CIOMS ADR reporting form and structure MCQs With Answer

Introduction: The CIOMS ADR reporting form is a standardized pharmacovigilance tool used worldwide to document adverse drug reactions (ADRs), ensuring consistent case capture for signal detection, regulatory reporting, and safety assessment. B. Pharm students should understand CIOMS structure—patient details, reaction description, suspect drug information, reporter data, seriousness, expectedness, causality and supporting lab results—and related concepts like MedDRA coding, ICH E2B electronic exchange, expedited SUSAR timelines and dechallenge/rechallenge information. Mastery of CIOMS form content helps pharmacists contribute accurately to drug safety, improve post-marketing surveillance, and support clinical trial reporting. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the CIOMS ADR reporting form?

• To standardize adverse drug reaction case reporting for pharmacovigilance
• To replace clinical trial case report forms
• To prescribe dosing regimens for new drugs
• To record financial data of drug sales

Correct Answer: To standardize adverse drug reaction case reporting for pharmacovigilance

Q2. Which major sections are typically included in a CIOMS form?

• Patient information, adverse reaction, suspect drug details, reporter information
• Marketing strategy, patient billing, drug pricing, distribution channels
• Clinical trial randomization list, placebo formulation, CRO budget, informed consent
• Manufacturing lot numbers only

Correct Answer: Patient information, adverse reaction, suspect drug details, reporter information

Q3. CIOMS stands for which organization?

• Council for International Organizations of Medical Sciences
• Clinical Investigation of Medicines and Safety
• Committee for International Oversight of Medical Studies
• Consortium for Institutional Medication Safety

Correct Answer: Council for International Organizations of Medical Sciences

Q4. Which activity is the CIOMS form primarily designed to support?

• Pharmacovigilance case reporting and safety surveillance
• Drug manufacturing quality control
• Patent application drafting
• Hospital financial auditing

Correct Answer: Pharmacovigilance case reporting and safety surveillance

Q5. Where on the CIOMS form is the latency or time-to-onset of the reaction recorded?

• Adverse reaction details / onset date section
• Manufacturer contact section
• Drug batch distribution list
• Marketing authorization date field

Correct Answer: Adverse reaction details / onset date section

Q6. Which of the following is NOT considered a seriousness criterion on CIOMS?

• Mild, self-limiting headache with no medical intervention
• Death
• Life-threatening event
• Hospitalization or prolonged hospitalization

Correct Answer: Mild, self-limiting headache with no medical intervention

Q7. What does “expectedness” refer to in a CIOMS report?

• Whether the reaction is listed in the product labeling or Investigator’s Brochure
• Whether the patient expected to experience side effects
• The marketing expectations for drug uptake
• The expected cost of treatment

Correct Answer: Whether the reaction is listed in the product labeling or Investigator’s Brochure

Q8. Which set of categories is commonly used for causality assessment in ADR reports?

• Certain, probable/likely, possible, unlikely
• High, medium, low, none
• Positive, negative, neutral, unknown
• Immediate, delayed, chronic, recurrent

Correct Answer: Certain, probable/likely, possible, unlikely

Q9. What does the abbreviation SUSAR mean?

• Suspected Unexpected Serious Adverse Reaction
• Standardized Unilateral Safety Adverse Report
• Supply Utilization and Safety Assessment Report
• Serious Unlabeled Safety and Reaction

Correct Answer: Suspected Unexpected Serious Adverse Reaction

Q10. Should concomitant medications be included in a CIOMS report?

• Yes, to help assess potential interactions and alternative causes
• No, they are irrelevant to ADR assessment
• Only if they are over-the-counter drugs
• Only if provided by the manufacturer

Correct Answer: Yes, to help assess potential interactions and alternative causes

Q11. What is the purpose of the narrative section in a CIOMS form?

• To provide a chronological, clinical description of the case and context
• To list the company’s marketing plan for the drug
• To upload the drug’s chemical synthesis steps
• To record pharmacy inventory levels

Correct Answer: To provide a chronological, clinical description of the case and context

Q12. Is reporter contact information required on a CIOMS report?

• Yes, so follow-up queries can be made to clarify the case
• No, anonymity is mandatory for all reports
• Only if the reporter is a physician
• Only for fatal cases

Correct Answer: Yes, so follow-up queries can be made to clarify the case

Q13. Which international standard is commonly used for electronic exchange of CIOMS-style case data?

• ICH E2B (electronic transmission of ICSRs)
• ISO 9001
• HL7 FHIR exclusively for CIOMS
• GMP Annex 1

Correct Answer: ICH E2B (electronic transmission of ICSRs)

Q14. Within how many days must a fatal or life‑threatening SUSAR be reported to regulators in expedited clinical trial reporting?

