Clinical research protocols and ethical considerations MCQs With Answer

Clinical research protocols and ethical considerations MCQs With Answer is an essential review for B. Pharm students preparing for careers in drug development and clinical trials. This concise guide covers protocol design, informed consent, ICH-GCP principles, IRB/IEC review, safety reporting, randomization, blinding, sample size, data integrity, regulatory compliance, vulnerable populations, and trial monitoring. Emphasis on patient safety, risk–benefit assessment, confidentiality, adverse event management, and protocol adherence builds strong ethical and scientific judgment. These keyword-rich topics help reinforce theoretical knowledge and practical decision-making in clinical research. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which section of a clinical research protocol most clearly defines primary and secondary endpoints?

• Study background and rationale
• Objectives and endpoints
• Statistical analysis plan
• Safety monitoring plan

Correct Answer: Objectives and endpoints

Q2. Which regulatory guideline is considered the international standard for Good Clinical Practice?

• Declaration of Helsinki
• ICH-GCP
• FDA 21 CFR Part 11
• EMA Clinical Trials Regulation

Correct Answer: ICH-GCP

Q3. What is the primary ethical requirement before enrolling a subject in a clinical trial?

• Obtaining informed consent
• Randomization
• IRB approval after enrollment
• Baseline laboratory tests

Correct Answer: Obtaining informed consent

Q4. Which committee is responsible for ethical review of a protocol at a hospital or institution?

• Data Safety Monitoring Board
• Institutional Review Board / Independent Ethics Committee
• Sponsor’s Clinical Operations Group
• Regulatory Authority

Correct Answer: Institutional Review Board / Independent Ethics Committee

Q5. Which design feature minimizes selection bias by ensuring unpredictable treatment allocation?

• Open-label assignment
• Randomization with allocation concealment
• Block enrollment without concealment
• Historical control comparison

Correct Answer: Randomization with allocation concealment

Q6. What is the main purpose of blinding in a clinical trial?

• Improve recruitment speed
• Reduce measurement and observer bias
• Lower study costs
• Ensure faster regulatory approval

Correct Answer: Reduce measurement and observer bias

Q7. Which document specifically informs subjects about risks, benefits, and alternatives before participation?

• Case report form
• Informed consent form
• Investigator’s brochure
• Protocol synopsis

Correct Answer: Informed consent form

Q8. Serious adverse events (SAEs) must be reported to regulators and ethics committees within what context?

• Only at study completion
• Immediately or per regulatory timelines
• Only if fatal
• Only during data analysis

Correct Answer: Immediately or per regulatory timelines

Q9. Which element of a protocol describes inclusion and exclusion criteria?

• Study population and selection criteria
• Statistical analysis
• Data management plan
• Trial registration details

Correct Answer: Study population and selection criteria

Q10. What is the primary role of a Data Safety Monitoring Board (DSMB)?

• Write the informed consent form
• Provide independent safety oversight and recommend stopping rules
• Manage site budgets
• Recruit patients for the trial

Correct Answer: Provide independent safety oversight and recommend stopping rules

Q11. Which statistical concept estimates the number of participants needed to detect a predefined effect?

• Randomization
• Sample size calculation
• Interim analysis
• Protocol deviation

Correct Answer: Sample size calculation

Q12. What is a protocol deviation?

• An amendment approved by the IRB
• A departure from the approved protocol
• A data cleaning activity
• Planned interim analysis

Correct Answer: A departure from the approved protocol

Q13. Which principle requires that the potential benefits to participants and society outweigh the risks?

• Justice
• Beneficence and non-maleficence (risk–benefit assessment)
• Confidentiality
• Autonomy

Correct Answer: Beneficence and non-maleficence (risk–benefit assessment)

Q14. Which process ensures trial data are accurate, complete, and verifiable from source documents?

• Source data verification and monitoring
• Randomization
• Informed consent
• Protocol drafting

Correct Answer: Source data verification and monitoring

Q15. Which registry is commonly used to make clinical trials publicly accessible before enrollment?

