Managing laboratory and ADR data; database lock procedures MCQs With Answer

Introduction: Managing laboratory and adverse drug reaction (ADR) data and understanding database lock procedures are essential skills for M.Pharm students going into clinical research and pharmacovigilance. This blog provides a focused set of multiple-choice questions to sharpen knowledge on lab data collection, source data verification, central versus local laboratory issues, coding and causality assessment of ADRs, and the operational, regulatory and technical steps involved in database lock. Emphasis is given to practical practices such as query resolution, audit trails, change control, and post-lock procedures aligned with ICH-GCP and 21 CFR Part 11 expectations. These MCQs will help reinforce both conceptual understanding and applied decision-making.

Q1. Which of the following best describes the purpose of source data verification (SDV) for laboratory results in a clinical trial?

• To recreate laboratory reports from CRF entries
• To ensure CRF entries accurately reflect original laboratory records and values
• To anonymize laboratory data before transfer
• To correct out-of-range laboratory values without documentation

Correct Answer: To ensure CRF entries accurately reflect original laboratory records and values

Q2. In a multicenter trial, what is the primary advantage of using a central laboratory over local laboratories?

• Lower shipping costs for samples
• Faster turnaround time at every site
• Standardized assays and reference ranges improving data comparability
• Elimination of need for laboratory manuals

Correct Answer: Standardized assays and reference ranges improving data comparability

Q3. Which coding dictionary is most widely used for adverse event coding in modern clinical trials?

• WHO-ART
• ICD-10
• MedDRA
• SNOMED CT

Correct Answer: MedDRA

Q4. Which item is NOT typically part of a database lock checklist?

• All critical queries resolved and documented
• Final audit trail reviewed and signed
• Blank CRFs destroyed
• Final reconciliations between lab data and CRF completed

Correct Answer: Blank CRFs destroyed

Q5. What is the correct regulatory rationale for maintaining an audit trail in an electronic clinical database?

• To allow anonymization of patient identity after lock
• To enable tracking of data changes for compliance with 21 CFR Part 11 and GCP
• To reduce electronic storage requirements
• To provide editable records for investigators post-lock

Correct Answer: To enable tracking of data changes for compliance with 21 CFR Part 11 and GCP

Q6. Which action is most appropriate when a laboratory value critical for safety is missing from the CRF but available in the lab report?

• Ignore it if the sponsor deems it non-critical
• Enter the value directly into the database without source documentation
• Raise a query to site, perform SDV, and update the CRF with documented source
• Estimate value based on previous visits and document estimation

Correct Answer: Raise a query to site, perform SDV, and update the CRF with documented source

Q7. Which of the following best describes an interim database lock?

• A permanent lock at study end that prevents any further changes
• A temporary freeze of data to allow planned analysis while ongoing data collection continues
• A physical locking of paper CRFs in a cabinet
• A lock that applies only to adverse event data

Correct Answer: A temporary freeze of data to allow planned analysis while ongoing data collection continues

Q8. When coding an ADR, which step is crucial to ensure consistency and regulatory acceptability?

• Coding solely by the site investigator
• Using a validated coding dictionary like MedDRA and following a documented coding convention
• Translating terms into local language before coding
• Avoiding queries to keep timelines short

Correct Answer: Using a validated coding dictionary like MedDRA and following a documented coding convention

Q9. Which causality assessment tool is commonly used in pharmacovigilance to provide standardized causality categories?

• Naranjo algorithm
• APACHE II score
• Framingham risk score
• Glasgow coma scale

Correct Answer: Naranjo algorithm

Q10. In the context of lab data management, what is the purpose of reconciliation?

• To merge different patients into a single record
• To compare and align laboratory dataset(s) with CRF entries and resolve discrepancies
• To anonymize lab identifiers prior to analysis
• To delete duplicate lab reports without documentation

Correct Answer: To compare and align laboratory dataset(s) with CRF entries and resolve discrepancies

Q11. Which of the following would most likely trigger an immediate unblinded review of laboratory data in a blinded trial?

• Minor elevation of ALT within expected range
• A single outlier result with no clinical symptoms
• A cluster of severe, unexpected liver enzyme elevations suggesting potential drug toxicity
• Routine chemistry results at screening

Correct Answer: A cluster of severe, unexpected liver enzyme elevations suggesting potential drug toxicity

Q12. According to ICH-GCP, who is primarily responsible for ensuring the accuracy, completeness and timeliness of the reported trial data?

• The laboratory technician
• The sponsor only
• The investigator
• The data entry vendor

Correct Answer: The investigator

Q13. What is the typical consequence of performing a full database lock without resolving known critical queries?

• Faster regulatory approval
• Potentially invalid primary analysis and regulatory non-compliance
• Automatic extension of the study timeline by regulators
• No impact if queries are few

Correct Answer: Potentially invalid primary analysis and regulatory non-compliance

Q14. Which document formally authorizes re-opening a locked database to make changes post-lock?

• Investigator brochure
• Database re-opening change control with sponsor and relevant approvals
• Unauthenticated email from a site coordinator
• Printed copy of CRFs

Correct Answer: Database re-opening change control with sponsor and relevant approvals

Q15. When preparing for final database lock, what is the importance of freeze files (deliverables)?

• They are backups that are kept secret from auditors
• They provide validated, time-stamped data extracts used for analysis and regulatory submission
• They allow sites to continue editing patient randomization
• They are used to anonymize investigator identities

Correct Answer: They provide validated, time-stamped data extracts used for analysis and regulatory submission

Q16. Which situation requires expedited SUSAR reporting rather than routine safety reporting?

• A non-serious expected adverse event
• A serious, unexpected adverse reaction suspected to be related to the investigational product
• A pre-existing condition worsening unrelated to drug
• A laboratory value change within protocol-allowed limits

Correct Answer: A serious, unexpected adverse reaction suspected to be related to the investigational product

Q17. During data cleaning prior to lock, an edit check reveals inconsistent units (e.g., mg/dL vs mmol/L) for glucose. What is the correct approach?

• Convert values using a documented conversion factor and document the change source
• Delete values from sites using different units
• Ignore inconsistencies if units were recorded
• Average the values across units without conversion

Correct Answer: Convert values using a documented conversion factor and document the change source

Q18. What role does 21 CFR Part 11 play in the context of electronic database lock?

• Defines lab analytic methods to be used
• Establishes criteria for electronic records and signatures to ensure trustworthiness and reliability of electronic data
• Mandates paper CRFs for all US trials
• Limits the number of database locks allowed per study

Correct Answer: Establishes criteria for electronic records and signatures to ensure trustworthiness and reliability of electronic data

Q19. Which of the following is a best practice for ADR case management before final database lock?

• Leave causality assessments blank until after lock
• Ensure all ADR narratives, causality and outcome are complete and reconciled with CRF and source documents
• Delete mild ADRs to streamline dataset
• Only code ADRs that are serious

Correct Answer: Ensure all ADR narratives, causality and outcome are complete and reconciled with CRF and source documents

Q20. After a certified final database lock, a critical lab value was found to have been incorrectly transcribed. What is the compliant process?

• Edit the database directly and do not document the change
• Initiate a documented post-lock amendment with sponsor approval, re-open the database under change control, make corrections with audit trail, then re-lock
• Delete the subject record to avoid impacting analysis
• Report the error only in a later publication without database correction

Correct Answer: Initiate a documented post-lock amendment with sponsor approval, re-open the database under change control, make corrections with audit trail, then re-lock

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