Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.

Abstract

Open source software (OSS) is increasingly used in clinical research, including observational and non-interventional studies (NIS), yet guidance on compliance with regulatory and data integrity standards remains limited. This paper examines the challenges of implementing system validation for OSS platforms, highlighting the unique regulatory environment for studies outside statutory frameworks such as e.g. the Medical Device Regulation (MDR). We provide an overview on legal, ethical, and best-pr