Research objectives and requirements MCQs With Answer

This quiz collection on “Research objectives and requirements” is designed specifically for M.Pharm students preparing for exams and research projects. It covers core concepts such as framing specific and measurable objectives, SMART criteria, operational definitions, primary versus secondary objectives, feasibility, ethics, sample size implications, pilot studies, and practical requirements for conducting robust pharmaceutical research. Each question tests applied understanding essential for designing, justifying, and executing a research study in pharmacy practice, pharmacology, pharmaceutics, or clinical research. Use these MCQs to reinforce conceptual clarity, improve protocol writing skills, and prepare for viva or theory examinations.

Q1. What distinguishes a specific research objective from a general research objective?

• A broad statement of intent without measurable details
• A concise, measurable statement detailing what will be achieved
• An open-ended research question to explore possibilities
• An informal description of background rationale

Correct Answer: A concise, measurable statement detailing what will be achieved

Q2. In the SMART criteria for good objectives, what does the “M” represent?

• Methodological
• Measurable
• Meaningful
• Manageable

Correct Answer: Measurable

Q3. Which of the following is NOT a desirable characteristic of a well-written specific objective?

• Clear
• Measurable
• Vague
• Time-bound

Correct Answer: Vague

Q4. How does a research objective primarily differ from a research question?

• A research question prescribes statistical tests; objectives do not
• Objectives state intended outcomes in measurable terms; research questions pose the problem to be answered
• Research questions are always quantitative; objectives are qualitative
• Objectives are optional elements of a protocol while research questions are mandatory

Correct Answer: Objectives state intended outcomes in measurable terms; research questions pose the problem to be answered

Q5. Which statement best reflects the role of the primary objective in a clinical study?

• The primary objective is optional and used only for exploratory analyses
• The primary objective determines the main outcome and usually drives sample size calculation
• The primary objective refers only to safety outcomes, not efficacy
• The primary objective is always identical to every secondary objective

Correct Answer: The primary objective determines the main outcome and usually drives sample size calculation

Q6. Why are operational definitions important when stating objectives?

• They provide theoretical justification but do not affect measurement
• They ensure consistent, replicable measurement of variables
• They replace the need for a clear objective
• They allow arbitrary interpretation of outcomes by investigators

Correct Answer: They ensure consistent, replicable measurement of variables

Q7. Which element typically follows directly from a hypothesis when designing objectives?

• Selection of irrelevant endpoints
• Specification of measurable outcomes for testing the hypothesis
• Removal of inclusion/exclusion criteria
• Arbitrary selection of sample size without calculation

Correct Answer: Specification of measurable outcomes for testing the hypothesis

Q8. What does the PICO framework stand for when formulating clinical research objectives?

• Population, Intervention, Comparison, Outcome
• Patient, Intervention, Control, Observation
• Problem, Indicator, Context, Outcome
• Protocol, Intervention, Compliance, Outcome

Correct Answer: Population, Intervention, Comparison, Outcome

Q9. Before initiating a human-subjects study, which requirement is universally essential?

• Completion of all data analysis
• Approval from an institutional ethics committee
• Publication of the protocol
• Recruitment of at least half the required sample

Correct Answer: Approval from an institutional ethics committee

Q10. When assessing feasibility of objectives, which factor is LEAST relevant?

• Availability of qualified personnel and equipment
• Projected timeline and budget constraints
• Researcher’s personal preference for a particular result
• Access to the target participant population

Correct Answer: Researcher’s personal preference for a particular result

Q11. Which of the following would be considered a surrogate endpoint in a pharmacological study?

• All-cause mortality
• Patient-reported quality of life score
• Blood biomarker level correlated with clinical outcome
• Time to hospital discharge

Correct Answer: Blood biomarker level correlated with clinical outcome

Q12. The primary purpose of inclusion and exclusion criteria in a study protocol is to:

• Maximize recruitment speed regardless of safety
• Enhance internal validity and ensure participant safety
• Make the study results applicable to every possible population
• Eliminate the need for informed consent

Correct Answer: Enhance internal validity and ensure participant safety

Q13. Which factor most directly influences the sample size calculation for a study?

• The number of investigators on the team
• The primary objective, expected effect size, and variability
• The font size used in the protocol document
• The number of secondary objectives

Correct Answer: The primary objective, expected effect size, and variability

Q14. When is conducting a pilot study most appropriate?

• After the main trial to confirm results
• Before the main study to test feasibility, recruitment, and procedures
• Only when no objectives are defined
• When the sample size is already excessively large

Correct Answer: Before the main study to test feasibility, recruitment, and procedures

Q15. Which phrasing is recommended when writing specific objectives in a protocol?

• Using vague descriptive phrases like “to explore”
• Stating aims in infinitive form such as “To compare…” with measurable outcomes
• Embedding objectives within lengthy background text only
• Listing objectives as rhetorical questions

Correct Answer: Stating aims in infinitive form such as “To compare…” with measurable outcomes

Q16. Which of the following would be an example of an objective that is NOT specific?

• To compare systolic blood pressure change between drug A and placebo at 12 weeks
• To assess the incidence of adverse events during treatment
• To study the effects of a drug
• To evaluate medication adherence using pill counts over 6 months

Correct Answer: To study the effects of a drug

Q17. Why is a data management plan considered a key requirement when defining study requirements?

• It replaces the need for ethical approval
• It ensures data quality, integrity, storage, and compliance with regulations
• It mandates publication regardless of results
• It limits investigator access to study data permanently

Correct Answer: It ensures data quality, integrity, storage, and compliance with regulations

Q18. Which objective formulation is most directly testable by statistical hypothesis testing?

• To describe participant demographics in a population
• To test whether Drug X reduces LDL cholesterol more than placebo after 12 weeks
• To explore possible correlations without predefined endpoints
• To archive biological samples for future undefined research

Correct Answer: To test whether Drug X reduces LDL cholesterol more than placebo after 12 weeks

Q19. Which of these is an example of a poorly defined objective for a pharmaceutical study?

• To determine the minimum inhibitory concentration (MIC) of antibiotic Y against strain Z
• To evaluate dose-response of drug B on blood glucose over 8 weeks
• To improve patient outcomes
• To compare pharmacokinetics of formulation A and B in healthy volunteers

Correct Answer: To improve patient outcomes

Q20. How should ethical considerations influence the framing of research objectives?

• Objectives should minimize participant risk and ensure potential benefits justify the research
• Ethics should be considered only after objectives are achieved
• Objectives should prioritize scientific novelty over participant safety
• Ethical review is unnecessary if objectives are clearly written

Correct Answer: Objectives should minimize participant risk and ensure potential benefits justify the research

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