CRF and database design, data entry and cleaning processes MCQs With Answer

Introduction

CRF and database design, data entry and cleaning processes MCQs With Answer is a focused quiz resource tailored for M.Pharm students studying Clinical Research (MPP 104T). This collection emphasizes practical and regulatory aspects of Case Report Form (CRF) design, electronic CRF (eCRF) systems, database architecture, validation, edit checks, query management, and systematic data cleaning. Each question probes deeper topics such as metadata, audit trail requirements, SDV, 21 CFR Part 11, CDISC standards, and database lock procedures. The goal is to reinforce conceptual understanding and application skills required for accurate, compliant clinical data capture and downstream analysis in pharmaceutical research.

Q1. What is the primary purpose of a Case Report Form (CRF) in a clinical trial?

• To randomize subjects to treatment groups
• To collect protocol-required data for each enrolled subject
• To serve as the final statistical analysis dataset
• To document marketing approvals

Correct Answer: To collect protocol-required data for each enrolled subject

Q2. Which principle is most important when designing a CRF to ensure high-quality data capture?

• Include as many open-text fields as possible to allow flexibility
• Design forms with logical clinical flow and minimize free-text entries
• Separate related data across many small forms to reduce page length
• Use complex branching that relies on manual skip logic only

Correct Answer: Design forms with logical clinical flow and minimize free-text entries

Q3. What is a major advantage of an electronic CRF (eCRF) compared with paper CRF?

• Eliminates the need for any monitoring or source verification
• Provides real-time edit checks and programmed data validation
• Makes audit trails optional
• Automatically produces regulatory submission datasets without configuration

Correct Answer: Provides real-time edit checks and programmed data validation

Q4. Which of the following best describes metadata in a clinical database context?

• Patient consent forms stored as scanned documents
• Variable name, field type, and permissible values used to describe each data item
• Printed CRF pages filed in the investigator site binder
• Final statistical outputs such as p-values and tables

Correct Answer: Variable name, field type, and permissible values used to describe each data item

Q5. What is an edit check in the context of a clinical trial database?

• A written SOP describing how to collect laboratory data
• A programmed validation that flags missing, inconsistent, or out-of-range entries
• A paper CRF version number printed on the form
• An audit finding reported during an inspection

Correct Answer: A programmed validation that flags missing, inconsistent, or out-of-range entries

Q6. Why is double data entry used in some data entry workflows?

• To speed up database lock by entering data twice as fast
• To detect and reduce transcription errors by reconciling two independent entries
• To meet CDISC SDTM formatting requirements automatically
• To avoid the need for source data verification

Correct Answer: To detect and reduce transcription errors by reconciling two independent entries

Q7. 21 CFR Part 11 primarily regulates which aspect of clinical trial systems?

• Clinical trial protocol development
• Electronic records and electronic signatures to ensure trustworthiness
• Drug manufacturing facility inspections
• Statistical analysis plan content

Correct Answer: Electronic records and electronic signatures to ensure trustworthiness

Q8. What information does an audit trail in an EDC system typically record?

• Only the final value entered for each field
• Who made the change, when it was made, and what the previous value was
• The list of users with access to the system but not their actions
• Only queries raised but not their resolutions

Correct Answer: Who made the change, when it was made, and what the previous value was

Q9. What does SDV (Source Data Verification) refer to?

• Standardized data values in the submission datasets
• Comparing CRF/eCRF entries against the original source documents to confirm accuracy
• Software development validation for EDC systems
• Statistical data validation performed after database lock

Correct Answer: Comparing CRF/eCRF entries against the original source documents to confirm accuracy

Q10. Which statement best defines database lock?

• A temporary freeze while data entry continues without queries
• The point at which the database is declared final and no further changes are allowed except documented releases
• A nightly backup of the database
• A report showing outstanding queries only

Correct Answer: The point at which the database is declared final and no further changes are allowed except documented releases

Q11. What is the primary purpose of query management in clinical data handling?

• To generate analytical datasets for modeling
• To raise, track, and resolve discrepancies between entered data and protocol/source documentation
• To perform statistical hypothesis testing
• To encrypt data for transmission

Correct Answer: To raise, track, and resolve discrepancies between entered data and protocol/source documentation

Q12. Which sequence best represents the iterative data cleaning process?

• Generate SDTM → Lock database → Run edit checks
• Run programmed edit checks → Raise queries → Resolve and document corrections → Re-run checks
• Lock database → Perform source verification → Create audit trail
• Collect CRFs → Publish results → Archive database

Correct Answer: Run programmed edit checks → Raise queries → Resolve and document corrections → Re-run checks

Q13. Why is CRF version control important?

• It allows investigators to change protocol requirements without approval
• It tracks changes to CRF content so data collected under different versions can be identified and reconciled
• It replaces the need for a data management plan
• It is only required for paper CRFs, not eCRFs

Correct Answer: It tracks changes to CRF content so data collected under different versions can be identified and reconciled

Q14. Which best differentiates a CRF from source documents?

• CRF is the original laboratory instrument readout; source documents are copies
• CRF is designed to capture protocol-required data in a structured way; source documents are the original clinical records and notes
• CRF includes audit trails; source documents never change
• CRF holds patient identifiers only while source documents contain study results

Correct Answer: CRF is designed to capture protocol-required data in a structured way; source documents are the original clinical records and notes

Q15. What type of check is a “range check” in data validation?

• Checks that a field was completed by the site monitor
• Validates that a numeric entry falls within predefined lower and upper bounds
• Verifies that the user has appropriate role-based access
• Ensures that database backups are performed daily

Correct Answer: Validates that a numeric entry falls within predefined lower and upper bounds

Q16. Which activities are typically included in EDC system validation for clinical trials?

• Writing the clinical study report and regulatory submissions
• Developing test scripts, executing test cases (including UAT), and documenting results and traceability
• Training site staff only after database lock
• Automatically converting paper CRFs to SDTM without testing

Correct Answer: Developing test scripts, executing test cases (including UAT), and documenting results and traceability

Q17. What is the primary reason for implementing role-based access controls in an EDC?

• To allow all users to edit any subject’s data
• To ensure segregation of duties and limit system functions according to user responsibilities
• To comply with CDISC submission formatting
• To automatically anonymize data for submission

Correct Answer: To ensure segregation of duties and limit system functions according to user responsibilities

Q18. Which action is a standard method for de-identifying clinical trial subject data before analysis?

• Replacing direct identifiers with a subject code and removing unique identifiers where possible
• Keeping full names and dates to preserve context
• Publishing subject contact details with the dataset
• Converting all numeric values into free-text fields

Correct Answer: Replacing direct identifiers with a subject code and removing unique identifiers where possible

Q19. How does CDISC SDTM differ from ADaM?

• SDTM defines analysis-ready datasets, while ADaM defines raw source tables
• SDTM provides standardized submission datasets representing collected data; ADaM provides analysis datasets designed to support statistical analyses
• SDTM is used only for nonclinical studies, ADaM only for clinical studies
• They are interchangeable terms for the same dataset structure

Correct Answer: SDTM provides standardized submission datasets representing collected data; ADaM provides analysis datasets designed to support statistical analyses

Q20. What is the purpose of define.xml in regulatory submissions?

• It contains the audit trail for the EDC system
• It documents metadata and structure of submitted datasets to allow reviewers to understand variable definitions and derivations
• It stores scanned informed consent forms
• It is used only for archiving paper CRFs

Correct Answer: It documents metadata and structure of submitted datasets to allow reviewers to understand variable definitions and derivations

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