trial outcomes
• The cost of the validation team

Correct Answer: Potential impact on patient safety, data integrity, and trial outcomes

Q4. Which of the following is a widely used adverse event coding dictionary in clinical trials?

• SNOMED CT
• MedDRA
• RxNorm
• LOINC

Correct Answer: MedDRA

Q5. What is the purpose of mapping during data migration?

• To change the database engine
• To define how source fields correspond to target fields and transform values as needed
• To design the user interface for the new system
• To conduct user training

Correct Answer: To define how source fields correspond to target fields and transform values as needed

Q6. Which activity is essential to demonstrate that a migration transferred all records accurately?

• Code optimization
• Data reconciliation and validation checks (record counts and value comparisons)
• Vendor financial audit
• Marketing analysis

Correct Answer: Data reconciliation and validation checks (record counts and value comparisons)

Q7. Which WHO‑recommended dictionary classifies drugs by therapeutic use and chemical characteristics?

• MedDRA
• WHO‑DRUG and ATC (Anatomical Therapeutic Chemical)
• ICD‑10
• SNOMED CT

Correct Answer: WHO‑DRUG and ATC (Anatomical Therapeutic Chemical)

Q8. What is an audit trail in the context of validated clinical systems?

• A list of software developers
• A sequential record showing who performed data actions, what was changed, and when
• A backup copy of the database
• A training log for end users

Correct Answer: A sequential record showing who performed data actions, what was changed, and when

Q9. Which test phase focuses on confirming the system meets user requirements in real‑world scenarios?

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• User Acceptance Testing (UAT)
• Performance Qualification (PQ)

Correct Answer: User Acceptance Testing (UAT)

Q10. When coding concomitant medications in a clinical trial, which practice ensures consistency?

• Letting each site code freely without a standard
• Using a predefined coding dictionary and controlled coding rules
• Coding only brand names and ignoring generics
• Allowing free‑text entries only

Correct Answer: Using a predefined coding dictionary and controlled coding rules

Q11. During migration, what is a common method to handle legacy free‑text adverse event terms for consistent analysis?

• Leave them unconverted to preserve original wording
• Map and code them to standardized dictionary terms (e.g., MedDRA preferred terms)
• Delete duplicate entries without review
• Convert all text to uppercase only

Correct Answer: Map and code them to standardized dictionary terms (e.g., MedDRA preferred terms)

Q12. Which document outlines the strategy, tools, test cases, and acceptance criteria for a migration project?

• Data Migration Plan
• Clinical Study Report
• Informed Consent Form
• Marketing Authorization Application

Correct Answer: Data Migration Plan

Q13. What does PQ (Performance Qualification) typically verify in system validation?

• The system is correctly installed
• The system operational limits under load and real‑world scenarios meet user needs
• The software vendor’s financial stability
• The grammar used in system help files

Correct Answer: The system operational limits under load and real‑world scenarios meet user needs

Q14. Which of the following best describes a controlled terminology in clinical data management?

• Random terms invented by sites
• A predefined set of allowed values to ensure consistent data capture and analysis
• Terms used only in marketing materials
• Informal shorthand used by individual monitors

Correct Answer: A predefined set of allowed values to ensure consistent data capture and analysis

Q15. What is a primary regulatory expectation for validated systems used in clinical trials?

• Always be open source
• Have documented requirements, risk assessment, testing evidence, and change control
• Be hosted in a single country
• Never be updated after initial deployment

Correct Answer: Have documented requirements, risk assessment, testing evidence, and change control

Q16. When converting coded data between dictionaries (e.g., legacy codes to MedDRA), what is crucial to maintain?

• Only the code numbers without descriptions
• Traceability between original source terms and the new coded values
• Delete all unmappable terms
• Change coding rules mid‑project

Correct Answer: Traceability between original source terms and the new coded values

Q17. In validation, what is the role of a traceability matrix?

• To track vendor invoices
• To map user requirements to design, tests, and validation artifacts ensuring coverage
• To record meeting minutes
• To schedule training sessions

Correct Answer: To map user requirements to design, tests, and validation artifacts ensuring coverage

Q18. Which of the following is a key success factor for a data migration project in clinical research?

• Skipping testing to save time
• Early stakeholder involvement, clear mapping rules, and iterative testing
• Relying solely on automatic conversion without review
• Performing migration only after database locks are removed

Correct Answer: Early stakeholder involvement, clear mapping rules, and iterative testing

Q19. Which validation deliverable demonstrates that tests were executed and met acceptance criteria?

• Validation Test Report
• Vendor marketing brochure
• Budget spreadsheet
• Training attendance list

Correct Answer: Validation Test Report

Q20. What is the recommended approach to maintain dictionary versions (e.g., MedDRA) across an ongoing clinical program?

• Never update the dictionary once chosen
• Establish a controlled versioning policy, plan for updates, and document mapping impacts
• Allow each site to choose its preferred dictionary version
• Update the dictionary weekly without testing

Correct Answer: Establish a controlled versioning policy, plan for updates, and document mapping impacts

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