ISO 14155 for medical device trials MCQs With Answer

Introduction
ISO 14155 is the internationally recognized standard for Good Clinical Practice (GCP) in clinical investigations of medical devices. For M.Pharm students, understanding ISO 14155 is essential because it bridges clinical methodology, regulatory requirements, and patient safety specific to devices. The standard defines responsibilities of sponsors, investigators and ethics committees; requirements for clinical investigation plans, informed consent, risk management and monitoring; and expectations for data integrity, reporting of adverse events and post-investigation activities. Familiarity with ISO 14155 helps pharmacy graduates contribute to device trials, ensure compliance with regulations, support ethical conduct, and interpret trial documentation, making it a core competency for careers in clinical research and regulatory affairs.

Q1. What is the primary objective of ISO 14155 in clinical investigations of medical devices?

• To set manufacturing quality control procedures for medical devices
• To provide guidelines for marketing strategies of medical devices
• To protect the rights, safety and well-being of human subjects and ensure clinical data credibility
• To describe sterilization processes for implantable devices

Correct Answer: To protect the rights, safety and well-being of human subjects and ensure clinical data credibility

Q2. Under ISO 14155, who holds primary responsibility for initiating, managing and financing a clinical investigation?

• Investigator
• Manufacturer
• Sponsor
• Ethics committee

Correct Answer: Sponsor

Q3. Which document outlines the objectives, design, methodology, statistical considerations and organization of a clinical investigation according to ISO 14155?

• Device Technical File
• Clinical Investigation Plan (CIP)
• Quality Management Manual
• Informed Consent Form

Correct Answer: Clinical Investigation Plan (CIP)

Q4. ISO 14155 requires that informed consent be obtained from subjects prior to participation. Which of the following is a key requirement for the informed consent process?

• Consent may be verbal only if documented in the investigator’s diary
• Consent must be obtained after the subject has been given adequate time and information to decide
• Consent can be waived for all device trials
• The sponsor can sign consent on behalf of the subject

Correct Answer: Consent must be obtained after the subject has been given adequate time and information to decide

Q5. Which role is primarily responsible for conducting the clinical investigation at the site and ensuring adherence to the CIP?

• Regulatory authority
• Investigator
• Sponsor delegate
• Manufacturer’s quality auditor

Correct Answer: Investigator

Q6. According to ISO 14155, which committee must approve the clinical investigation before it begins?

• Data Safety Monitoring Board (DSMB)
• Ethics committee/Institutional Review Board (IRB)
• Manufacturing oversight committee
• Marketing approval committee

Correct Answer: Ethics committee/Institutional Review Board (IRB)

Q7. ISO 14155 emphasizes risk management for medical device investigations. Which standard is most directly referenced for device risk management practices?

• ISO 9001
• ISO 13485
• ISO 14971
• ISO 27001

Correct Answer: ISO 14971

Q8. How should serious adverse events (SAEs) be handled according to ISO 14155?

• Recorded in the trial master file and reported promptly to sponsor and competent authorities as required
• Only recorded locally and not reported externally
• Reported at the end of the clinical investigation in the final report
• Ignored if related to device misuse

Correct Answer: Recorded in the trial master file and reported promptly to sponsor and competent authorities as required

Q9. What is the purpose of monitoring clinical investigations as required by ISO 14155?

• To perform the sponsor’s regulatory submissions
• To ensure the rights and welfare of subjects and the accuracy and reliability of collected data
• To advertise the investigational device to potential subjects
• To manufacture additional study devices

Correct Answer: To ensure the rights and welfare of subjects and the accuracy and reliability of collected data

Q10. ISO 14155 requires documentation of source data. Which statement best describes ‘source data’?

• Only data entered into the final trial database
• Original records and certified copies necessary for reconstruction and evaluation of the clinical investigation
• Data published in journals after study completion
• Only anonymized summaries of study results

Correct Answer: Original records and certified copies necessary for reconstruction and evaluation of the clinical investigation

Q11. Which of the following is a sponsor responsibility under ISO 14155 relating to device supply?

• Ensuring investigational devices are supplied, labeled and accounted for according to the CIP
• Training the ethics committee on device manufacture
• Certifying the investigator’s personal devices for trial use
• Marketing the investigational device during the trial

Correct Answer: Ensuring investigational devices are supplied, labeled and accounted for according to the CIP

Q12. According to ISO 14155, which document should include the statistical methods and sample size justification?

• Device risk management file
• Clinical Investigation Plan (CIP)
• Investigator’s brochure
• Informed consent form

Correct Answer: Clinical Investigation Plan (CIP)

Q13. What does ISO 14155 require regarding confidentiality of subject records?

• Subject identity should be made publicly available for transparency
• Confidentiality must be maintained, and data handled in accordance with applicable privacy laws
• All records should be shared with device competitors
• Investigator may publish identifiable data without consent

Correct Answer: Confidentiality must be maintained, and data handled in accordance with applicable privacy laws

Q14. How should protocol deviations and violations be managed under ISO 14155?

• They should be ignored unless discovered by an auditor
• They should be documented, assessed for impact on subject safety and data integrity, and reported per procedures
• They must result in immediate termination of the investigator
• They should be corrected in the database without documentation

Correct Answer: They should be documented, assessed for impact on subject safety and data integrity, and reported per procedures

Q15. Which of the following best describes the role of the Investigator’s Brochure (IB) in device investigations as per ISO 14155?

• The IB outlines non-clinical and clinical information relevant to the device safety and performance
• The IB is a marketing brochure for clinicians
• The IB contains manufacturing batch records only
• The IB replaces the informed consent form

Correct Answer: The IB outlines non-clinical and clinical information relevant to the device safety and performance

Q16. ISO 14155 addresses device labeling during a clinical investigation. Which statement aligns with the standard?

• Investigational devices should be labeled to identify them as investigational and include necessary handling instructions
• Labels are not required for investigational devices
• Labels should only contain marketing claims
• Devices must be labeled with patient names

Correct Answer: Investigational devices should be labeled to identify them as investigational and include necessary handling instructions

Q17. What is the expectation of ISO 14155 regarding audits and inspections?

• Audits and inspections are prohibited during an ongoing investigation
• Investigations should be audited as necessary and sites should be prepared for regulatory inspections
• Only sponsors can perform inspections of ethics committees
• Audits should only occur after study publication

Correct Answer: Investigations should be audited as necessary and sites should be prepared for regulatory inspections

Q18. Which element is essential in the trial master file (TMF) as required by ISO 14155?

• Personal financial records of study subjects
• Documentation demonstrating compliance with the CIP and regulatory requirements
• Marketing plans for the device
• Copies of all published marketing materials

Correct Answer: Documentation demonstrating compliance with the CIP and regulatory requirements

Q19. ISO 14155 promotes integration with other standards. Which QMS standard is commonly aligned with ISO 14155 for device manufacturers?

• ISO 22000
• ISO 13485
• ISO 14001
• ISO 45001

Correct Answer: ISO 13485

Q20. For post-investigation requirements, what does ISO 14155 expect a sponsor to do after completion of a clinical investigation?

• Destroy all investigational data immediately
• Prepare a final clinical investigation report and communicate results to relevant stakeholders and authorities as applicable
• Market the device without regulatory clearance
• Withhold study results from ethics committees

Correct Answer: Prepare a final clinical investigation report and communicate results to relevant stakeholders and authorities as applicable

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