ISO 14155:2026 was finally published in April 2026 with immediate effect which means that any new study that is started should comply with its requirements. For ongoing studies it is usually tolerated to keep going under the previous version based on risk management decisions. What does this mean? In practice, if a standard brings important changes based on risk management to protect patients rights, well-being or protection or contributes significantly to the scientific outcome of the study, the changes should be taken into consideration for implementation. This may result in , no need for changes at all as the company already applied sufficient requirements, or modifications while performing a planned protocol amendment, or modifications in the quality management system or immediate protocol amendments to achieve the objectives of new compliance.