Post-approval expedited reporting procedures MCQs With Answer

Post-approval expedited reporting procedures MCQs With Answer — Introduction

Post-approval expedited reporting procedures describe the fast-track processes that sponsors, investigators, and marketing authorization holders use to report serious and unexpected adverse events after a drug or device is authorized. For B. Pharm students, understanding expedited reporting is vital for pharmacovigilance, regulatory compliance, and patient safety. Key topics include definitions of SUSARs, 7‑day and 15‑day reporting timelines, causality and expectedness assessment, report content, electronic transmission standards (ICH E2B/R3, EudraVigilance), sponsor and investigator roles, and follow-up reports. This focused overview will prepare you for practical reporting tasks and regulatory inspections. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of post-approval expedited reporting?

• To file marketing materials for a product
• To rapidly notify regulators and stakeholders about serious unexpected adverse events after approval
• To delay reporting until periodic aggregate reviews
• To replace routine pharmacovigilance activities

Correct Answer: To rapidly notify regulators and stakeholders about serious unexpected adverse events after approval

Q2. Which of the following best defines a SUSAR?

• A serious, expected adverse reaction with clear causality
• A suspected unexpected serious adverse reaction
• An adverse event occurring only during preclinical studies
• A non-serious adverse event reported in routine periodic reports

Correct Answer: A suspected unexpected serious adverse reaction

Q3. For a life-threatening suspected adverse reaction in a clinical trial under FDA IND rules, the sponsor must report to FDA within:

• 30 calendar days
• 15 calendar days
• 7 calendar days
• 72 hours

Correct Answer: 7 calendar days

Q4. Under EU clinical trial rules, the initial reporting timeframe for a fatal or life‑threatening SUSAR is:

• 30 days
• 15 days
• 7 days
• 3 days

Correct Answer: 7 days

Q5. Which element is essential in an expedited safety report?

• Full preclinical study reports
• Complete marketing plan
• Patient identifier, event description, seriousness, causality assessment, and expectedness
• Only aggregate safety statistics

Correct Answer: Patient identifier, event description, seriousness, causality assessment, and expectedness

Q6. “Expectedness” in expedited reporting refers to:

• Whether the event was predictable based on the known safety profile
• Whether the event occurred in a predictable patient demographic
• Whether the sponsor expected the marketing approval
• Whether the investigator expected the trial outcomes

Correct Answer: Whether the event was predictable based on the known safety profile

Q7. Which regulatory guidance describes clinical safety data management and expedited reporting standards internationally?

• ICH E2A/E2B
• Good Manufacturing Practice (GMP)
• ICH Q10
• ISO 9001

Correct Answer: ICH E2A/E2B

Q8. In marketed product pharmacovigilance, when is a 15‑day alert report typically required?

• For non-serious expected events only
• For serious, unexpected adverse events suggesting a causal relationship
• Only for administrative changes to the label
• For every adverse event reported by a consumer

Correct Answer: For serious, unexpected adverse events suggesting a causal relationship

Q9. Who is primarily responsible for submitting expedited safety reports to regulatory authorities for a clinical trial?

• The study participants
• The contract research organization (CRO) or sponsor
• The investigational site janitor
• The marketing department only

Correct Answer: The contract research organization (CRO) or sponsor

Q10. Which of the following is NOT usually a trigger for expedited reporting?

• Death related to the investigational product
• Unexpected serious adverse reaction
• Label change due to efficacy improvements
• Life‑threatening suspected reaction

Correct Answer: Label change due to efficacy improvements

Q11. Electronic transmission standard commonly used for individual case safety reports is:

• PDF-only submission
• ICH E2B(R3)
• Plain ASCII email only
• Paper CIOMS only

Correct Answer: ICH E2B(R3)

Q12. Which body receives expedited SUSAR reports for clinical trials in the EU?

• Local retail pharmacies
• EudraVigilance (and national competent authorities and ethics committees)
• Only the sponsor’s legal department
• The World Health Organization exclusively

Correct Answer: EudraVigilance (and national competent authorities and ethics committees)

Q13. Causality assessment in an expedited report means determining:

• Whether an adverse event is unrelated to the investigational product only
• Whether there is a reasonable possibility the product caused the event
• Only the statistical significance of the event
• How costly the event will be for the sponsor

Correct Answer: Whether there is a reasonable possibility the product caused the event

Q14. A follow-up expedited report is required when:

• No new information is available
• Additional relevant clinical or laboratory information becomes available after the initial report
• The study is closed
• The product receives additional marketing approval

Correct Answer: Additional relevant clinical or laboratory information becomes available after the initial report

Q15. Which report summarizes safety information annually for an investigational product?

