Safety data collection in clinical phase MCQs With Answer

Safety data collection in clinical phase studies is a core component of pharmacovigilance and drug development for B.Pharm students. This introduction covers essential keywords such as adverse events (AEs), serious adverse events (SAEs), SUSARs, case report forms (CRFs), MedDRA coding, electronic data capture (EDC), causality assessment, reporting timelines, data monitoring, and risk management. Understanding investigator and sponsor responsibilities, regulatory reporting requirements, signal detection, and audit-ready documentation prepares students for real-world clinical safety tasks. Clear, accurate safety data supports patient protection, informed consent, and regulatory decisions throughout phases I–III. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of safety data collection during clinical phases?

• To measure drug efficacy only
• To document adverse events and protect participant safety
• To recruit more participants
• To reduce study costs

Correct Answer: To document adverse events and protect participant safety

Q2. Which term describes an adverse event that results in death, is life‑threatening, requires hospitalization, or causes disability?

• Non‑serious adverse event
• Expected adverse event
• Serious adverse event (SAE)
• Adverse reaction

Correct Answer: Serious adverse event (SAE)

Q3. What is a SUSAR?

• A suspected unexpected serious adverse reaction
• A standardized safety assessment report
• A study unblinded safety analysis report
• A site‑user safety audit record

Correct Answer: A suspected unexpected serious adverse reaction

Q4. Which coding dictionary is commonly used to code adverse events in clinical trials?

• ICD‑10
• MedDRA
• SNOMED CT
• LOINC

Correct Answer: MedDRA

Q5. Which document outlines sponsor responsibilities for safety reporting and aggregate safety review?

• Investigator brochure (IB)
• Clinical study protocol
• Risk Management Plan (RMP) and ICH guidelines
• Informed consent form (ICF)

Correct Answer: Risk Management Plan (RMP) and ICH guidelines

Q6. Which timeline is typically required for reporting a fatal or life‑threatening SUSAR to regulators?

• Within 7 calendar days
• Within 15 business days
• Within 90 days
• At study end

Correct Answer: Within 7 calendar days

Q7. What is the function of a Data Safety Monitoring Board (DSMB)?

• To recruit participants
• To independently review safety data and recommend study continuation or modification
• To perform laboratory assays
• To manage study finances

Correct Answer: To independently review safety data and recommend study continuation or modification

Q8. Which form records detailed SAE information at the trial site?

• Investigator site file
• Serious Adverse Event (SAE) form
• Case report form (CRF) for efficacy only
• Monitoring visit log

Correct Answer: Serious Adverse Event (SAE) form

Q9. What is causality assessment in safety reporting?

• Determining if the event fulfills regulatory timelines
• Assessing the likelihood that the investigational product caused the adverse event
• Counting the number of adverse events
• Classifying events as expected or unexpected

Correct Answer: Assessing the likelihood that the investigational product caused the adverse event

Q10. Which system is used for electronic submission of safety reports internationally (ICH standard)?

• EudraVigilance only
• ICH E2B(R3) electronic common technical document
• ICH E2B format for electronic transmission
• MedDRA transmission protocol

Correct Answer: ICH E2B format for electronic transmission

Q11. What is an aggregate safety review?

• Site‑by‑site monitoring report
• Periodic analysis of pooled safety data to identify trends and signals
• Single case narrative review
• Banking of biological samples

Correct Answer: Periodic analysis of pooled safety data to identify trends and signals

Q12. Which parameter is most important when defining a dose‑limiting toxicity in phase I trials?

• Cost of the drug
• Frequency of expected side effects
• Severity and clinical consequence of the adverse event
• Ease of sample collection

Correct Answer: Severity and clinical consequence of the adverse event

Q13. What role does the investigator have in safety data collection?

• Only to recruit participants
• To detect, document, assess, and report AEs and SAEs promptly
• To write the final regulatory submission
• To design the MedDRA dictionary

Correct Answer: To detect, document, assess, and report AEs and SAEs promptly

Q14. Which is an essential field on an SAE form?

• Patient’s favorite food
• Onset date and outcome of the event
• Number of site staff
• Study budget code

Correct Answer: Onset date and outcome of the event

Q15. What is signal detection in pharmacovigilance?

