Conflicts of interest and vendor relations MCQs With Answer

Introduction: This collection of multiple-choice questions on Conflicts of Interest and Vendor Relations is designed for M.Pharm students preparing for exams and practical decision-making in research and clinical settings. The questions cover financial and non‑financial conflicts, disclosure requirements, institutional policies, ethical management strategies, vendor selection and procurement practices, influence of sponsors on study design and data, and mechanisms to mitigate bias such as independent monitoring, contracts and audits. Each item tests conceptual understanding and application to real‑world situations pharmacists encounter in academic research, clinical trials, procurement, and industry collaborations, helping build skills to recognize, disclose and manage conflicts that could affect research integrity and patient safety.

Q1. What best defines a financial conflict of interest in a clinical research setting?

• Any secondary interest that could influence professional judgment, regardless of monetary value
• Ownership of equity in a sponsoring company which may be affected by the study outcome
• Personal friendship with a study participant
• Academic rivalry with another investigator

Correct Answer: Ownership of equity in a sponsoring company which may be affected by the study outcome

Q2. Which action is the most appropriate initial step when an investigator identifies a potential conflict of interest?

• Ignore it if the amount involved is small
• Privately alter the study protocol to avoid mentioning the conflict
• Disclose the conflict to the institutional conflict-of-interest committee and relevant stakeholders
• Delegate all responsibilities to a junior colleague without documentation

Correct Answer: Disclose the conflict to the institutional conflict-of-interest committee and relevant stakeholders

Q3. Which of the following is a non-financial conflict of interest?

• Receiving consulting fees from a device vendor
• Holding a patent on the investigational product
• Desire for career advancement through positive trial results
• Ownership of stock in the sponsor company

Correct Answer: Desire for career advancement through positive trial results

Q4. In vendor relations, what is the primary objective of conducting vendor qualification and auditing?

• To increase vendor market share
• To ensure vendor compliance with quality standards and protect study integrity and patient safety
• To expedite payments to vendors
• To ensure vendors advertise their services to more investigators

Correct Answer: To ensure vendor compliance with quality standards and protect study integrity and patient safety

Q5. Which institutional mechanism most directly manages conflicts of interest in research?

• Research promotion office
• Conflict-of-interest (COI) committee or panel
• Procurement department
• Student disciplinary board

Correct Answer: Conflict-of-interest (COI) committee or panel

Q6. Which practice is considered unethical when interacting with pharmaceutical or device vendors?

• Accepting vendor-provided samples for unbiased scientific evaluation with institutional approval
• Allowing vendor representatives to draft the final clinical study report without independent review
• Having vendors provide product training to research staff under supervision
• Requiring vendors to sign confidentiality and data ownership agreements

Correct Answer: Allowing vendor representatives to draft the final clinical study report without independent review

Q7. Which document best protects data ownership and clarifies responsibilities between an academic investigator and a commercial vendor?

• Oral agreement between principal investigator and vendor
• Material Transfer Agreement (MTA) or a formal contract specifying data rights
• Vendor marketing brochure
• Internal lab notebook without external signatures

Correct Answer: Material Transfer Agreement (MTA) or a formal contract specifying data rights

Q8. Which of the following is an effective strategy to mitigate bias introduced by a vendor-sponsored statistical analysis?

• Allowing only vendor statisticians to access raw data
• Engaging an independent statistician or a blinded data analysis plan
• Permitting the sponsor to decide which endpoints to report
• Publishing only positive analyses

Correct Answer: Engaging an independent statistician or a blinded data analysis plan

Q9. When is recusal appropriate in the context of vendor selection for a trial?

• When a committee member has no prior relationship with any vendor
• When a committee member has a direct financial interest in one of the bidding vendors
• When a vendor bids the lowest price
• When the vendor is the only known supplier for a product

Correct Answer: When a committee member has a direct financial interest in one of the bidding vendors

Q10. Which guideline or regulation specifically provides principles for good clinical practice and sponsor responsibilities that help reduce conflicts?

• ICH-GCP (International Council for Harmonisation — Good Clinical Practice)
• Hippocratic Oath
• Patent Law
• International Accounting Standards

Correct Answer: ICH-GCP (International Council for Harmonisation — Good Clinical Practice)

Q11. What is the most appropriate policy regarding gifts from vendors to investigators involved in clinical research?

