8/04/2020

The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable to clinical research. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in global clinical research is ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice. ISO 14155 has been updated to the third edition and released in July 2020. Important changes to modernize the standard include:

Inclusion of a summary of Good Clinical Practice (GCP) principles in alignment with ICH E6(R2) GCP
Guidance for clinical quality management, ethics committees, and audits
Addition of risk-based monitoring closer in alignment with ICH E6(R2) and FDA’s guidance on A Risk-based Approach to Monitoring
Strengthened guidance for risk management throughout the clinical investigation linked with ISO 14971 2019: Medical devices — Application of risk management to medical devices
Added reference to registering clinical trials in a public database
Clarification for how the standard is applicable to the different stages of clinical development
Discussion of registration of clinical investigations in a public database

ISO 14155 address GCP for medical device studies including the design, conduct, recording, and reporting of clinical investigations. The third edition of ISO 14155 strengthens risk management requirements across all phases of the clinical investigation process, including pre- and post-market clinical investigations. Some regulatory bodies or companies may require following the standard, but even when it is not required, following ISO standards supports a quality medical device clinical trial.

Do you currently work on a project where ISO 14155: 2011 is applicable? Training is a requirement for the standard.
Need training on the differences between the versions for your teams? Need training on the full 14155:2020 standard?
Concerned your quality system will not meet the new requirements for risk management?
Clinical Pathways offers consulting services and training customized to fit your company’s requirements and training needs.

Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 35 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 15 years as a CCRA and CCRC. She is a current ACRP Fellow, which is awarded to individuals who have made substantial contributions to the Association and the industry at large. She is a frequent speaker at industry conferences and has authored 100’s of courses for clinical research training programs in various functional areas. She has auditing, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. In 2002 she co-founded Clinical Pathways (CP), LLC with Charles "Chuck" Sather.

- The Clinical Pathways Team

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