Individual Case Safety Report (ICSR) MCQs With Answer

Individual Case Safety Reports (ICSRs) are the core documents used in pharmacovigilance to record suspected adverse drug reactions. This introduction highlights ICSR purpose, essential data elements (patient details, suspected product, adverse event, seriousness, outcome, batch/lot), regulatory standards such as ICH E2B, MedDRA coding, causality assessment methods, expedited timelines, and case follow-up. Understanding ICSR structure, data quality, expectedness, and signal detection prepares B. Pharm students for pharmacovigilance roles, clinical safety review, and regulatory submissions. Practical MCQs reinforce real-world case processing, electronic submission considerations, and the importance of accurate narrative and source documentation. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of an Individual Case Safety Report (ICSR)?

• To provide detailed clinical trial protocol information
• To document a suspected adverse drug reaction with structured data for pharmacovigilance
• To summarize marketing strategies for a drug
• To record pharmacy inventory levels

Correct Answer: To document a suspected adverse drug reaction with structured data for pharmacovigilance

Q2. Which regulatory guideline defines the electronic transmission standard for ICSR exchange internationally?

• ICH E6 (GCP)
• ICH E2B
• ICH Q9
• Good Pharmacovigilance Practices (GVP)

Correct Answer: ICH E2B

Q3. Which of the following is NOT an essential data element in an ICSR?

• Patient demographics
• Suspected drug and dosage
• Adverse event description and outcome
• Commercial sales figures of the drug

Correct Answer: Commercial sales figures of the drug

Q4. In pharmacovigilance terminology, what does ‘seriousness’ of an adverse event refer to?

• How uncomfortable the patient feels
• Regulatory criteria such as death, life-threatening, hospitalization, disability, congenital anomaly, or other medically important events
• The duration of the event only
• The cost of treatment for the event

Correct Answer: Regulatory criteria such as death, life-threatening, hospitalization, disability, congenital anomaly, or other medically important events

Q5. Which coding dictionary is commonly used to code adverse event terms in ICSRs?

• SNOMED CT
• MedDRA
• LOINC
• ATC only

Correct Answer: MedDRA

Q6. What is the difference between ‘expectedness’ and ‘causality’ in an ICSR context?

• ‘Expectedness’ evaluates if an event matches the product label; ‘causality’ assesses the likelihood the drug caused the event
• They are synonyms and mean the same
• ‘Causality’ checks label content; ‘expectedness’ judges temporal association
• Both relate only to manufacturing defects

Correct Answer: ‘Expectedness’ evaluates if an event matches the product label; ‘causality’ assesses the likelihood the drug caused the event

Q7. Which report type describes unsolicited information about an adverse event from a consumer, healthcare professional, or literature?

• Periodic Safety Update Report (PSUR)
• Spontaneous report
• Clinical study protocol
• Aggregate safety report

Correct Answer: Spontaneous report

Q8. Which element in an ICSR helps uniquely identify the report across systems?

• Patient initials only
• Case reference number or sender case ID
• Marketing authorization holder address
• Event onset year only

Correct Answer: Case reference number or sender case ID

Q9. What is the recommended immediate action when an ICSR describes a life‑threatening adverse event?

• Ignore until periodic report compilation
• Submit expedited or 7/15-day report per regulatory timelines depending on region
• Only record it in local pharmacy logs
• Wait for additional cases to confirm a signal

Correct Answer: Submit expedited or 7/15-day report per regulatory timelines depending on region

Q10. Which causality assessment method is widely used worldwide and is suitable for spontaneous ICSRs?

• Naranjo algorithm
• WHO-UMC causality categories
• Kaplan-Meier estimator
• Fisher exact test

Correct Answer: WHO-UMC causality categories

Q11. In an ICSR, what is the significance of including concomitant medications?

• To estimate pharmacoeconomic impact
• To identify potential interactions or alternative causes for the adverse event
• To record substances for marketing
• They are optional and rarely useful

Correct Answer: To identify potential interactions or alternative causes for the adverse event

Q12. What does follow-up information in an ICSR typically provide?

• Updated clinical course, additional test results, and final outcome
• Marketing approvals in other countries
• Patient satisfaction survey responses
• Manufacturing batch expiry only

Correct Answer: Updated clinical course, additional test results, and final outcome

Q13. Which of the following best describes a solicited ICSR?

• A spontaneous consumer complaint
• A report from an organized data collection system such as a registry, clinical trial, or patient support program
• An advertisement for a drug
• An internal manufacturing incident report

Correct Answer: A report from an organized data collection system such as a registry, clinical trial, or patient support program

Q14. Which piece of information is critical for vaccine ICSRs and pharmacovigilance?

• Medication administration technique only
• Vaccine batch/lot number and manufacturer
• Patient income level
• Prescriber’s marketing preferences

Correct Answer: Vaccine batch/lot number and manufacturer

Q15. What is ‘duplicate detection’ in ICSR processing?

