Safety monitoring in clinical trials: ADR detection and reporting MCQs With Answer

Introduction: Safety monitoring in clinical trials: ADR detection and reporting MCQs With Answer is a focused resource designed for M.Pharm students preparing for careers in clinical research and pharmacovigilance. This set of questions emphasizes detection, assessment, documentation, and regulatory reporting of adverse drug reactions (ADRs) that occur during clinical trials. Topics include spontaneous reporting, SAE and SUSAR timelines, causality assessment methods, signal detection techniques, MedDRA coding, responsibilities of investigators and sponsors, and risk minimization measures. These MCQs are crafted to deepen conceptual understanding, improve practical decision-making, and reinforce regulatory expectations encountered in real-world pharmacovigilance practice.

Q1. What is the primary purpose of safety monitoring in clinical trials?

• To maximize trial enrollment
• To detect, assess and minimize risks to participants
• To accelerate study timelines
• To replace preclinical safety testing

Correct Answer: To detect, assess and minimize risks to participants

Q2. Which of the following best defines a Serious Adverse Event (SAE) in a clinical trial?

• An adverse event that resolves within 24 hours
• An adverse event that is life-threatening, requires hospitalization, causes persistent disability, or is fatal
• An adverse event that is expected and non-clinically significant
• A non-serious, transient side effect like mild headache

Correct Answer: An adverse event that is life-threatening, requires hospitalization, causes persistent disability, or is fatal

Q3. SUSAR stands for which of the following?

• Serious Unexpected Suspected Adverse Reaction
• Safe Use Study Adverse Report
• Special Use Spontaneous Adverse Reaction
• Sponsor Unblinding Safety Assessment Report

Correct Answer: Serious Unexpected Suspected Adverse Reaction

Q4. According to ICH guidelines, what is the usual timeline for reporting a fatal or life-threatening SUSAR to regulatory authorities?

• Within 24 hours of discovery
• Within 7 calendar days followed by a full report within 8 additional days
• Within 30 days of the event
• Only in the annual safety report

Correct Answer: Within 7 calendar days followed by a full report within 8 additional days

Q5. Which causality assessment tool is commonly used in clinical practice for structured evaluation of ADR likelihood?

• Hodge Scale
• Naranjo Algorithm
• Cochrane Checklist
• Kaplan-Meier Test

Correct Answer: Naranjo Algorithm

Q6. In clinical trials, who is primarily responsible for initially reporting an SAE to the sponsor?

• The trial monitor (CRA)
• The investigator at the site
• The contract research organization (CRO) only
• The study participant

Correct Answer: The investigator at the site

Q7. What is a key difference between safety monitoring in clinical trials and post-marketing pharmacovigilance?

• Clinical trials rely only on spontaneous reports, post-marketing uses active surveillance
• Clinical trials have defined protocols and monitoring; post-marketing typically involves broader population exposure and spontaneous reporting
• There are no regulatory requirements for trial safety monitoring
• Post-marketing safety monitoring does not require coding of events

Correct Answer: Clinical trials have defined protocols and monitoring; post-marketing typically involves broader population exposure and spontaneous reporting

Q8. Which classification dictionary is standard for coding adverse events in clinical trials?

• WHO-ART
• MedDRA
• ICD-10 only
• DSM-5

Correct Answer: MedDRA

Q9. Disproportionality analysis in signal detection commonly uses which metric?

• Relative Risk Reduction (RRR)
• Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)
• Number Needed to Harm (NNH)
• Kaplan-Meier survival estimate

Correct Answer: Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)

Q10. Which document outlines the sponsor’s plan to identify, characterize and minimize risks related to a medicinal product?

• Investigator Brochure (IB)
• Risk Management Plan (RMP)
• Informed Consent Form (ICF)
• Trial Master File (TMF)

Correct Answer: Risk Management Plan (RMP)

Q11. What is the primary role of a Data Safety Monitoring Board (DSMB) in a clinical trial?

• To recruit participants
• To independently review accumulating safety (and sometimes efficacy) data and recommend continuation, modification, or stopping of the trial
• To manage trial finances
• To write the final study report

Correct Answer: To independently review accumulating safety (and sometimes efficacy) data and recommend continuation, modification, or stopping of the trial

Q12. Which regulatory guidance describes expedited reporting of SUSARs in clinical trials?

• ICH E6(R2)
• ICH E2A
• ICH Q9
• GCP does not cover SUSAR reporting

Correct Answer: ICH E2A

Q13. In an open-label trial an investigator observes an unexpected severe reaction. This should be reported as:

• A non-serious adverse event in the next visit
• An SAE report immediately to the sponsor, and if unexpected and related, as a SUSAR to regulators
• Only in the final study publication
• To the ethics committee annually

Correct Answer: An SAE report immediately to the sponsor, and if unexpected and related, as a SUSAR to regulators

Q14. Which of the following is a common cause of under-reporting of ADRs in clinical trials?

• Overly sensitive safety surveillance
• Perception that common events are unrelated to the investigational product
• Mandatory immediate reporting systems
• High awareness and training among investigators

Correct Answer: Perception that common events are unrelated to the investigational product

Q15. What is the primary function of an Investigator Brochure (IB) in safety monitoring?

• To list eligible study sites
• To provide investigators with comprehensive and current safety and efficacy information about the investigational product
• To replace the informed consent process
• To record participant payment details

Correct Answer: To provide investigators with comprehensive and current safety and efficacy information about the investigational product

Q16. Which element is essential in an SAE report submitted by an investigator?

• Only the participant’s initials without event details
• Detailed description of the event, onset date, outcome, causality assessment, and treatment given
• Only a copy of the informed consent form
• Only laboratory data without clinical context

Correct Answer: Detailed description of the event, onset date, outcome, causality assessment, and treatment given

Q17. When a pregnancy occurs in a female trial participant exposed to an investigational drug, the recommended action is:

• Ignore unless the infant shows problems
• Report the pregnancy and follow maternal and fetal outcomes as per protocol, with expedited reporting if there are serious fetal outcomes
• Unblind all trial participants immediately
• Terminate the trial site

Correct Answer: Report the pregnancy and follow maternal and fetal outcomes as per protocol, with expedited reporting if there are serious fetal outcomes

Q18. Which of the following best describes a safety signal?

• A single trivial adverse event
• Information that suggests a new or known causal association between an intervention and an adverse event that is worth further investigation
• A confirmed causal relationship proven beyond doubt
• A marketing claim about safety

Correct Answer: Information that suggests a new or known causal association between an intervention and an adverse event that is worth further investigation

Q19. In the context of clinical trial reporting, what is an expedited report?

• A routine monthly summary of all adverse events
• A fast-tracked notification to authorities describing a serious, unexpected, and probably related adverse reaction
• A late annual analysis of safety data
• A non-urgent communication to participants

Correct Answer: A fast-tracked notification to authorities describing a serious, unexpected, and probably related adverse reaction

Q20. Which of the following is a key responsibility of the sponsor regarding safety monitoring?

• Designing the clinical protocol without safety oversight
• Ensuring timely collection, evaluation, reporting of safety data and submission of Periodic Safety Update Reports (PSURs) as required
• Recruiting investigators only
• Withholding safety findings until study completion

Correct Answer: Ensuring timely collection, evaluation, reporting of safety data and submission of Periodic Safety Update Reports (PSURs) as required

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