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Make Open Source Compliant: Validation in Non-Interventional Clinical Studies
Friederike Seyderhelm1,2, Ilka Krepinsky1, Sabine Hanss1
1University Medical Center Göttingen, Dpt. of Medical Informatics, Germany.
None:
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-practice frameworks and assess their relevance for OSS in NIS. Our analysis demonstrates both the potential and limitations of open source solutions for maintaining data integrity and regulatory compliance in non-interventional clinical research.
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