ISO 14155: Good clinical practice for device trials MCQs With Answer

Introduction: ISO 14155: Good Clinical Practice for clinical investigations of medical devices provides M.Pharm students a practical framework for designing, conducting, recording and reporting clinical investigations involving human subjects. It aligns scientific integrity with participant protection, defining responsibilities of sponsors, investigators and ethics committees. The standard emphasizes risk-based approaches, device accountability, safety reporting, data quality, informed consent and documentation such as the Clinical Investigation Plan (CIP). Familiarity with ISO 14155 helps regulatory professionals ensure compliance with regional regulations (e.g., EU MDR), design robust trials, interpret clinical evidence for device approval, and prepare for audits and inspections in medical device development.

Q1. Which of the following best describes the main purpose of ISO 14155?

• To regulate manufacturing processes for medical devices
• To provide guidance on design controls for device engineers
• To define Good Clinical Practice requirements for clinical investigations of medical devices
• To replace national ethical regulations for human research

Correct Answer: To define Good Clinical Practice requirements for clinical investigations of medical devices

Q2. ISO 14155 is most directly applicable to which phase of medical device development?

• Non-clinical bench and animal testing only
• Clinical investigation involving human subjects
• Post-market manufacturing quality control
• Marketing and sales activities

Correct Answer: Clinical investigation involving human subjects

Q3. Under ISO 14155, who is primarily responsible for initiating, managing and financing a clinical investigation?

• The ethics committee
• The investigator
• The sponsor
• The regulatory authority

Correct Answer: The sponsor

Q4. Which document is REQUIRED by ISO 14155 to describe objectives, design, methodology, statistical considerations and organization of a clinical investigation?

• Investigator’s Brochure
• Clinical Investigation Plan (CIP)
• Quality Management System Manual
• Device Technical File

Correct Answer: Clinical Investigation Plan (CIP)

Q5. ISO 14155 emphasizes a risk-based approach to monitoring. What is the principal aim of risk-based monitoring?

• To eliminate on-site visits entirely
• To allocate monitoring resources based on trial risk to data integrity and participant safety
• To ensure every data point is 100% source-verified
• To reduce sponsor responsibilities for safety reporting

Correct Answer: To allocate monitoring resources based on trial risk to data integrity and participant safety

Q6. According to ISO 14155, which party must obtain ethics committee (IEC/IRB) approval prior to initiating a clinical investigation?

• The investigator only
• The sponsor only
• Either the sponsor or investigator, but the sponsor must ensure the approval is obtained
• No approval is required for device trials

Correct Answer: Either the sponsor or investigator, but the sponsor must ensure the approval is obtained

Q7. Which statement correctly reflects ISO 14155 requirements about informed consent?

• Informed consent can be verbal if documented in the source records
• Consent must be obtained prior to any trial-specific procedures and documented in writing
• Consent is only required for high-risk devices
• Consent can be obtained after the first diagnostic test

Correct Answer: Consent must be obtained prior to any trial-specific procedures and documented in writing

Q8. In ISO 14155, what is the recommended handling of device accountability during a clinical investigation?

• Devices need not be tracked once delivered to the site
• Maintain records of receipt, use, return and destruction with traceability to subjects
• Only the sponsor must keep device records; investigators are exempt
• Accountability applies only to implantable devices

Correct Answer: Maintain records of receipt, use, return and destruction with traceability to subjects

Q9. How does ISO 14155 define a Serious Adverse Event (SAE) in the context of device clinical investigations?

• An event that is inconvenient but resolves quickly
• Any device malfunction without clinical consequences
• An untoward medical occurrence that results in death, is life-threatening, requires hospitalization or causes persistent disability
• An expected technical failure recorded during bench testing

Correct Answer: An untoward medical occurrence that results in death, is life-threatening, requires hospitalization or causes persistent disability

Q10. ISO 14155 requires reporting of device deficiencies. Which of the following best describes a device deficiency?