• The process of enrolling more subjects
• Identifying new or changing risks from cumulative safety data
• Assigning MedDRA codes only
• Blinding the trial for safety

Correct Answer: Identifying new or changing risks from cumulative safety data

Q16. Which report summarizes annual safety information for regulators during development?

• Investigator brochure (IB) update
• Development Safety Update Report (DSUR)
• Annual study budget
• Ad hoc safety memo

Correct Answer: Development Safety Update Report (DSUR)

Q17. Why is MedDRA preferred over free‑text reporting in clinical trials?

• It allows structured, standardized coding for analysis and signal detection
• It increases the number of reported events
• It avoids the need for SAE forms
• It replaces causality assessment

Correct Answer: It allows structured, standardized coding for analysis and signal detection

Q18. What is the importance of source data verification (SDV) in safety data?

• To hide discrepancies in CRFs
• To check CRF entries against original records for accuracy
• To change MedDRA terms
• To submit data to the DSMB

Correct Answer: To check CRF entries against original records for accuracy

Q19. Which regulatory concept ensures rapid assessment when an SAE is both unexpected and related to the investigational drug?

• Aggregate review
• Expedited reporting
• Annual report submission
• Routine monitoring

Correct Answer: Expedited reporting

Q20. In blinded trials, when is unblinding permitted for safety reasons?

• Never allowed
• Only if necessary to manage a participant’s medical care
• At investigator discretion for any minor event
• After study completion only

Correct Answer: Only if necessary to manage a participant’s medical care

Q21. What does EDC stand for and why is it used?

• Electronic Data Capture; to collect, store, and manage trial data efficiently
• Early Drug Clearance; to approve drugs faster
• External Data Consultation; to outsource monitoring
• Electronic Drug Code; to label medications

Correct Answer: Electronic Data Capture; to collect, store, and manage trial data efficiently

Q22. How should pregnancy exposure during a clinical trial be reported?

• Not reported because it is unrelated
• Recorded and reported as a safety event with follow‑up of outcome
• Only recorded at study end
• Reported only if the drug is known teratogen

Correct Answer: Recorded and reported as a safety event with follow‑up of outcome

Q23. Which guideline provides international standards for clinical safety data management?

• ICH E6 Good Clinical Practice only
• ICH E2A/E2B for pharmacovigilance safety reporting
• EMA‑only local guidance
• ISO 9001 quality manual

Correct Answer: ICH E2A/E2B for pharmacovigilance safety reporting

Q24. What is an expected adverse event?

• An event not listed in the protocol
• An event listed in the Investigator Brochure or product information as previously observed
• An event caused by a concomitant medication only
• A lab error

Correct Answer: An event listed in the Investigator Brochure or product information as previously observed

Q25. Which element is critical for assessing clinical significance of lab abnormalities?

• Only the absolute value without trend
• Baseline comparison, magnitude of change, and clinical context
• The site’s daily temperature
• Time of day the sample was taken only

Correct Answer: Baseline comparison, magnitude of change, and clinical context

Q26. What is the investigator brochure (IB) used for in safety collection?

• To provide study funding details
• To summarize preclinical and clinical safety information for investigators
• To replace informed consent
• To code AEs in MedDRA

Correct Answer: To summarize preclinical and clinical safety information for investigators

Q27. Which action improves quality of safety data collection at sites?

• Minimizing staff training to save time
• Regular safety training, clear CRF instructions, and timely monitoring
• Allowing backdated SAE entries
• Using handwritten logs without verification

Correct Answer: Regular safety training, clear CRF instructions, and timely monitoring

Q28. What is the role of expedited reporting to ethics committees?

• Not required if sponsor reports to regulators
• To inform ethics committees of serious safety concerns affecting participants
• To request more funding
• To change the primary endpoint

Correct Answer: To inform ethics committees of serious safety concerns affecting participants

Q29. Which is a key output of pharmacovigilance signal assessment?

• Final marketing price
• Risk minimization measures or further investigations
• Change in enrollment criteria only
• Replacement of the study drug

Correct Answer: Risk minimization measures or further investigations

Q30. What should be included in a high‑quality SAE narrative?

• Vague summaries and opinions
• Clear chronology, relevant history, treatments, outcome, and causality assessment
• Only lab values without context
• Site administrative details

Correct Answer: Clear chronology, relevant history, treatments, outcome, and causality assessment

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