• Accept any gift if it is under a personally agreed threshold
• Prohibit acceptance of gifts that could influence or appear to influence professional judgment, with transparent disclosure of permitted low-value items per policy
• Accept lavish gifts to secure favorable treatment
• Record gifts only if requested by the vendor

Correct Answer: Prohibit acceptance of gifts that could influence or appear to influence professional judgment, with transparent disclosure of permitted low-value items per policy

Q12. Which clause in a contract helps prevent sponsor control over publication of negative findings?

• Clause assigning patent rights to the sponsor only
• Publication rights clause guaranteeing investigator ability to publish results within a reasonable time frame
• Clause allowing sponsor to redact all adverse events
• Clause transferring all data to sponsor with no investigator access

Correct Answer: Publication rights clause guaranteeing investigator ability to publish results within a reasonable time frame

Q13. Which scenario best describes a secondary interest compromising objectivity in study conduct?

• Investigator holds a grant from a neutral public funding agency
• Investigator receives honoraria from the company that manufactures the study drug and is responsible for endpoint adjudication
• Investigator uses standard validated outcome measures
• Investigator declares all financial relationships to the ethics committee

Correct Answer: Investigator receives honoraria from the company that manufactures the study drug and is responsible for endpoint adjudication

Q14. What is an appropriate institutional response if a vendor is found to have falsified quality documentation during an audit?

• Ignore the finding to avoid disrupting the study
• Terminate vendor contract, notify regulators if required, perform root-cause analysis and take corrective actions
• Allow the vendor to continue without corrective action
• Reduce oversight to maintain vendor relations

Correct Answer: Terminate vendor contract, notify regulators if required, perform root-cause analysis and take corrective actions

Q15. How should an institution handle minor, routine vendor-supplied samples used for training that may create perceived conflicts?

• Ban all samples regardless of educational value
• Allow use under documented institutional policy with disclosure and oversight to avoid perceived bias
• Permit unrestricted vendor-led training without oversight
• Require payment to the vendor for all samples

Correct Answer: Allow use under documented institutional policy with disclosure and oversight to avoid perceived bias

Q16. Which factor increases the risk that vendor relationships will bias research outcomes?

• Transparent, contractual agreements detailing roles and data access
• Vendor involvement in protocol development, data collection, analysis and publication without independent oversight
• Use of independent data monitoring committees
• Public registration of study protocol and pre-specified analysis plan

Correct Answer: Vendor involvement in protocol development, data collection, analysis and publication without independent oversight

Q17. What is the role of institutional procurement policies in minimizing conflicts with vendors?

• To increase individualized deals for investigators without oversight
• To standardize vendor selection, ensure competitive bidding, document decisions and reduce favoritism and undue influence
• To appoint vendors based solely on personal recommendations
• To eliminate written contracts to speed up purchases

Correct Answer: To standardize vendor selection, ensure competitive bidding, document decisions and reduce favoritism and undue influence

Q18. Which practice strengthens independence of safety assessments in sponsored clinical trials?

• Allowing the sponsor sole control of the safety database
• Establishing an independent Data Safety Monitoring Board (DSMB) with access to unblinded data
• Having site investigators report only favorable events
• Requiring all safety queries be resolved by the vendor alone

Correct Answer: Establishing an independent Data Safety Monitoring Board (DSMB) with access to unblinded data

Q19. Which statement best describes an effective conflict-of-interest management plan for an investigator who owns stock in a sponsor?

• The investigator continues full control of all trial aspects without disclosure
• Disclosure of the interest, divestiture or recusal from decision-making roles, and oversight by an independent party as required
• The investigator hides the ownership to avoid administrative burden
• The institution guarantees preferential enrollment to the investigator’s studies

Correct Answer: Disclosure of the interest, divestiture or recusal from decision-making roles, and oversight by an independent party as required

Q20. Why is pre-registration of trials and pre-specification of analysis plans important in the context of sponsor and vendor relations?

• It allows sponsors to change endpoints after seeing interim data
• It minimizes selective reporting and post-hoc analytic manipulation that could be influenced by sponsors or vendors
• It hides negative results from regulators
• It permits vendors to control the publication timeline

Correct Answer: It minimizes selective reporting and post-hoc analytic manipulation that could be influenced by sponsors or vendors

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