Clinical trial monitoring and site management MCQs With Answer

Introduction:

This collection of Clinical Trial Monitoring and Site Management MCQs with answers is created specifically for M.Pharm students preparing for advanced examinations and practical roles in clinical research. Questions focus on monitoring strategies, site selection and initiation, regulatory compliance, source data verification, risk-based monitoring, investigator oversight, IMP handling, and documentation standards. Each item tests conceptual understanding and applied decision-making used by CRAs, study coordinators, and data managers. Answers are provided to reinforce learning and highlight best practices for quality assurance, inspection readiness, and patient safety. Use these questions to evaluate your readiness for real-world monitoring responsibilities and postgraduate-level assessments.

Q1. What is the primary objective of on-site clinical trial monitoring?

• To recruit the maximum number of subjects
• To ensure the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements
• To perform laboratory analyses for the sponsor
• To prepare the final clinical study report

Correct Answer: To ensure the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements

Q2. Which activity is NOT typically the responsibility of a Clinical Research Associate (CRA) during a monitoring visit?

• Source data verification (SDV)
• Training site staff on protocol procedures
• Performing central laboratory assays
• Reviewing informed consent documentation

Correct Answer: Performing central laboratory assays

Q3. Risk-Based Monitoring (RBM) primarily reduces monitoring efforts by:

• Eliminating all on-site monitoring
• Applying focused monitoring activities based on critical data and processes that could impact subject safety or data integrity
• Increasing source data verification to 100% for all subjects
• Outsourcing monitoring to third-party CROs exclusively

Correct Answer: Applying focused monitoring activities based on critical data and processes that could impact subject safety or data integrity

Q4. Which document must always be present and up-to-date at the site to demonstrate delegation of study tasks?

• Investigator’s Brochure
• Sponsor’s monitoring plan
• Delegation of Authority Log (or Staff Signature and Delegation Log)
• Data Management Plan

Correct Answer: Delegation of Authority Log (or Staff Signature and Delegation Log)

Q5. During monitoring, a CRA finds several protocol deviations. The best initial action is to:

• Terminate the investigator’s participation immediately
• Document deviations, assess impact on subject safety/data integrity, discuss corrective actions with site, and escalate if necessary
• Ignore minor deviations and only report major ones annually
• Rewrite the protocol to accommodate deviations

Correct Answer: Document deviations, assess impact on subject safety/data integrity, discuss corrective actions with site, and escalate if necessary

Q6. What is source data verification (SDV)?

• Comparing data recorded in the case report form (CRF) with original source documents to confirm accuracy
• Verifying that the site has the required monitoring equipment
• Checking the sponsor’s financial records
• Auditing the CRO’s internal processes

Correct Answer: Comparing data recorded in the case report form (CRF) with original source documents to confirm accuracy

Q7. Which of the following is a key component of a monitoring visit report?

• Details of the CRA’s personal schedule for the week
• Summary of findings, action items, open/closed queries, and timelines for corrective actions
• Manufacturer’s batch release certificate
• Final statistical analysis plan

Correct Answer: Summary of findings, action items, open/closed queries, and timelines for corrective actions

Q8. For an expedited Serious Adverse Event (SAE) reporting, the investigator is typically required to notify the sponsor within:

• 24 hours for all non-serious adverse events
• Immediate or within 24 hours for life-threatening SAEs, usually within 24 hours of awareness
• 30 days after the event
• Only at the end of the study

Correct Answer: Immediate or within 24 hours for life-threatening SAEs, usually within 24 hours of awareness

Q9. What is the main purpose of a Site Initiation Visit (SIV)?

• To close out the site after the study
• To ensure the site is ready to start the study, including training staff, confirming supplies, and reviewing essential documents
• To monitor the final data analysis
• To recruit patients on behalf of the investigator

Correct Answer: To ensure the site is ready to start the study, including training staff, confirming supplies, and reviewing essential documents

Q10. Which metric is most relevant for assessing site performance in enrollment?

