Protocol development for research studies MCQs With Answer

Introduction: Protocol development for research studies is a fundamental skill for B. Pharm students, covering research protocol design, study objectives, methodology, sample size estimation, ethical approval, data management, case report forms (CRFs), and monitoring plans. A good protocol ensures scientific validity, regulatory compliance (GCP, ICH), patient safety, and clear statistical analysis plans and endpoints. Learning protocol writing emphasizes inclusion/exclusion criteria, informed consent, adverse event reporting, SOPs, and trial logistics like randomization, blinding, and investigational product handling. Mastery of these elements prepares pharmacy graduates for clinical research, regulatory roles, and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a research study protocol?

• To provide a marketing plan for the investigational product
• To outline the experimental procedures and ensure study reproducibility
• To replace informed consent documents
• To register participants for insurance purposes

Correct Answer: To outline the experimental procedures and ensure study reproducibility

Q2. Which section of a protocol explains why the study is needed and summarizes prior research?

• Statistical analysis plan
• Background and rationale
• Monitoring plan
• Case report form (CRF)

Correct Answer: Background and rationale

Q3. Which of the following is a primary endpoint?

• A secondary safety outcome
• Exploratory biomarker analysis
• The main outcome used to answer the primary research question
• Ancillary pharmacokinetic measurement

Correct Answer: The main outcome used to answer the primary research question

Q4. What does GCP stand for in clinical research?

• General Clinical Procedures
• Good Clinical Practice
• Global Compliance Policy
• Guideline for Clinical Pharmacology

Correct Answer: Good Clinical Practice

Q5. Which part of the protocol details how participants are selected?

• Statistical analysis plan
• Eligibility criteria (inclusion and exclusion)
• Data management plan
• Monitoring and audit plan

Correct Answer: Eligibility criteria (inclusion and exclusion)

Q6. Randomization in a trial primarily aims to:

• Ensure blinding of the investigator only
• Control confounding by distributing known and unknown factors evenly
• Guarantee the best treatment for each participant
• Reduce sample size requirements

Correct Answer: Control confounding by distributing known and unknown factors evenly

Q7. Which document captures individual participant data during a clinical study?

• Investigator brochure
• Case report form (CRF)
• Informed consent form
• Regulatory submission dossier

Correct Answer: Case report form (CRF)

Q8. Blinding in a study is intended to:

• Prevent regulatory inspections
• Reduce assessment bias by keeping participants or investigators unaware of treatment assignments
• Ensure faster recruitment
• Increase the number of endpoints

Correct Answer: Reduce assessment bias by keeping participants or investigators unaware of treatment assignments

Q9. Which regulatory body typically reviews and approves clinical study protocols for ethical conduct?

• Data Safety Monitoring Board
• Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
• Pharmacy procurement committee
• Marketing authorization holder

Correct Answer: Institutional Review Board (IRB) or Independent Ethics Committee (IEC)

Q10. A Statistical Analysis Plan (SAP) should be:

• Developed after database lock to avoid bias
• Drafted before data unblinding to predefine analyses
• Only descriptive without inferential methods
• Optional for exploratory studies

Correct Answer: Drafted before data unblinding to predefine analyses

Q11. Which guideline provides standards for reporting randomized clinical trials?

• ICH-GCP only
• CONSORT statement
• Good Laboratory Practice (GLP)
• ICH M7

Correct Answer: CONSORT statement

Q12. Sample size calculation depends primarily on all EXCEPT:

• Expected effect size
• Desired statistical power
• Significance level (alpha)
• Number of study monitors

Correct Answer: Number of study monitors

Q13. An interim analysis is performed to:

• Replace the final analysis entirely
• Assess safety or efficacy partway through a trial and possibly stop early
• Avoid ethics committee oversight
• Increase the sample size arbitrarily

Correct Answer: Assess safety or efficacy partway through a trial and possibly stop early

Q14. Which component specifies how adverse events are recorded and reported?