• ClinicalTrials.gov
• PubMed
• Google Scholar
• ICH Database

Correct Answer: ClinicalTrials.gov

Q16. When is an investigator required to obtain re-consent from participants?

• When minor typographical errors are found in the protocol
• When new significant safety information changes risk–benefit profile
• At every study visit regardless of content
• Only at study closure

Correct Answer: When new significant safety information changes risk–benefit profile

Q17. Which document provides comprehensive preclinical and clinical data about an investigational product?

• Investigator’s brochure
• Protocol amendments
• Case report form
• Consent log

Correct Answer: Investigator’s brochure

Q18. What is allocation concealment intended to prevent?

• Loss to follow-up
• Selection bias during enrollment
• Incorrect data entry
• Delayed safety reporting

Correct Answer: Selection bias during enrollment

Q19. Which population is considered vulnerable and requires additional protections in trials?

• Healthy adult volunteers only
• Children, pregnant women, cognitively impaired individuals
• All clinical trial participants equally
• Investigators and study staff

Correct Answer: Children, pregnant women, cognitively impaired individuals

Q20. What is the ethical issue with using a placebo when an effective treatment exists?

• Placebo always improves outcomes
• It may withhold proven therapy, raising ethical concerns
• Placebo reduces sample size requirements
• Placebo eliminates need for informed consent

Correct Answer: It may withhold proven therapy, raising ethical concerns

Q21. Which term describes planned interim checks of trial data to assess safety or efficacy?

• Final analysis
• Interim analysis
• Source data review
• Adverse event coding

Correct Answer: Interim analysis

Q22. What is the main function of an institutional standard operating procedure (SOP) in clinical research?

• Describe detailed, consistent processes for study activities
• Replace the protocol entirely
• Increase variability among sites
• Serve as the informed consent form

Correct Answer: Describe detailed, consistent processes for study activities

Q23. In GCP, whose responsibility is the integrity of trial data and overall conduct of the study?

• The sponsor and the principal investigator share responsibility
• The study participants
• The IRB alone
• Only the data manager

Correct Answer: The sponsor and the principal investigator share responsibility

Q24. What is meant by “confidentiality” in clinical research?

• Keeping the protocol secret from regulators
• Protecting participant-identifiable information from unauthorized access
• Publishing all participant data publicly
• Allowing access to all study staff regardless of need

Correct Answer: Protecting participant-identifiable information from unauthorized access

Q25. Which action is required if a protocol amendment increases participant risk?

• Implement immediately without approval
• Submit amendment for IRB/IEC approval and re-consent participants if needed
• Ignore and proceed as planned
• Only inform the sponsor verbally

Correct Answer: Submit amendment for IRB/IEC approval and re-consent participants if needed

Q26. What is pharmacovigilance in the context of clinical trials?

• Marketing the investigational product
• Detection, assessment, and prevention of adverse effects
• Randomization technique
• Protocol drafting process

Correct Answer: Detection, assessment, and prevention of adverse effects

Q27. Which endpoint type directly measures how a patient feels, functions, or survives?

• Surrogate endpoint
• Clinical outcome (patient‑centered) endpoint
• Laboratory endpoint only
• Pharmacokinetic endpoint

Correct Answer: Clinical outcome (patient‑centered) endpoint

Q28. What is informed assent?

• Consent from the sponsor
• A minor’s agreement to participate, alongside parental consent
• Investigator’s approval signature
• Automated enrollment procedure

Correct Answer: A minor’s agreement to participate, alongside parental consent

Q29. Which factor is crucial when selecting study sites for multi-center trials?

• Proximity to sponsor headquarters only
• Investigator experience, patient population, and infrastructure
• Lowest operational cost only
• Sites with no prior trials experience

Correct Answer: Investigator experience, patient population, and infrastructure

Q30. What is the primary purpose of trial registration before patient enrollment?

• Protect intellectual property exclusively
• Promote transparency, reduce publication bias, and inform the public
• Replace ethical review
• Enable automatic approval by regulators

Correct Answer: Promote transparency, reduce publication bias, and inform the public

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