Site initiation, monitoring visits and source document review MCQs With Answer

Introduction: Site initiation, monitoring visits and source document review are critical components of clinical trial conduct, ensuring participant safety, data integrity and regulatory compliance. This quiz set is designed for M.Pharm students to deepen understanding of responsibilities during site initiation visits (SIV), routine and close-out monitoring, and meticulous source document management. Questions focus on the objectives and typical activities of visits, monitoring strategies (including risk-based and remote monitoring), essential documents per ICH-GCP, source data verification (SDV), common findings and corrective actions. These MCQs will help students apply guidelines to practical scenarios encountered in clinical research operations, preparing them for roles in study coordination, monitoring and quality assurance.

Q1. What is the primary objective of a Site Initiation Visit (SIV)?

• To close the study at the site
• To initiate subject recruitment without reviewing documentation
• To ensure the site staff understand the protocol, safety reporting, investigational product handling and study procedures
• To perform final source data verification for all subjects

Correct Answer: To ensure the site staff understand the protocol, safety reporting, investigational product handling and study procedures

Q2. Which document is considered a primary source for confirming a subject’s eligibility criteria?

• Study brochure
• Signed informed consent form stored in the investigator site file
• Original hospital medical records and lab reports
• Data entered into the clinical database only

Correct Answer: Original hospital medical records and lab reports

Q3. During monitoring visits, “SDV” most accurately refers to:

• Standardized Drug Validation
• Source Data Verification — comparing data entered in CRFs/EDC with original source documents
• Site Data Validation — validating eCRF setup
• Statistical Data Visualization

Correct Answer: Source Data Verification — comparing data entered in CRFs/EDC with original source documents

Q4. Which of the following is an example of a critical finding often identified during source document review?

• Minor typographical errors in site contact list
• Missing documented evidence of informed consent prior to study procedures
• Non-legible handwritten notes in a personal notebook unrelated to the study
• Site parking directions omitted from the file

Correct Answer: Missing documented evidence of informed consent prior to study procedures

Q5. Which principle best describes the ALCOA attributes expected of source documents?

• Accurate, Legible, Contemporaneous, Original, Attributable
• Accessible, Legal, Controlled, Organized, Archived
• Analytical, Logical, Concise, Objective, Accountable
• Available, Linked, Confirmed, Observed, Authorized

Correct Answer: Accurate, Legible, Contemporaneous, Original, Attributable

Q6. What is an appropriate immediate action by a monitor when a serious adverse event (SAE) is found to be unreported in the source documents?

• Ignore it if the subject recovered
• Document the finding in the monitoring report and require the site to report the SAE to the sponsor and update records immediately
• Delete the entry to avoid escalation
• Wait until the next monitoring visit to mention it casually

Correct Answer: Document the finding in the monitoring report and require the site to report the SAE to the sponsor and update records immediately

Q7. Risk-Based Monitoring (RBM) typically reduces which activity compared with traditional monitoring?

• Remote data review
• Frequency of on-site full source data verification for low-risk data points
• Use of central statistical monitoring
• Regulatory submissions

Correct Answer: Frequency of on-site full source data verification for low-risk data points

Q8. Which item is part of the essential documents to be reviewed during a Site Initiation Visit according to ICH-GCP?

• Investigator’s delegation log and training records
• Invoices for catering services
• Personal schedules of site staff
• Internal personal email correspondence

Correct Answer: Investigator’s delegation log and training records

Q9. When performing source document review, how should a monitor handle a discrepancy between a lab report and data entered in the eCRF?

• Assume the eCRF is correct and ignore the lab report
• Raise a query to the site requesting clarification and documentation of any legitimate correction, with source documentation evidence
• Change the lab report to match the eCRF
• Delay action until study close-out

Correct Answer: Raise a query to the site requesting clarification and documentation of any legitimate correction, with source documentation evidence

Q10. Which monitoring visit is primarily focused on verifying that all data queries are resolved, investigational product is accounted for and study close-out activities are complete?

