Pharmacovigilance in clinical trials MCQs With Answer

Pharmacovigilance in Clinical Trials MCQs With Answer provides M. Pharm students with a focused and practical assessment tool on safety surveillance during drug development. This blog covers core concepts and regulatory expectations under ICH and major agencies (US FDA, EU) relevant to clinical trial safety management. You will practice the distinctions between AE/SAE, causality and expectedness, SUSAR reporting, IB/RSI, DSUR preparation, MedDRA coding, and the roles of investigators, sponsors, ECs/IRBs, and DSMBs. Questions emphasise timelines, documentation standards, unblinding principles, signal detection, and aggregate reporting. These MCQs are designed to deepen understanding for Regulatory Affairs (MPH 104T), helping you interpret guidance such as ICH E2A/E2F and apply pharmacovigilance principles confidently in real-world clinical research settings.

Q1. The primary objective of pharmacovigilance in clinical trials is to

• Demonstrate statistical superiority of the investigational product
• Detect, assess, understand, and prevent adverse effects and other safety issues
• Maximize recruitment speed and site activation
• Ensure exclusive use of placebo in control arms

Correct Answer: Detect, assess, understand, and prevent adverse effects and other safety issues

Q2. Which statement best differentiates severity from seriousness in adverse event evaluation?

• Severity relates to medical importance; seriousness relates to intensity
• Severity refers to intensity; seriousness relates to outcome-based regulatory criteria
• Severity and seriousness are interchangeable terms
• Seriousness is graded as mild, moderate, severe

Correct Answer: Severity refers to intensity; seriousness relates to outcome-based regulatory criteria

Q3. Which of the following qualifies as a Serious Adverse Event (SAE)?

• Mild, transient headache that resolves without treatment
• Laboratory value slightly outside normal range with no clinical significance
• Event requiring inpatient hospitalization or prolongation of existing hospitalization
• Expected injection site pain

Correct Answer: Event requiring inpatient hospitalization or prolongation of existing hospitalization

Q4. A SUSAR in clinical trials is defined as a

• Suspected Unexpected Serious Adverse Reaction
• Serious Unexpected Significant Adverse Risk
• Severe Unrelated Severe Adverse Reaction
• Serious Unanticipated Study Adverse Result

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q5. Expectedness of an adverse reaction during a clinical trial is determined with reference to the

• Protocol synopsis
• Informed consent form
• Reference Safety Information section of the Investigator’s Brochure
• Monitoring plan

Correct Answer: Reference Safety Information section of the Investigator’s Brochure

Q6. The sponsor should report a fatal or life-threatening SUSAR to the regulatory authority

• Within 7 calendar days (with up to 8 additional days for follow-up)
• Within 30 calendar days
• Within 3 working days
• At the next annual report

Correct Answer: Within 7 calendar days (with up to 8 additional days for follow-up)

Q7. For a non-fatal, non–life-threatening SUSAR, the expedited reporting timeline is generally

• Within 24 hours
• Within 72 hours
• Within 15 calendar days
• Within 60 calendar days

Correct Answer: Within 15 calendar days

Q8. Which of the following best describes the role of the Data Safety Monitoring Board (DSMB) in clinical trials?

• Executes site monitoring visits and SDV activities
• Oversees patient recruitment and randomization
• Independently reviews unblinded safety/efficacy data to recommend trial continuation, modification, or termination
• Authors the clinical study report

Correct Answer: Independently reviews unblinded safety/efficacy data to recommend trial continuation, modification, or termination

Q9. The investigator’s responsibility for reporting SAEs to the sponsor is best captured by which statement?

• Report SAEs within 24 hours or as specified in the protocol to the sponsor
• Report SAEs only at the end of the study
• Report SAEs to the sponsor only if related
• Report SAEs solely to the ethics committee

Correct Answer: Report SAEs within 24 hours or as specified in the protocol to the sponsor

Q10. Under IND safety reporting, sponsors must notify regulators and all investigators of which type of events?

• Any adverse event of mild intensity
• Serious and unexpected suspected adverse reactions and other significant safety findings
• Expected adverse events listed in the protocol
• All protocol deviations

Correct Answer: Serious and unexpected suspected adverse reactions and other significant safety findings

Q11. The standard hierarchy in MedDRA coding from highest to lowest level is

• PT → LLT → SOC → HLT → HLGT
• SOC → HLGT → HLT → PT → LLT
• HLT → HLGT → SOC → PT → LLT
• SOC → HLT → HLGT → PT → LLT

Correct Answer: SOC → HLGT → HLT → PT → LLT

Q12. The CIOMS I form is primarily used for

• Randomization list generation
• Expedited reporting of individual case safety reports (ICSRs)
• Electronic submission of DSUR
• Site feasibility assessment

Correct Answer: Expedited reporting of individual case safety reports (ICSRs)

Q13. When a serious event occurs in a blinded trial and expedited reporting is required, the sponsor should

• Never unblind under any circumstances
• Unblind only the individual case if necessary for causality/expectedness, maintaining overall study blinding
• Unblind all subjects in the study
• Ask the investigator to guess treatment without unblinding

Correct Answer: Unblind only the individual case if necessary for causality/expectedness, maintaining overall study blinding

Q14. Which best describes an Important Medical Event (IME) in seriousness assessment?

• An event that is always non-serious
• An event that may be serious based on medical judgment even without hospitalization
• An event that is only serious if life-threatening
• An event limited to laboratory abnormalities

Correct Answer: An event that may be serious based on medical judgment even without hospitalization

Q15. The Development Safety Update Report (DSUR) is typically submitted

• Weekly
• Quarterly
• Annually for the entire development program
• Only after marketing authorization

Correct Answer: Annually for the entire development program

Q16. The Development International Birth Date (DIBD) used for DSUR scheduling is defined as

• The date of first subject first visit in any study
• The date of first marketing authorization
• The date of the sponsor’s first regulatory authorization to conduct a clinical trial anywhere globally
• The date the Investigator’s Brochure is first issued

Correct Answer: The date of the sponsor’s first regulatory authorization to conduct a clinical trial anywhere globally

Q17. Which causality assessment approaches are most commonly referenced in clinical safety evaluation?

• Naranjo and WHO-UMC methods
• Cochrane and PRISMA methods
• CONSORT and STROBE methods
• GCP and GMP methods

Correct Answer: Naranjo and WHO-UMC methods

Q18. Regarding pregnancy in a clinical trial, which statement is most accurate?

• Pregnancy is an SAE in all cases
• Pregnancy is not an AE by itself but must be reported to the sponsor and followed to outcome; congenital anomaly is an SAE
• Pregnancy never needs to be reported
• Only twin pregnancies are reportable

Correct Answer: Pregnancy is not an AE by itself but must be reported to the sponsor and followed to outcome; congenital anomaly is an SAE

Q19. Which of the following BEST describes the content focus of a DSUR?

• Only site performance metrics and enrollment rates
• Cumulative safety data, signal evaluation, benefit–risk assessment, and proposed changes to the IB/RSI
• Exclusive listing of non-serious AEs from a single study
• Manufacturing process validation reports

Correct Answer: Cumulative safety data, signal evaluation, benefit–risk assessment, and proposed changes to the IB/RSI

Q20. Which practice supports proactive signal detection in a clinical development program?

• Reviewing only individual narratives without aggregation
• Periodic aggregate review of coded AEs/SAEs across studies using MedDRA, SMQs, and trend analyses
• Assessing safety only after study completion
• Ignoring external data from related compounds or class effects

Correct Answer: Periodic aggregate review of coded AEs/SAEs across studies using MedDRA, SMQs, and trend analyses

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