• 15-day expedited report
• Development Safety Update Report (DSUR)
• CIOMS-I
• Daily safety alert

Correct Answer: Development Safety Update Report (DSUR)

Q16. Which of the following is a criterion for a serious adverse event (SAE)?

• Mild transient headache only
• Requires hospitalization or prolongation of hospitalization
• Causes happiness
• Occurs only in preclinical animals

Correct Answer: Requires hospitalization or prolongation of hospitalization

Q17. When an expedited report is submitted, who else typically should the sponsor notify besides regulators?

• Only the stockholders
• Investigators and Institutional Review Boards (IRBs)/Ethics Committees
• The pharmaceutical sales team only
• No one else is required

Correct Answer: Investigators and Institutional Review Boards (IRBs)/Ethics Committees

Q18. Which document defines expectedness of adverse events for marketed products?

• Investigator’s brochure or product label (SmPC)
• Company press release
• Patient’s grocery list
• Investigator training log only

Correct Answer: Investigator’s brochure or product label (SmPC)

Q19. In the FDA system, an IND safety report must be submitted when an event is:

• Serious, unexpected, and reasonably associated with the investigational drug
• Non-serious and expected
• Only observed in animals
• Part of routine manufacturing documentation

Correct Answer: Serious, unexpected, and reasonably associated with the investigational drug

Q20. CIOMS forms are primarily used for:

• Marketing planning
• Standardized narrative case reports for adverse events
• Calculating drug prices
• Employee performance reviews

Correct Answer: Standardized narrative case reports for adverse events

Q21. Which item is NOT typically included in an expedited safety narrative?

• Detailed patient history and event chronology
• Relevant concomitant medications and lab results
• Investigator’s opinion on causality
• Commercial sales forecasts

Correct Answer: Commercial sales forecasts

Q22. Signal detection in pharmacovigilance aims to:

• Identify potential new safety issues from aggregated data
• Promote advertising campaigns
• Reduce clinical monitoring visits
• Improve manufacturing yield

Correct Answer: Identify potential new safety issues from aggregated data

Q23. Which is a common reason for expedited report rejection by a regulator?

• Complete and clear causality assessment
• Missing essential case identifiers or incorrect expectedness assessment
• Inclusion of laboratory data
• Timely submission within required period

Correct Answer: Missing essential case identifiers or incorrect expectedness assessment

Q24. For marketed products, who often receives 15‑day expedited reports in the US?

• FDA MedWatch/Center for Drug Evaluation and Research (CDER)
• Only the patients
• The local pharmacy only
• The World Bank

Correct Answer: FDA MedWatch/Center for Drug Evaluation and Research (CDER)

Q25. Which responsibility belongs to the investigator regarding expedited reporting?

• Submitting periodic aggregate PSURs to regulators
• Promptly notifying the sponsor of serious adverse events observed at the site
• Creating the E2B transmission format
• Approving the product label

Correct Answer: Promptly notifying the sponsor of serious adverse events observed at the site

Q26. What is the role of follow‑up information after an initial expedited report?

• To withdraw the initial report always
• To provide updated clinical, diagnostic, or outcome information that clarifies the case
• To advertise the product benefits
• To reduce the seriousness of the event automatically

Correct Answer: To provide updated clinical, diagnostic, or outcome information that clarifies the case

Q27. Which of the following best describes a global expedited safety report?

• A report only for domestic marketing issues
• A single expedited report consolidating cases to notify multiple regulatory authorities
• A monthly sales summary
• A manufacturing deviation report

Correct Answer: A single expedited report consolidating cases to notify multiple regulatory authorities

Q28. In assessing whether an event is unexpected, the investigator should compare it to:

• The investigator’s vacation schedule
• The known safety information in the IB or product label
• Random internet posts
• Only the most recent trial participant

Correct Answer: The known safety information in the IB or product label

Q29. What is the significance of timely expedited reporting for public health?

• It has no impact on public health decisions
• It enables rapid risk assessment and protective regulatory actions
• It improves product marketing reach
• It delays label updates permanently

Correct Answer: It enables rapid risk assessment and protective regulatory actions

Q30. Which of the following is a best practice for sponsors to ensure quality expedited reporting?

• Rely solely on verbal reports without documentation
• Implement standardized templates, timely triage, qualified medical review, and E2B-compliant transmission
• Wait for annual meetings to report serious events
• Exclude causality assessment from reports

Correct Answer: Implement standardized templates, timely triage, qualified medical review, and E2B-compliant transmission

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