• Finding repeated adverse event terms within one narrative
• Identifying and merging multiple reports that describe the same case from different sources
• Deleting reports older than five years
• Converting narratives to structured fields only

Correct Answer: Identifying and merging multiple reports that describe the same case from different sources

Q16. Under ICH E2B, which message standard version is current for machine-readable ICSR exchange in many regions?

• E2B(R1)
• E2B(R3)
• E2B(R0)
• E2B(R9)

Correct Answer: E2B(R3)

Q17. What role does MedDRA coding of adverse events play in ICSRs?

• It standardizes event terminology to allow aggregate analysis and signal detection
• It translates patient names into codes
• It assigns causality automatically
• It replaces the need for narratives

Correct Answer: It standardizes event terminology to allow aggregate analysis and signal detection

Q18. Which term refers to an unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product?

• Adverse drug reaction (ADR)
• Therapeutic benefit
• Marketing claim
• Prescription error

Correct Answer: Adverse drug reaction (ADR)

Q19. For regulatory expedited reporting, which characteristic combined with seriousness often triggers immediate submission?

• Common event that is nonserious
• Unexpected serious adverse event where the reaction is not listed in the product labeling
• Historical adverse events already documented
• Patient confusion about dosing instructions

Correct Answer: Unexpected serious adverse event where the reaction is not listed in the product labeling

Q20. Which data privacy consideration is important when submitting ICSRs?

• Include full patient identifiers without restriction
• Protect patient confidentiality by using minimal identifiers and following local privacy laws
• Share ICSRs openly on social media
• Convert all data to public domain

Correct Answer: Protect patient confidentiality by using minimal identifiers and following local privacy laws

Q21. In clinical trials, how do ICSRs differ from post-marketing spontaneous reports?

• Clinical trial ICSRs are solicited with protocol-defined reporting requirements and monitored data; spontaneous reports are unsolicited
• They are identical in all aspects
• Spontaneous reports always have more detailed lab data
• Clinical trial ICSRs never require causality assessment

Correct Answer: Clinical trial ICSRs are solicited with protocol-defined reporting requirements and monitored data; spontaneous reports are unsolicited

Q22. What is the value of a clear case narrative in an ICSR?

• It provides a concise, chronological description enabling clinical assessment, causality evaluation, and regulatory review
• It lists marketing approvals only
• It replaces coded terms and thus is optional
• It is only used for billing

Correct Answer: It provides a concise, chronological description enabling clinical assessment, causality evaluation, and regulatory review

Q23. Which action describes a dechallenge in the context of causality assessment?

• Continuing the suspect drug after the event
• Withdrawal of the suspect drug and observing whether the adverse event abates
• Re-administering the suspect drug intentionally
• Changing the formulation of the product

Correct Answer: Withdrawal of the suspect drug and observing whether the adverse event abates

Q24. When is rechallenge information particularly informative in an ICSR?

• When the patient has never taken the drug before
• When the drug is reintroduced and the adverse event recurs, strengthening evidence for causality
• When product advertising is updated
• When the drug is discontinued permanently

Correct Answer: When the drug is reintroduced and the adverse event recurs, strengthening evidence for causality

Q25. What is a key difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)?

• AE implies a causal relationship; ADR does not
• ADR implies a reasonable causal relationship to the drug; AE is any event temporally associated regardless of causality
• They are completely unrelated concepts
• AE is used only in marketing reports

Correct Answer: ADR implies a reasonable causal relationship to the drug; AE is any event temporally associated regardless of causality

Q26. Which narrative element helps establish temporal relationship in an ICSR?

• Exact dates of drug start, onset of event, and stop
• Manufacturer address
• Number of pharmacy dispensations only
• Patient’s favorite color

Correct Answer: Exact dates of drug start, onset of event, and stop

Q27. Which organization or form is commonly used for international harmonization of ICSR terminology and reporting?

• CIOMS forms and templates
• FDA Orange Book exclusively
• ISO clinical lab forms
• Local newspaper reports

Correct Answer: CIOMS forms and templates

Q28. Which outcome field in an ICSR indicates recovery without sequelae?

• Fatal
• Recovered/resolved
• Unknown
• Not recovered

Correct Answer: Recovered/resolved

Q29. What is signal detection in pharmacovigilance using ICSRs?

• Detecting anomalies in sales data
• Identifying potential causal associations between a drug and an adverse event by analyzing aggregated ICSR data
• Designing new marketing campaigns
• Replacing clinical trials entirely

Correct Answer: Identifying potential causal associations between a drug and an adverse event by analyzing aggregated ICSR data

Q30. Which element improves ICSR quality and regulatory utility the most?

• Short, vague narratives
• Complete and accurate data: precise dates, description, lab results, reporter details, and coding
• Omission of seriousness criteria
• Using only free-text without coding

Correct Answer: Complete and accurate data: precise dates, description, lab results, reporter details, and coding

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