• Pre-study visit
• Interim monitoring visit
• Close-out visit
• Site initiation visit

Correct Answer: Close-out visit

Q11. In the context of monitoring reports, which element is essential to include after each on-site visit?

• Personal opinions about the PI’s management style
• Detailed list of findings, action items, required timelines and sponsor contact information
• Financial details of the site’s other studies
• Local weather report on the day of the visit

Correct Answer: Detailed list of findings, action items, required timelines and sponsor contact information

Q12. Which best describes remote monitoring activities?

• Only phone calls to remind site staff of visits
• Centralized review of electronic data, query management, and limited remote SDV using secure access where permitted
• Replacing all on-site visits with automated emails
• Reviewing non-study-related personal files

Correct Answer: Centralized review of electronic data, query management, and limited remote SDV using secure access where permitted

Q13. Which is an appropriate metric for determining monitoring frequency at a site?

• Site location zip code
• Study risk profile, enrollment rate, site performance and prior monitoring findings
• Popularity of the investigator in social media
• Time since the PI obtained medical degree regardless of experience

Correct Answer: Study risk profile, enrollment rate, site performance and prior monitoring findings

Q14. A monitor discovers unsigned source entries and missing dates in the patient medical record. What is the correct remediation?

• Tell the site to destroy the records
• Request that the investigator or authorized staff add dated signatures or initials and, where permitted, documented explanations for late entries per ALCOA‑C principles
• Ignore because signatures are not important
• Sign on behalf of the investigator

Correct Answer: Request that the investigator or authorized staff add dated signatures or initials and, where permitted, documented explanations for late entries per ALCOA‑C principles

Q15. Which action is within the monitor’s responsibility during a routine monitoring visit?

• Authorizing protocol deviations on behalf of the sponsor
• Reviewing source documents, verifying informed consent, checking IP accountability and documenting findings
• Discharging site staff
• Conducting independent clinical care of subjects

Correct Answer: Reviewing source documents, verifying informed consent, checking IP accountability and documenting findings

Q16. What is the preferred way to document a correction in source documents?

• Using white-out to hide the original text
• Single line through original entry, date, time, reason if required, and sign/initial by person making the correction
• Erasing original text and rewriting
• Creating a new unrelated document

Correct Answer: Single line through original entry, date, time, reason if required, and sign/initial by person making the correction

Q17. Which factor most likely triggers a targeted monitoring visit?

• Complete absence of queries
• Identification of repeated protocol deviations or potential data integrity issues from central monitoring
• Site hosting a social event
• Large number of staff vacations

Correct Answer: Identification of repeated protocol deviations or potential data integrity issues from central monitoring

Q18. Which element should NOT be altered when comparing source documents to eCRF entries during SDV?

• Check that eCRF matches the original source; do not change source to match eCRF without documented reason
• Accept any eCRF entry as final without verification
• Modify the investigator signature to match the eCRF
• Replace laboratory reports with summaries

Correct Answer: Check that eCRF matches the original source; do not change source to match eCRF without documented reason

Q19. Which of the following is a common monitoring finding related to investigational product (IP) management?

• IP stored at recommended temperature with complete accountability logs
• Discrepancies between IP shipment records and site accountability log
• Excessive labeling accuracy
• Frequent monitoring visits improve IP management so no issues occur

Correct Answer: Discrepancies between IP shipment records and site accountability log

Q20. When a monitor identifies a critical deficiency at a site, what is the expected next step from the sponsor or monitor?

• Ignore and continue routine operations
• Issue a corrective and preventive action (CAPA) plan with timelines, monitor remediation progress and escalate to QA if unresolved
• Terminate the monitor’s contract
• Delay any action until study completion

Correct Answer: Issue a corrective and preventive action (CAPA) plan with timelines, monitor remediation progress and escalate to QA if unresolved

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