ISO 14155:2020 – a guide to good clinical practice for medical device clinical investigations

ISO 14155:2020 is an international standard that outlines Good Clinical Practice (GCP) requirements for clinical investigations of medical devices in human subjects. It ensures the ethical, scientific, and regulatory integrity of such studies, providing guidance for sponsors, investigators, ethics committees, and regulatory authorities.

Key elements of ISO 14155:2020

1. Scope (clause 1)

• Covers clinical investigations designed to assess the clinical performance, safety, and effectiveness of medical devices.
• Ensures compliance with ethical principles, particularly those outlined in the Declaration of Helsinki.
• Applicable to both pre-market and post-market clinical investigations.

2. Good clinical practice (GCP) principles (clause 4)

• Protection of the rights, safety, and well-being of human subjects.
• Scientific validity and reliability of clinical investigation data.
• Ethical approvals and regulatory compliance before study initiation.
• Informed consent of participants.
• Proper documentation, data recording, monitoring, and auditing.

3. Ethical considerations (clause 5)

• Avoidance of improper influence or coercion.
• Compensation for participants should not create undue inducement.
• Requirement for registration of clinical investigations in a publicly accessible database.
• Special considerations for vulnerable populations (e.g., children, unconscious patients).
• Clear informed consent process, including signature requirements and updates based on new information.

4. Clinical investigation planning (clause 6)

• Risk management and benefit-risk assessment aligned with ISO 14971.
• Justification of the clinical study design.
• Development of a Clinical Investigation Plan (CIP).
• Creation of an Investigator’s Brochure (IB) detailing the investigational device.
• Selection of investigation sites and monitoring plans.
• Requirements for case report forms (CRFs).

5. Clinical investigation conduct (clause 7)

• Study initiation, monitoring, and documentation.
• Recording and reporting of adverse events and device deficiencies.
• Confidentiality and data privacy protections.
• Accountability for investigational devices to ensure traceability and integrity.

6. Safety and risk management (clause 7.4)

• Adverse Event (AE): Any untoward medical occurrence in a study participant.
• Serious Adverse Event (SAE): Life-threatening event, hospitalization, disability, or death.
• Adverse Device Effect (ADE): Adverse event related to device use.
• Serious Adverse Device Effect (SADE): A device-related event leading to serious harm.
• Unanticipated SADE (USADE): Unexpected and serious device-related events.

7. Suspension, termination, and reporting (clause 8)

• Procedures for early termination or suspension of investigations due to safety concerns.
• Clinical Investigation Reports and risk assessment conclusions after study completion.
• Data retention and auditing requirements.

8. Responsibilities of the sponsor (clause 9)

• Selection and training of investigators.
• Conducting safety evaluations and reporting to authorities.
• Implementing clinical quality management and risk-based monitoring.
• Communicating with regulatory bodies.

9. Responsibilities of the principal investigator (clause 10)

• Ensuring compliance with the CIP and GCP principles.
• Obtaining ethics committee approval.
• Managing the informed consent process.
• Reporting adverse events and device deficiencies.
• Providing medical oversight for study subjects.

Annexes

• Annex A: Detailed requirements for a Clinical Investigation Plan (CIP).
• Annex B: Contents of an Investigator’s Brochure (IB).
• Annex C: Guidance on Case Report Forms (CRFs).
• Annex D: Clinical Investigation Report format.
• Annex E: Essential clinical investigation documents.
• Annex F: Categorization of adverse events.
• Annex G: Guidance for Ethics Committees.
• Annex H: Application of ISO 14971 risk management to clinical investigations.
• Annex I: Clinical development stages.
• Annex J: Clinical investigation audit guidance.

Summary

ISO 14155:2020 sets the global gold standard for conducting clinical investigations of medical devices. It ensures that studies are ethically sound, scientifically valid, and regulatory compliant while prioritizing patient safety and data integrity. It aligns with ISO 14971 for risk management and provides comprehensive guidelines for sponsors, investigators, and ethics committees.