Registry Regulation Template

Guidance to set up registry’s purpose, structure and workflows

Registries, whether they are intended for quality control, surveillance, or research purposes require a registry regulation. It is critical to carefully assess the purpose of data collection and storage and to consider data disclosure implications respecting the rights of data subjects.

Together with several other partners, SPHN has helped develop a Registry Regulation Template. The initiative was lead by swissethics combined expertise of SPHN, the university hospital organisation unimedsuisse, the hospital association H+, the cancer research group SAKK, the Swiss Biobanking Platform,  Swiss Clinical Trial Organisation, and representatives of the university hospitals of Lausanne, Zürich, Geneva, Basel and the cantonal hospital St.Gallen.

The Registry Regulation Template serves as a comprehensive guide for anyone involved in the development of a registry designed to store and manage health-related information about individuals or populations.

Key aspects addressed in the template include the registry's purpose(s) and governance structure, operational workflows, data access and transfer protocols, quality management systems, and essential administrative details. It is in line with guiding principles for registries issued by swissethics.