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

Friederike Seyderhelm^1,2, Ilka Krepinsky¹, Sabine Hanss¹

¹University Medical Center Göttingen, Dpt. of Medical Informatics, Germany.

Studies in Health Technology and Informatics

|May 23, 2026

Summary

This summary is machine-generated.

Open source software (OSS) presents challenges for regulatory compliance and data integrity in clinical research, particularly for non-interventional studies (NIS). This paper explores OSS validation, legal frameworks, and best practices for NIS compliance.

Keywords:

Clinical Studies Open Source Software System Validation

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Integration of Bioinformatics Approaches and Experimental Validations to Understand the Role of Notch Signaling in Ovarian Cancer

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Published on: January 12, 2020

Area of Science:

Clinical Research Informatics
Regulatory Science
Software Engineering in Healthcare

Background:

Open source software (OSS) adoption is growing in clinical research, including observational and non-interventional studies (NIS).
Limited guidance exists on ensuring OSS compliance with regulatory standards and data integrity requirements.
The regulatory landscape for studies outside frameworks like the Medical Device Regulation (MDR) presents unique challenges for OSS implementation.

Purpose of the Study:

To examine the challenges of implementing system validation for OSS platforms in clinical research.
To assess the relevance of legal, ethical, and best-practice frameworks for OSS in NIS.
To analyze the potential and limitations of OSS for maintaining data integrity and regulatory compliance in NIS.

Main Methods:

Literature review of legal, ethical, and best-practice frameworks relevant to OSS in clinical research.
Analysis of system validation requirements for OSS in the context of non-interventional studies.
Assessment of OSS suitability for data integrity and regulatory compliance in NIS.

Main Results:

Implementing system validation for OSS in clinical research faces significant challenges.
Existing legal and ethical frameworks offer partial guidance but require adaptation for OSS in NIS.
OSS offers potential benefits but also limitations regarding data integrity and regulatory adherence in NIS.

Conclusions:

OSS in NIS requires careful consideration of validation, legal, and ethical factors.
Tailored approaches are needed to leverage OSS potential while mitigating risks in non-interventional studies.
Further guidance is necessary to ensure robust data integrity and regulatory compliance when using OSS in clinical research.