ICH expedited reporting requirements MCQs With Answer

Introduction: ICH expedited reporting requirements MCQs With Answer is a focused review designed for B. Pharm students studying pharmacovigilance and clinical safety. This concise guide explains key ICH concepts—such as SUSARs, SAEs, ICH E2A/E2B frameworks, timelines for expedited reports, ICSR elements, sponsor responsibilities, and follow‑up reporting—using practical multiple‑choice questions. Emphasis is placed on regulatory timelines (7 and 15 calendar days), data standards, causality assessment, and differences between expedited and periodic reporting. The questions reinforce deeper understanding needed for drug safety roles and regulatory compliance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the ICH definition of an expedited reportable SUSAR?

• A non‑serious adverse event that is expected and unrelated to the investigational product
• A serious and unexpected adverse reaction suspected to be caused by the investigational product
• A periodic safety update sent every six months
• An administrative report to ethics committees only

Correct Answer: A serious and unexpected adverse reaction suspected to be caused by the investigational product

Q2. Which ICH guideline primarily addresses expedited reporting of adverse events in clinical trials?

• ICH E1
• ICH E2A
• ICH Q3A
• ICH M4

Correct Answer: ICH E2A

Q3. According to ICH, what is the initial reporting timeline for fatal or life‑threatening SUSARs?

• 24 hours
• 7 calendar days
• 30 calendar days
• 90 calendar days

Correct Answer: 7 calendar days

Q4. For non‑fatal, non‑life‑threatening SUSARs, ICH recommends initial reporting within:

• 48 hours
• 7 calendar days
• 15 calendar days
• 60 calendar days

Correct Answer: 15 calendar days

Q5. Who is principally responsible for submitting expedited SUSAR reports to regulatory authorities?

• The clinical investigator only
• The study sponsor
• The patient
• The ethics committee secretary

Correct Answer: The study sponsor

Q6. Which ICH guideline specifies data elements and electronic transmission standards for Individual Case Safety Reports (ICSRs)?

• ICH E2A
• ICH E2B
• ICH E6
• ICH S6

Correct Answer: ICH E2B

Q7. Which element is NOT an essential component of an expedited ICSR per ICH standards?

• Identifiable patient
• Suspected medicinal product
• Complete genome sequence of the patient
• Description of the adverse reaction

Correct Answer: Complete genome sequence of the patient

Q8. In ICH expedited reporting, what does SAE stand for?

• Supplementary Adverse Event
• Serious Adverse Event
• Standard Adverse Evaluation
• Systemic Adverse Episode

Correct Answer: Serious Adverse Event

Q9. The term “unexpected” in SUSAR refers to:

• An event never seen with any drug
• An event not listed in the current investigator brochure or product labeling
• An event that is always mild
• An administrative error

Correct Answer: An event not listed in the current investigator brochure or product labeling

Q10. Which of the following best differentiates expedited reporting from periodic safety reporting?

• Expedited reporting concerns aggregate annual summaries; periodic is immediate
• Expedited reporting is for individual serious unexpected cases; periodic reporting summarizes safety over defined intervals
• Both are identical in content and timing
• Periodic reporting is only for manufacturing defects

Correct Answer: Expedited reporting is for individual serious unexpected cases; periodic reporting summarizes safety over defined intervals

Q11. What is a primary purpose of expedited SUSAR reporting to investigators and regulators?

• To support marketing strategies
• To ensure subject safety and allow rapid risk minimization
• To delay clinical trial procedures
• To reduce paperwork at the end of a trial

Correct Answer: To ensure subject safety and allow rapid risk minimization

Q12. According to ICH, follow‑up information to an initial expedited report should be:

• Never provided
• Provided only at the end of the trial
• Provided as soon as available with any new relevant data
• Sent yearly with aggregate statistics

Correct Answer: Provided as soon as available with any new relevant data

Q13. Which report type is most likely to require expedited reporting: an ADR that is non‑serious and expected, or a serious unexpected suspected adverse reaction?

• Non‑serious and expected ADR
• Serious unexpected suspected adverse reaction
• Both equally
• Neither — only periodic reports apply

Correct Answer: Serious unexpected suspected adverse reaction

Q14. What does ICSR stand for in pharmacovigilance reporting?

• International Case Safety Report
• Individual Case Safety Report
• Immediate Clinical Safety Record
• Indexed Causality Safety Report

Correct Answer: Individual Case Safety Report

Q15. Which of the following best describes causality assessment in expedited reporting?