• 7 calendar days
• 30 days
• 90 days
• Immediately with no specified timeline

Correct Answer: 7 calendar days

Q15. In clinical trials, who is typically responsible for submitting CIOMS-style safety reports to regulatory authorities?

• The trial sponsor
• The trial subject
• The marketing department
• The hospital billing office

Correct Answer: The trial sponsor

Q16. Which field on the CIOMS form records the final status of the patient after the reaction?

• Outcome (recovered, recovering, recovered with sequelae, fatal)
• Marketing authorization status
• Manufacturer’s profit margin
• Clinical trial phase only

Correct Answer: Outcome (recovered, recovering, recovered with sequelae, fatal)

Q17. Why are laboratory and diagnostic test results included in CIOMS reports?

• To support causality assessment and characterize the adverse event
• To provide pricing information for lab services
• To replace the need for clinical history
• They are never included

Correct Answer: To support causality assessment and characterize the adverse event

Q18. Which coding dictionary is most commonly used to code adverse reactions on CIOMS reports?

• MedDRA
• ICD-10 exclusively
• CPT
• SNOMED CT only

Correct Answer: MedDRA

Q19. How should patient identifiers be handled on a CIOMS form to balance follow-up needs and privacy?

• Use a unique patient ID and minimal direct identifiers, allowing follow-up when necessary
• Always include full name, address, and national ID without restriction
• Never include any identifier under any circumstance
• Publish identifiers publicly for transparency

Correct Answer: Use a unique patient ID and minimal direct identifiers, allowing follow-up when necessary

Q20. What is the use of the reporter qualification field on CIOMS?

• To indicate the reporter’s professional qualification (physician, pharmacist, nurse) which aids interpretation
• To report the reporter’s salary
• To list the reporter’s favorite medications
• To record the reporter’s bank details

Correct Answer: To indicate the reporter’s professional qualification (physician, pharmacist, nurse) which aids interpretation

Q21. How does CIOMS reporting contribute to signal detection?

• By providing standardized case data that can be aggregated and analyzed for patterns
• By increasing drug sales through publicity
• By replacing clinical trials for efficacy evaluation
• By encrypting marketing data

Correct Answer: By providing standardized case data that can be aggregated and analyzed for patterns

Q22. Where on the CIOMS form should the suspected drug dose and route be recorded?

• Drug information section (dose, route, frequency, start/stop dates)
• Reporter contact section
• Laboratory section
• Patient outcome section only

Correct Answer: Drug information section (dose, route, frequency, start/stop dates)

Q23. Which of the following is NOT an advantage of using a CIOMS form?

• It guarantees causality assessment is always correct
• It standardizes data for international exchange
• It supports regulatory reporting and signal detection
• It ensures key clinical and drug details are captured consistently

Correct Answer: It guarantees causality assessment is always correct

Q24. Who typically makes the initial causality assessment entered on a CIOMS report?

• The reporter (e.g., treating physician) often provides an initial assessment
• The stock market analyst
• The patient’s family only
• The local newspaper

Correct Answer: The reporter (e.g., treating physician) often provides an initial assessment

Q25. If more than one drug is suspected in a single adverse event, how should this be reported on CIOMS?

• List all suspect and concomitant drugs within the same case report with their roles indicated
• Submit only the first drug ever taken by the patient
• Split the case into unrelated financial reports
• Only report the most expensive drug

Correct Answer: List all suspect and concomitant drugs within the same case report with their roles indicated

Q26. Against what is expectedness of an ADR commonly judged?

• Product labeling (SmPC) or Investigator’s Brochure
• Manufacturer’s marketing materials
• Patient’s expectation of benefit
• Hospital bed availability

Correct Answer: Product labeling (SmPC) or Investigator’s Brochure

Q27. Which section of the CIOMS form captures dechallenge and rechallenge information?

• Course of the adverse reaction / action taken and outcome
• Marketing status section
• Manufacturing process notes
• Insurance billing section

Correct Answer: Course of the adverse reaction / action taken and outcome

Q28. To whom are CIOMS reports most commonly sent for regulatory review?

• National regulatory authorities and competent health agencies
• Retail pharmacies only
• Medical journal editors exclusively
• Advertising agencies

Correct Answer: National regulatory authorities and competent health agencies

Q29. Why is accurate recording of event and drug dates important in CIOMS reports?

• To assess temporal relationship, latency and support causality assessment
• To calculate billing cycles
• To determine marketing quarters
• Dates are unimportant and optional

Correct Answer: To assess temporal relationship, latency and support causality assessment

Q30. Besides small-molecule drugs, for which other therapeutics is the CIOMS format commonly used?

• Biologics and vaccines (to capture safety data consistently)
• Only herbal supplements and food additives
• Only surgical instruments
• It is not applicable beyond tablets

Correct Answer: Biologics and vaccines (to capture safety data consistently)

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