Role of hospital pharmacist and advisory committee in clinical research MCQs With Answer

Introduction: The role of a hospital pharmacist and advisory committee in clinical research is central to safe, ethical, and compliant trials. Hospital pharmacists manage investigational medicinal product (IMP) storage, labeling, drug accountability, dispensing, temperature monitoring, and investigational drug destruction. Advisory committees such as Institutional Ethics Committees (IEC) and Data Safety Monitoring Boards (DSMB) review protocols, protect participant rights, ensure informed consent, and oversee adverse event reporting and pharmacovigilance. Understanding Good Clinical Practice (GCP), regulatory compliance, protocol adherence, and documentation is essential for B.Pharm students. This topic-focused set of MCQs covers practical responsibilities, regulatory concepts, ethics, and quality systems to prepare students for clinical research roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary responsibility of the hospital pharmacist in clinical trials?

• Designing the study protocol
• Managing investigational drug storage, labeling, accountability, and safe handling
• Recruiting study participants
• Performing statistical analysis

Correct Answer: Managing investigational drug storage, labeling, accountability, and safe handling

Q2. Which committee primarily reviews the ethical aspects of a clinical trial?

• Data Safety Monitoring Board (DSMB)
• Institutional Ethics Committee (IEC)
• Sponsor’s Clinical Operations Team
• Pharmacy and Therapeutics Committee

Correct Answer: Institutional Ethics Committee (IEC)

Q3. Which guideline emphasizes protecting the rights, safety, and well-being of trial subjects?

• ICH-GCP
• Good Laboratory Practice
• ISO 9001
• Pharmacopoeia standards

Correct Answer: ICH-GCP

Q4. What document provides detailed clinical and nonclinical information about an investigational product?

• Investigator Brochure
• Informed Consent Form
• Case Report Form
• Trial Master File index

Correct Answer: Investigator Brochure

Q5. Which activity is a routine pharmacy responsibility during a clinical trial?

• Writing the statistical analysis plan
• Maintaining drug accountability logs and performing reconciliations
• Conducting subject randomization
• Approving the final protocol

Correct Answer: Maintaining drug accountability logs and performing reconciliations

Q6. Who is responsible for obtaining informed consent from a participant?

• Sponsor representative
• Pharmacy technician
• Investigator or delegated qualified staff
• Regulatory authority

Correct Answer: Investigator or delegated qualified staff

Q7. An investigator discovers a serious adverse event (SAE). What is the immediate action?

• Wait for the next monitoring visit
• Report immediately to the sponsor and follow local reporting timelines to IEC/regulatory bodies
• Destroy the remaining IMP
• Unblind the entire study

Correct Answer: Report immediately to the sponsor and follow local reporting timelines to IEC/regulatory bodies

Q8. Pharmacovigilance in clinical research primarily involves:

• Designing clinical trial budgets
• Detection, assessment, and prevention of adverse drug reactions
• Manufacturing the investigational product
• Marketing post-approval products

Correct Answer: Detection, assessment, and prevention of adverse drug reactions

Q9. Proper handling of a temperature excursion for IMP requires:

• Immediate dispensing to participants
• Quarantine, documentation, assessment, and sponsor notification
• Ignoring if deviation is short
• Discarding without documentation

Correct Answer: Quarantine, documentation, assessment, and sponsor notification

Q10. Randomization in clinical trials is used to:

• Ensure every subject gets the active drug
• Prevent selection bias and achieve balanced groups
• Blind the investigator
• Reduce sample size requirements

Correct Answer: Prevent selection bias and achieve balanced groups

Q11. Blinding in a clinical study primarily reduces which type of bias?

• Selection bias
• Performance and assessment bias
• Reporting bias only
• Manufacturing bias

Correct Answer: Performance and assessment bias

Q12. Essential elements of drug accountability records include:

• Temperature logs only
• Participant demographics only
• Dates, quantities received, dispensed, returned, and destroyed
• Investigator curriculum vitae

Correct Answer: Dates, quantities received, dispensed, returned, and destroyed

Q13. Emergency unblinding should be performed when:

• The study ends
• A subject’s safety requires knowledge of treatment assignment
• The pharmacy is short-staffed
• To satisfy a monitoring visit curiosity

Correct Answer: A subject’s safety requires knowledge of treatment assignment

Q14. Destruction of unused investigational product should be:

• Performed without witnesses
• Recorded, witnessed, and authorized per sponsor and regulatory SOPs
• Left for the next study team member to decide
• Returned to participants

Correct Answer: Recorded, witnessed, and authorized per sponsor and regulatory SOPs

Q15. When a temperature monitoring alarm indicates a breach, the pharmacist should first:

• Immediately redistribute IMP
• Document the excursion, quarantine affected stock, and notify sponsor/QA
• Ignore if the alarm occurred at night
• Adjust the thermostat and resume use