• Any expected clinical outcome documented in the CIP
• A malfunction, degradation or inadequacy of labeling leading to or potentially leading to harm
• A delay in shipping devices to the site
• An investigator’s administrative error unrelated to the device

Correct Answer: A malfunction, degradation or inadequacy of labeling leading to or potentially leading to harm

Q11. Which record retention period does ISO 14155 generally recommend for clinical investigation records?

• At least 1 year after study completion
• Retention as specified by applicable national regulations; typically several years beyond clinical investigation end
• Records may be destroyed immediately after final report submission
• Only electronic records need long-term retention

Correct Answer: Retention as specified by applicable national regulations; typically several years beyond clinical investigation end

Q12. Which of the following is a key difference between ISO 14155 and ICH GCP (E6) when applied to medical devices?

• ISO 14155 does not require informed consent
• ISO 14155 addresses device-specific issues such as device performance, usability and device accountability not covered in detail by ICH GCP
• ICH GCP applies only to devices, not drugs
• There are no differences; they are identical

Correct Answer: ISO 14155 addresses device-specific issues such as device performance, usability and device accountability not covered in detail by ICH GCP

Q13. Under ISO 14155, what is the role of the Investigator in a clinical investigation?

• To design the device technical file
• To conduct the study at the site, ensure subject safety, obtain consent and maintain accurate records
• To finance the study and manage regulatory submissions
• To perform market analysis for the device

Correct Answer: To conduct the study at the site, ensure subject safety, obtain consent and maintain accurate records

Q14. What does ISO 14155 recommend regarding monitoring plans?

• Monitoring should be the same for all studies regardless of risk
• Monitoring activities should be described in a monitoring plan and based on risk assessment
• Monitoring plans are optional and not recommended
• Only remote monitoring is permitted under ISO 14155

Correct Answer: Monitoring activities should be described in a monitoring plan and based on risk assessment

Q15. Which statistical aspect is specifically emphasized by ISO 14155 in the design of clinical investigations?

• That no statistical analysis is required for device trials
• Clear definition of endpoints, sample size justification and preplanned analysis methods
• Only descriptive statistics are permitted
• That all trials must use Bayesian methods

Correct Answer: Clear definition of endpoints, sample size justification and preplanned analysis methods

Q16. How should protocol deviations be managed according to ISO 14155?

• They may be ignored if they are minor
• They must be documented, investigated, and reported per the CIP and sponsor procedures
• Deviations should be concealed to protect study integrity
• Only deviations leading to SAEs need documentation

Correct Answer: They must be documented, investigated, and reported per the CIP and sponsor procedures

Q17. ISO 14155 requires that data management practices ensure which of the following?

• That only paper records are acceptable
• Confidentiality, data integrity, traceability and appropriate access control
• That raw data can be altered without audit trail
• That data ownership always resides with investigators

Correct Answer: Confidentiality, data integrity, traceability and appropriate access control

Q18. In relation to regulatory submissions, how does ISO 14155 support the preparation of evidence for market approval?

• By providing technical specifications for device manufacturing only
• By defining good practices for clinical data generation, documentation and reporting to demonstrate safety and performance
• By replacing the need for any clinical evidence
• By mandating specific marketing claims

Correct Answer: By defining good practices for clinical data generation, documentation and reporting to demonstrate safety and performance

Q19. What is the significance of post-market clinical follow-up (PMCF) in the context of ISO 14155 and device lifecycle?

• PMCF is irrelevant to ISO 14155
• PMCF provides ongoing data on safety and performance to support continuous benefit-risk evaluation
• PMCF replaces pre-market clinical investigations
• PMCF only concerns device labeling updates

Correct Answer: PMCF provides ongoing data on safety and performance to support continuous benefit-risk evaluation

Q20. Which of the following best describes the relationship between ISO 14155 and national/regional regulations (e.g., EU MDR)?

• Compliance with ISO 14155 automatically guarantees regulatory approval everywhere
• ISO 14155 provides international good practice guidance that should be implemented in accordance with applicable national/regional regulatory requirements
• ISO 14155 conflicts with regional laws and should be avoided
• ISO 14155 is only an internal sponsor document with no regulatory relevance

Correct Answer: ISO 14155 provides international good practice guidance that should be implemented in accordance with applicable national/regional regulatory requirements

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