• Number of monitoring visits conducted
• Screening-to-randomization ratio or enrollment rate per site
• Number of protocol amendments
• Number of SOPs at the site

Correct Answer: Screening-to-randomization ratio or enrollment rate per site

Q11. Investigator qualification files should contain which of the following?

• Patient medical records for all participants
• Curriculum vitae (CV), medical license, GCP training certificates, and delegation log
• Sponsor’s internal QA audit reports
• All CRFs from previous studies

Correct Answer: Curriculum vitae (CV), medical license, GCP training certificates, and delegation log

Q12. Which action describes a proper process for handling Investigational Medicinal Product (IMP) temperature excursions?

• Discard product immediately without documentation
• Document the excursion, quarantine affected IMP, assess impact, notify sponsor, and implement corrective and preventive actions (CAPA)
• Return IMP to general pharmacy stock
• Ignore minor excursions if labels are intact

Correct Answer: Document the excursion, quarantine affected IMP, assess impact, notify sponsor, and implement corrective and preventive actions (CAPA)

Q13. Remote monitoring differs from on-site monitoring in that it primarily:

• Relies on remote access to electronic source documents and eCRFs to perform centralized reviews and reduce SDV on-site
• Replaces all regulatory inspections
• Requires physical review of source documents at the sponsor office
• Eliminates the need for any investigator oversight

Correct Answer: Relies on remote access to electronic source documents and eCRFs to perform centralized reviews and reduce SDV on-site

Q14. During monitor selection of critical data for RBM, which category is most often prioritized?

• Administrative contact information
• Data related to primary efficacy endpoints, safety (SAEs), informed consent, and eligibility
• Site parking details
• Financial invoices unrelated to subject safety

Correct Answer: Data related to primary efficacy endpoints, safety (SAEs), informed consent, and eligibility

Q15. What is a corrective and preventive action (CAPA) plan in the context of site management?

• A financial penalty applied to sites for slow enrollment
• A formal plan to correct identified issues and to prevent recurrence, including root cause analysis and timelines
• A schedule of monitoring visits only
• A recruitment advertisement template

Correct Answer: A formal plan to correct identified issues and to prevent recurrence, including root cause analysis and timelines

Q16. Which of the following best describes inadequate source documentation?

• Comprehensive, contemporaneous notes with subject identifiers removed
• Incomplete, inconsistent, or missing entries that prevent reconstruction of study conduct and subject outcomes
• Copies of CRFs stored securely
• Detailed lab reports linked to subject IDs

Correct Answer: Incomplete, inconsistent, or missing entries that prevent reconstruction of study conduct and subject outcomes

Q17. What is the chief purpose of the Monitoring Plan?

• To describe the statistical methods for the study
• To define monitoring strategy, visit frequency, responsibilities, critical data to be reviewed, and escalation pathways
• To register the trial with regulatory authorities
• To provide the budget for the study

Correct Answer: To define monitoring strategy, visit frequency, responsibilities, critical data to be reviewed, and escalation pathways

Q18. Which is the appropriate timeframe for retaining essential clinical trial documents at the site following study completion?

• One month after last subject visit
• As specified by the protocol, sponsor and local regulations — commonly at least 2 years after last approval of marketing application or longer per local law
• Until the next monitoring visit
• No retention is required

Correct Answer: As specified by the protocol, sponsor and local regulations — commonly at least 2 years after last approval of marketing application or longer per local law

Q19. Which indicator most directly signals potential issues with data quality at a site?

• High rate of query resolution within 24 hours
• Frequent unresolved CRF queries, inconsistent data entries, and repeated protocol deviations
• Comprehensive training records
• Strong enrollment numbers without any queries

Correct Answer: Frequent unresolved CRF queries, inconsistent data entries, and repeated protocol deviations

Q20. During a close-out visit, which activity is essential to ensure regulatory compliance?

• Ensure all source documents, signed and dated consent forms, final CRFs, IMP accountability reconciliation, and regulatory files are complete and archived
• Only collect leftover IMP without documentation
• Uninstall all electronic systems at the site
• Terminate all site staff without notice

Correct Answer: Ensure all source documents, signed and dated consent forms, final CRFs, IMP accountability reconciliation, and regulatory files are complete and archived

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