Safety reporting, EC communications and SAE handling MCQs With Answer

Introduction: This quiz collection focuses on safety reporting, Ethics Committee (EC) communications, and Serious Adverse Event (SAE) handling—core topics for M.Pharm students in Clinical Research (MPP 104T). The questions reinforce practical understanding of SAE definitions, responsibilities of investigators and sponsors, SUSAR identification and timelines, EC interactions, unblinding procedures, causality assessment, periodic safety reporting, and follow-up obligations. Each item is designed to reflect regulatory principles (ICH/GCP) and routine clinical trial practice so you can apply knowledge during protocol conduct, safety monitoring, and regulatory submissions. Use these MCQs to test and strengthen your readiness for safety-related roles in clinical research.

Q1. Which of the following best describes criteria that make an adverse event “serious” under ICH-GCP?

• Any adverse event that causes pain or discomfort of any intensity
• An event that results in death, is life‑threatening, requires hospitalization or prolongation of hospitalization, results in persistent disability/incapacity, causes a congenital anomaly, or is otherwise medically important
• An adverse event of mild intensity that resolves without treatment
• Any laboratory abnormality regardless of clinical consequence

Correct Answer: An event that results in death, is life‑threatening, requires hospitalization or prolongation of hospitalization, results in persistent disability/incapacity, causes a congenital anomaly, or is otherwise medically important

Q2. How is “seriousness” different from “severity” in the context of adverse events?

• Severity refers to regulatory reporting requirements, seriousness refers only to how painful the event is
• Seriousness indicates the outcome or healthcare consequence (e.g., hospitalization), while severity describes the intensity of the event (mild, moderate, severe)
• They are interchangeable terms with identical meaning
• Severity is used only for laboratory abnormalities, seriousness only for clinical events

Correct Answer: Seriousness indicates the outcome or healthcare consequence (e.g., hospitalization), while severity describes the intensity of the event (mild, moderate, severe)

Q3. What is the standard regulatory timeline for initial reporting of a fatal or life‑threatening SUSAR to the competent authority under ICH E2A principles?

• 30 calendar days
• 15 calendar days
• 7 calendar days for initial notification, followed by up to 8 days for a complete report
• No expedited reporting is required for SUSARs

Correct Answer: 7 calendar days for initial notification, followed by up to 8 days for a complete report

Q4. For a non‑fatal SUSAR, what is the generally accepted expedited reporting timeframe to regulators?

• 72 hours
• 15 calendar days
• 60 calendar days
• No reporting required if non‑fatal

Correct Answer: 15 calendar days

Q5. Who bears the primary responsibility for expedited reporting of SUSARs to regulatory authorities and ethics committees?

• The trial participant
• The sponsor
• The clinical trial monitor only
• The independent data monitoring committee (IDMC) exclusively

Correct Answer: The sponsor

Q6. What is the investigator’s immediate reporting obligation when an SAE occurs at the trial site?

• Log it in a personal notebook and report at the end of the study
• Report the SAE promptly to the sponsor and to the Institutional EC as required by site SOPs, typically immediately or within 24 hours for life‑threatening events, with a written follow‑up
• Only report fatal events; non‑fatal events need not be reported
• Report only if the subject or family requests reporting

Correct Answer: Report the SAE promptly to the sponsor and to the Institutional EC as required by site SOPs, typically immediately or within 24 hours for life‑threatening events, with a written follow‑up

Q7. Which of the following best defines a SUSAR?

• An adverse event that is expected and unrelated to the investigational product
• A serious adverse reaction that is suspected to be related to the investigational product and is unexpected in nature or severity compared with the applicable product information
• An administrative error in trial documentation
• A non‑serious event occurring in a healthy volunteer

Correct Answer: A serious adverse reaction that is suspected to be related to the investigational product and is unexpected in nature or severity compared with the applicable product information

Q8. Which events require expedited reporting?

• All adverse events, regardless of seriousness or relatedness
• Only events that are serious, unexpected, and suspected to be related to the investigational product (SUSARs)
• Only minor laboratory abnormalities
• Only events occurring after study completion

Correct Answer: Only events that are serious, unexpected, and suspected to be related to the investigational product (SUSARs)

Q9. Who performs the initial causality assessment of an SAE?

• The clinical trial participant
• The investigator at the trial site assesses causality initially; the sponsor then conducts an independent assessment for reporting
• The Ethics Committee alone
• No causality assessment is needed for SAEs

Correct Answer: The investigator at the trial site assesses causality initially; the sponsor then conducts an independent assessment for reporting

Q10. Under what circumstance is unblinding allowed for a SUSAR?

• Unblinding is never allowed under any circumstance
• Unblinding may be performed when necessary to assess and report a suspected unexpected serious adverse reaction to ensure appropriate medical management and regulatory reporting
• Unblinding should be performed for every non‑serious AE
• Unblinding is performed only after database lock

Correct Answer: Unblinding may be performed when necessary to assess and report a suspected unexpected serious adverse reaction to ensure appropriate medical management and regulatory reporting

Q11. What is the purpose of a Development Safety Update Report (DSUR)?