• Inclusion criteria section
• Pharmacovigilance and safety reporting section
• Background and rationale
• Investigator CVs

Correct Answer: Pharmacovigilance and safety reporting section

Q15. Informed consent ensures that participants:

• Are automatically compensated for all harms
• Understand the study, risks, benefits, and voluntarily agree to participate
• Are blinded to treatment allocation
• Cannot withdraw once enrolled

Correct Answer: Understand the study, risks, benefits, and voluntarily agree to participate

Q16. A protocol amendment is required when:

• No changes occur during the study
• Significant changes to study design, procedures, or safety information are needed
• Only minor typographical errors are found
• Data has been analyzed and published

Correct Answer: Significant changes to study design, procedures, or safety information are needed

Q17. What is the role of a Data Safety Monitoring Board (DSMB)?

• Manufacture investigational drugs
• Independently monitor participant safety and trial conduct
• Write the final clinical study report
• Recruit study participants

Correct Answer: Independently monitor participant safety and trial conduct

Q18. Which study design is most appropriate to compare two treatments while minimizing bias?

• Randomized controlled trial
• Case report
• Cross-sectional survey
• Single-arm open-label study

Correct Answer: Randomized controlled trial

Q19. The investigator brochure primarily contains:

• Study recruitment advertisements
• Comprehensive information on the investigational product for investigators
• Final statistical outputs
• Participant billing details

Correct Answer: Comprehensive information on the investigational product for investigators

Q20. What is a protocol synopsis?

• A detailed lab manual for assays
• A concise summary of key protocol elements for quick review
• The final peer-reviewed publication
• An unrelated regulatory form

Correct Answer: A concise summary of key protocol elements for quick review

Q21. Which of the following best describes a pilot study?

• A large randomized efficacy trial
• A small-scale preliminary study to test feasibility and refine methods
• An animal toxicity study
• A final confirmatory phase

Correct Answer: A small-scale preliminary study to test feasibility and refine methods

Q22. Confidentiality in clinical research refers to:

• Publishing all patient identifiers with datasets
• Protecting participant personal data and limiting access
• Sharing raw data publicly without consent
• Allowing sponsor unrestricted access to participant homes

Correct Answer: Protecting participant personal data and limiting access

Q23. Protocol deviations are:

• Planned study changes documented before initiation
• Unplanned departures from the protocol that may require documentation and reporting
• Always grounds for study termination
• Synonymous with protocol amendments

Correct Answer: Unplanned departures from the protocol that may require documentation and reporting

Q24. Multicenter studies require which additional protocol element?

• Single-site informed consent only
• Harmonized procedures and site-specific regulatory approvals
• No monitoring plan
• Only one CRF for all sites with no site identifiers

Correct Answer: Harmonized procedures and site-specific regulatory approvals

Q25. Which guideline set is commonly referenced for international clinical trial conduct?

• ICH E6 (Good Clinical Practice)
• EU GMP Annex 1 only
• WHO food safety manual
• ISO 9000 exclusively

Correct Answer: ICH E6 (Good Clinical Practice)

Q26. Which element of a protocol outlines handling, storage, and accountability of the investigational product?

• Statistical analysis plan
• Investigational product management section
• Background and rationale
• Patient recruitment flyer

Correct Answer: Investigational product management section

Q27. What is the primary reason to predefine inclusion and exclusion criteria?

• To limit recruitment speed
• To ensure a clear, reproducible study population and protect participant safety
• To allow any patient to enroll
• To avoid ethics committee review

Correct Answer: To ensure a clear, reproducible study population and protect participant safety

Q28. Which document must participants sign before joining a clinical study?

• Investigator brochure
• Informed consent form
• Statistical analysis plan
• Regulatory submission cover letter

Correct Answer: Informed consent form

Q29. Monitoring visits are conducted to:

• Train participants on drug administration
• Verify data accuracy, protocol compliance, and participant safety
• Replace the role of the ethics committee
• Perform final data analysis

Correct Answer: Verify data accuracy, protocol compliance, and participant safety

Q30. Which is a critical element of data management described in a protocol?

• Only keeping paper files without backups
• Data handling procedures, quality control, and database security
• Publishing participant identifiers publicly
• Allowing unrestricted edits to source documents

Correct Answer: Data handling procedures, quality control, and database security

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