Correct Answer: Document the excursion, quarantine affected stock, and notify sponsor/QA

Q16. The Data Safety Monitoring Board (DSMB) is primarily tasked with:

• Approving the trial budget
• Independent monitoring of safety data and recommending trial modifications or stoppage
• Recruiting participants
• Labeling investigational products

Correct Answer: Independent monitoring of safety data and recommending trial modifications or stoppage

Q17. A major protocol deviation is best defined as one that:

• Does not affect subject safety or data quality
• Potentially affects subject safety, rights, or the integrity of study data
• Is a minor paperwork error
• Occurs only during screening

Correct Answer: Potentially affects subject safety, rights, or the integrity of study data

Q18. ICH-GCP stands for:

• International Council for Harmonisation — Good Clinical Practice
• Internal Compliance Handbook — Good Clinical Protocol
• Institute of Clinical Health — Global Clinical Procedures
• International Committee of Hospitals — GMP

Correct Answer: International Council for Harmonisation — Good Clinical Practice

Q19. An Institutional Ethics Committee should include:

• Only clinicians from the sponsoring department
• Multidisciplinary members including at least one lay person, clinician, and legal or social scientist
• Only pharmacists and statisticians
• Only regulatory inspectors

Correct Answer: Multidisciplinary members including at least one lay person, clinician, and legal or social scientist

Q20. Key elements that must appear in an informed consent form include:

• Only the study title and sponsor name
• Purpose, procedures, risks, benefits, alternatives, confidentiality, and voluntary participation
• Investigator’s salary details
• Marketing plans for the drug

Correct Answer: Purpose, procedures, risks, benefits, alternatives, confidentiality, and voluntary participation

Q21. Phase I clinical trials primarily assess:

• Efficacy in large patient populations
• Long-term post-marketing safety
• Safety, tolerability, and pharmacokinetics in a small group
• Cost-effectiveness compared to standard care

Correct Answer: Safety, tolerability, and pharmacokinetics in a small group

Q22. A source document is:

• A secondary summary used only for audits
• The original document where clinical observations and data are first recorded
• A promotional brochure for the IMP
• The final published article

Correct Answer: The original document where clinical observations and data are first recorded

Q23. Trial Master File (TMF) retention is important because it:

• Is optional and can be discarded after publication
• Provides documented evidence of trial conduct and must be retained as per regulatory requirements
• Is used to store IMP at room temperature
• Replaces individual subject records

Correct Answer: Provides documented evidence of trial conduct and must be retained as per regulatory requirements

Q24. The sponsor’s primary responsibility in a clinical trial is to:

• Provide IRB members
• Design, finance, and ensure overall conduct and regulatory compliance of the trial
• Enroll subjects at the site
• Perform all laboratory assays locally

Correct Answer: Design, finance, and ensure overall conduct and regulatory compliance of the trial

Q25. The investigator’s main responsibilities include:

• Ensuring protocol compliance, subject safety, informed consent, and accurate data collection
• Manufacturing the IMP
• Approving the sponsor’s marketing plan
• Setting regulatory policy

Correct Answer: Ensuring protocol compliance, subject safety, informed consent, and accurate data collection

Q26. Monitoring differs from auditing in that monitoring is:

• Independent and retrospective
• Ongoing, site-focused oversight to ensure data accuracy and subject safety
• Only concerned with financial issues
• Unrelated to regulatory compliance

Correct Answer: Ongoing, site-focused oversight to ensure data accuracy and subject safety

Q27. Use of placebo is ethically acceptable when:

• There is a proven effective therapy and it is withheld
• No proven effective therapy exists or withholding standard therapy does not cause harm
• To intentionally deceive regulators
• It reduces study costs regardless of subject risk

Correct Answer: No proven effective therapy exists or withholding standard therapy does not cause harm

Q28. Justification for sub-therapeutic dosing in a protocol must be provided because:

• It simplifies pharmacy procedures
• It may affect subject safety and study validity and requires scientific and ethical justification
• Sub-therapeutic doses are always safer
• It eliminates the need for informed consent

Correct Answer: It may affect subject safety and study validity and requires scientific and ethical justification

Q29. Inclusion and exclusion criteria are important to:

• Make recruitment arbitrarily difficult
• Protect participant safety and ensure appropriate study population for valid results
• Bias the study toward positive outcomes
• Eliminate the need for monitoring

Correct Answer: Protect participant safety and ensure appropriate study population for valid results

Q30. The hospital pharmacist’s role in adverse drug reaction reporting includes:

• Collecting, documenting, assessing, and forwarding ADR reports to pharmacovigilance center or sponsor
• Ignoring non-serious events
• Only reporting to social media
• Destroying ADR records after one week

Correct Answer: Collecting, documenting, assessing, and forwarding ADR reports to pharmacovigilance center or sponsor

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