• A definitive proof that the drug caused the event
• An evaluation of the likelihood that the drug is related to the adverse event
• An unrelated administrative classification
• A method to calculate drug potency

Correct Answer: An evaluation of the likelihood that the drug is related to the adverse event

Q16. The ICH E2B(R3) standard is primarily concerned with:

• Clinical trial statistical analysis
• Electronic transmission format for ICSRs
• Manufacturing quality control
• Ethics committee membership criteria

Correct Answer: Electronic transmission format for ICSRs

Q17. Which of the following is a required content element in an expedited clinical SUSAR report?

• Source code of the electronic data capture system
• Action taken with the investigational product
• Detailed billing information
• Investigator’s national ID number only

Correct Answer: Action taken with the investigational product

Q18. Who should an investigator normally notify first when a SUSAR occurs at a trial site?

• The site janitor
• The study sponsor and the Institutional Review Board/Independent Ethics Committee per local rules
• Only the patient
• The marketing department

Correct Answer: The study sponsor and the Institutional Review Board/Independent Ethics Committee per local rules

Q19. Which term describes an adverse event with a reasonable possibility of causal relationship to a medicinal product?

• Suspected adverse reaction
• Confirmed disease
• Placebo response
• Non‑related event

Correct Answer: Suspected adverse reaction

Q20. In the context of expedited reporting, “expectedness” is determined by:

• Whether the event is listed in the current investigator brochure or product label
• The frequency of the event in the general population only
• The sponsor’s marketing plan
• How many sites reported the event

Correct Answer: Whether the event is listed in the current investigator brochure or product label

Q21. The CIOMS form is commonly used for:

• Manufacturing batch release
• Reporting individual adverse drug reactions in a structured way
• Clinical trial randomization
• Insurance claims processing

Correct Answer: Reporting individual adverse drug reactions in a structured way

Q22. An expedited report should include which of the following patient identifiers (when available)?

• Complete home address and bank details
• Age or date of birth and sex
• Only the investigator’s phone number
• No patient information at all

Correct Answer: Age or date of birth and sex

Q23. Which is a common regulatory action that can follow timely expedited reporting of SUSARs?

• Immediate trial termination without review
• Risk minimization measures, protocol amendments, or temporary holds pending review
• Automatic publication in marketing brochures
• Reduction of monitoring visits only

Correct Answer: Risk minimization measures, protocol amendments, or temporary holds pending review

Q24. Which organization’s guidelines are harmonized by the ICH for safety reporting between regions?

• World Trade Organization (WTO)
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
• International Monetary Fund (IMF)
• World Health Organization’s trade division

Correct Answer: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Q25. For post‑marketing expedited reports (serious unexpected ADRs), the usual regulatory expectation under ICH is to report within:

• One year
• 15 calendar days for initial reports where applicable
• No reporting required after marketing
• Only at marketing authorization renewal

Correct Answer: 15 calendar days for initial reports where applicable

Q26. Which of the following is TRUE about expedited reporting confidentiality?

• Patient identifiable information should always be published publicly
• Reports should protect patient privacy while providing enough detail for assessment
• Confidentiality is irrelevant in pharmacovigilance
• Only sponsor identities must be concealed

Correct Answer: Reports should protect patient privacy while providing enough detail for assessment

Q27. Which is the correct sequence when a SUSAR occurs during a multinational trial?

• Sponsor assesses causality → decides on expedited report → submits to relevant regulatory authorities and investigators per local requirements
• Investigator publishes the event without informing sponsor
• Sponsor waits until the end of trial to aggregate all events
• No action required outside the site

Correct Answer: Sponsor assesses causality → decides on expedited report → submits to relevant regulatory authorities and investigators per local requirements

Q28. What role does the investigator brochure (IB) play in expedited reporting?

• It is the source document to determine if an event is expected or unexpected
• It replaces all regulatory submissions
• It is only a marketing leaflet
• It contains the final CSR only

Correct Answer: It is the source document to determine if an event is expected or unexpected

Q29. Which of the following best describes a follow‑up expedited report?

• A report that retracts the initial report
• A report providing additional clinical or laboratory information after the initial notification
• An annual safety report summary
• Only a financial reconciliation

Correct Answer: A report providing additional clinical or laboratory information after the initial notification

Q30. Which statement about electronic submission of expedited ICSRs is correct?

• ICH E2B enables standardized electronic transmission of ICSRs across regions
• Electronic submission is prohibited by ICH
• Only paper CIOMS forms are acceptable
• Electronic submissions require no standard format

Correct Answer: ICH E2B enables standardized electronic transmission of ICSRs across regions

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com