What is BS EN ISO 14155:2019?

BS EN ISO 14155:2019 is a standard that provides guidance on the design, conduct, recording, and reporting of clinical investigations carried out in human subjects for medical devices. It sets out the essential principles and procedures to ensure the protection of participants' rights, safety, and well-being.

Importance of BS EN ISO 14155:2019

This standard plays a vital role in ensuring the reliability and credibility of clinical investigations. It sets forth specific requirements for the ethical conduct of studies involving medical devices, helping to establish a framework for good clinical practice (GCP).

By adhering to BS EN ISO 14155:2019, manufacturers and researchers can enhance patient safety and improve the quality of data generated during clinical investigations. Compliance with this standard ensures that studies follow strict protocols and guidelines, reducing the risk of errors or bias in results.

Key Elements of BS EN ISO 14155:2019

The standard covers various aspects of clinical investigations, including study design, participant selection, informed consent, and data management. Here are some key elements:

Protocol Development: BS EN ISO 14155:2019 emphasizes the importance of a well-defined protocol that outlines the objectives, methodology, and statistical considerations of the study. This helps to ensure that the investigation is conducted in a systematic and reliable manner.

Risk Assessment and Management: The standard requires sponsors and investigators to conduct a thorough risk assessment before initiating a clinical investigation. Strategies should be in place to minimize potential harms and manage any adverse events that may occur during the study.

Informed Consent: BS EN ISO 14155:2019 emphasizes the need for informed consent procedures that provide participants with clear and understandable information about the study, its risks, benefits, and alternatives. Participants must have the freedom to decide whether or not to participate in the investigation.

Data Integrity: The standard highlights the importance of accurate and reliable data collection, management, and analysis. Sponsor responsibilities include ensuring data privacy, confidentiality, and quality throughout the study.

Conclusion

BS EN ISO 14155:2019 plays a crucial role in ensuring the ethical conduct of clinical investigations involving medical devices. Compliance with this standard promotes participant safety, enhances data reliability, and protects the rights and well-being of human subjects. By following the guidance provided by BS EN ISO 14155:2019, manufacturers and researchers can contribute to the advancement of medical knowledge and innovation while upholding the highest standards of patient care.