• To report individual case reports only
• To provide an annual integrated safety review of a medicinal product under clinical development, summarizing worldwide safety information and benefit‑risk
• To replace all expedited SUSAR reporting
• To document study financial expenditures

Correct Answer: To provide an annual integrated safety review of a medicinal product under clinical development, summarizing worldwide safety information and benefit‑risk

Q12. What is the role of a Data and Safety Monitoring Board (DSMB) or independent data monitoring committee (IDMC)?

• To conduct site recruitment and consenting procedures
• To independently review accumulating safety (and sometimes efficacy) data and recommend whether a trial should continue, be modified, or be stopped for safety or benefit reasons
• To handle financial audits of the trial
• To write informed consent forms

Correct Answer: To independently review accumulating safety (and sometimes efficacy) data and recommend whether a trial should continue, be modified, or be stopped for safety or benefit reasons

Q13. How should pregnancy occurring during a clinical trial be handled for reporting purposes?

• Pregnancy is not reportable under any circumstances
• Pregnancy should be notified to the sponsor; while pregnancy itself is not an AE, any adverse pregnancy outcome (e.g., congenital anomaly, fetal death) is reported as an SAE
• Pregnancy should only be recorded in the investigator’s personal notes
• Pregnancy should always lead to immediate trial termination for that participant

Correct Answer: Pregnancy should be notified to the sponsor; while pregnancy itself is not an AE, any adverse pregnancy outcome (e.g., congenital anomaly, fetal death) is reported as an SAE

Q14. What constitutes an “unexpected” adverse reaction when assessing whether an SAE is a SUSAR?

• An event listed in the protocol’s expected adverse events list
• An adverse reaction whose nature or severity is not consistent with the applicable product information (e.g., Investigator’s Brochure or SmPC)
• Any event occurring in more than 10% of subjects
• A laboratory value that is within the normal range

Correct Answer: An adverse reaction whose nature or severity is not consistent with the applicable product information (e.g., Investigator’s Brochure or SmPC)

Q15. What steps should a sponsor take when receiving an SAE report from an investigator?

• Ignore it if the event seems minor
• Perform expedited review, assess causality and expectedness, determine whether it meets criteria for SUSAR reporting, notify regulators and ECs if required, and follow up until resolution
• Only archive the report for annual filing
• Send the report back to the investigator requesting additional signatures only

Correct Answer: Perform expedited review, assess causality and expectedness, determine whether it meets criteria for SUSAR reporting, notify regulators and ECs if required, and follow up until resolution

Q16. What is an appropriate follow‑up action after initial SAE notification?

• No follow‑up is necessary after initial notification
• Collect missing clinical information, update causality/diagnosis, submit follow‑up reports to sponsor/regulators/ECs until a final outcome is available
• Close the case file immediately
• Stop all safety monitoring for the subject

Correct Answer: Collect missing clinical information, update causality/diagnosis, submit follow‑up reports to sponsor/regulators/ECs until a final outcome is available

Q17. Which party typically submits SUSAR reports to the Ethics Committee?

• The trial participant directly
• The sponsor submits SUSAR reports to the EC, often with copies to investigators and regulators as required
• The EC writes its own SUSAR reports without input
• The DSMB is solely responsible for EC submission

Correct Answer: The sponsor submits SUSAR reports to the EC, often with copies to investigators and regulators as required

Q18. What documentation should the investigator maintain at site for each SAE?

• Only an email to the sponsor is sufficient; no local records required
• Complete source documents, medical records, signed SAE form, correspondence with sponsor/EC/regulatory authorities, and follow‑up data
• Only a single line entry in the pharmacy log
• Only financial records related to subject compensation

Correct Answer: Complete source documents, medical records, signed SAE form, correspondence with sponsor/EC/regulatory authorities, and follow‑up data

Q19. When can an Ethics Committee be bypassed before implementing a safety‑related protocol amendment?

• Never; the EC must always approve before any change
• In an urgent safety measure needed to eliminate an immediate hazard to subjects, the measure may be implemented immediately and the EC informed promptly afterwards
• Only when the sponsor requests it
• When the amendment reduces monitoring requirements

Correct Answer: In an urgent safety measure needed to eliminate an immediate hazard to subjects, the measure may be implemented immediately and the EC informed promptly afterwards

Q20. What is a “safety signal” in pharmacovigilance?

• A confirmed causal relationship established in a randomized trial
• Information that arises from one or multiple sources suggesting a new potentially causal association or a new aspect of a known association between an intervention and an adverse event that warrants further investigation
• A promotional claim about product safety
• An adverse event with zero background incidence

Correct Answer: Information that arises from one or multiple sources suggesting a new potentially causal association or a new aspect of a known association between an intervention and an adverse event that warrants further investigation

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