Ethics and clinical investigation plans for medical devices MCQs With Answer

Ethics and clinical investigation plans for medical devices MCQs With Answer

This quiz set is designed for M.Pharm students studying Regulatory Aspects of Medical Devices (MRA203T). It focuses on ethical principles and the practical components of clinical investigation plans for medical devices, integrating regulatory guidance such as ISO 14155, the Declaration of Helsinki, and regional investigational device requirements. Questions test understanding of informed consent, risk–benefit assessment, vulnerable populations, sponsor and investigator responsibilities, study design elements, safety reporting, and post-market clinical follow-up. The aim is to deepen comprehension of how ethical safeguards and robust clinical planning ensure patient safety and reliable evidence for device approval and clinical use.

Q1. Which international standard specifically provides guidance on the design, conduct, recording and reporting of clinical investigations for medical devices?

• Good Clinical Practice (ICH E6)
• ISO 14155
• OECD GLP
• ISO 9001

Correct Answer: ISO 14155

Q2. According to ethical principles, which document is primarily cited regarding the protection of human research subjects and providing guidance on informed consent?

• ICH E2A
• Declaration of Helsinki
• ISO 13485
• Good Manufacturing Practice (GMP)

Correct Answer: Declaration of Helsinki

Q3. Which element is NOT typically required in a clinical investigation plan (CIP) for a medical device?

• Study objectives and hypotheses
• Batch-release manufacturing certificates for commercial lots
• Statistical analysis plan and sample size justification
• Safety reporting and monitoring procedures

Correct Answer: Batch-release manufacturing certificates for commercial lots

Q4. In device clinical investigations, the primary rationale for including a comparator arm is to:

• Reduce manufacturing costs during the trial
• Mask the sponsor identity
• Allow assessment of relative safety and performance
• Ensure faster regulatory approval automatically

Correct Answer: Allow assessment of relative safety and performance

Q5. Which population is considered vulnerable and requires special protections in clinical investigations of medical devices?

• Healthy adult volunteers in phase I trials only
• Pediatric subjects and cognitively impaired persons
• Licensed clinicians acting as investigators
• Regulatory reviewers assessing dossiers

Correct Answer: Pediatric subjects and cognitively impaired persons

Q6. Under ISO 14155, who has primary responsibility for ensuring the investigational device is used according to the protocol at an investigational site?

• The sponsor’s marketing department
• The principal investigator
• The ethics committee chair
• The device manufacturer’s sales representative

Correct Answer: The principal investigator

Q7. Which is the most appropriate justification for waiver of informed consent in a device study?

• The study is intended to increase product sales
• Emergency situation where consent cannot reasonably be obtained and treatment is time-critical
• Investigator prefers not to burden subjects with paperwork
• All trials conducted in low-risk devices

Correct Answer: Emergency situation where consent cannot reasonably be obtained and treatment is time-critical

Q8. Which component is essential in the benefit–risk assessment for a clinical investigation of a new implantable device?

• Only the cosmetic design of the device
• Magnitude and probability of harms versus expected clinical benefits
• Price point relative to competitors
• Number of manufacturing employees

Correct Answer: Magnitude and probability of harms versus expected clinical benefits

Q9. Which regulatory submission is commonly required in the US before initiating a clinical investigation of a significant-risk medical device?

• New Drug Application (NDA)
• Investigational Device Exemption (IDE)
• Biologics License Application (BLA)
• Pre-market Notification 510(k) only

Correct Answer: Investigational Device Exemption (IDE)

Q10. In clinical investigations, an SAE (serious adverse event) should be reported to the sponsor and competent authorities within what context-driven timeframe?

• Only at study end
• Immediately or within the regulatory-specified expedited reporting timeframe
• When the investigator has time
• Only if the media requests information

Correct Answer: Immediately or within the regulatory-specified expedited reporting timeframe

Q11. Demonstrating equivalence to a predicate device typically requires which type of evidence?

• Only marketing materials
• Comparative bench testing, performance data, and sometimes clinical data
• Unverified anecdotal reports from users
• Patent documents alone

Correct Answer: Comparative bench testing, performance data, and sometimes clinical data

Q12. Which study design feature increases ethical acceptability when testing an invasive device with potential for significant harm?

• Using the largest possible sample size regardless of power calculations
• Including interim analyses with predefined stopping rules for harm
• Delaying monitoring until after study completion
• Excluding data safety monitoring altogether

Correct Answer: Including interim analyses with predefined stopping rules for harm

Q13. Post-market clinical follow-up (PMCF) is primarily intended to:

• Replace premarket clinical evidence completely
• Collect ongoing safety and performance data in real-world use
• Increase sales through clinical advertising
• Reduce regulatory oversight permanently

Correct Answer: Collect ongoing safety and performance data in real-world use

Q14. Which element must be included in the informed consent form for a device clinical investigation?

• Guaranteed clinical benefit for the subject
• Statement of voluntary participation and right to withdraw without penalty
• Investigator’s private medical opinions about other patients
• Exact market launch date of the device

Correct Answer: Statement of voluntary participation and right to withdraw without penalty

Q15. Which statistical concept is critical to justify the number of subjects enrolled in a device trial?

• Sample size calculation based on pre-specified primary endpoint and desired power
• Recruiting as many subjects as possible without rationale
• Avoiding any pretrial estimate to preserve flexibility
• Choosing a sample size equal to competitor trials regardless of endpoint

Correct Answer: Sample size calculation based on pre-specified primary endpoint and desired power

Q16. Which action by a sponsor best supports data integrity during a clinical investigation?

• Allowing untracked changes to source documents
• Implementing audit trails, validated systems, and controlled access
• Using unsecured spreadsheets without version control
• Permitting investigators to alter electronic records without documentation

Correct Answer: Implementing audit trails, validated systems, and controlled access

Q17. When a clinical investigation protocol requires a device modification during the study, the correct regulatory/ethical step is to:

• Implement the change immediately at all sites without notification
• Evaluate impact on safety/effectiveness and obtain IEC/competent authority approval or notification as required
• Publish the modification only after study completion
• Ignore documentation and continue as before

Correct Answer: Evaluate impact on safety/effectiveness and obtain IEC/competent authority approval or notification as required

Q18. Which responsibility belongs to the ethics committee (IEC/IRB) reviewing a medical device clinical investigation?

• Manufacturing the investigational device
• Assessing the scientific validity and protecting participant rights and welfare
• Marketing the device upon approval
• Setting device pricing strategies

Correct Answer: Assessing the scientific validity and protecting participant rights and welfare

Q19. Adaptive study designs for device trials are acceptable when:

• Planned prospectively with statistical control and documented in the CIP
• Implemented ad hoc without protocol amendments
• Used to conceal poor early results
• Never disclosed to regulators

Correct Answer: Planned prospectively with statistical control and documented in the CIP

Q20. Which post-approval activity is most important for identifying rare or long-term adverse events associated with a medical device?

• Short-term pilot studies only
• Robust post-market surveillance and registries
• Exclusive reliance on premarket randomized trials of small size
• Marketing claims without clinical follow-up

Correct Answer: Robust post-market surveillance and registries

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