Data Governance and Data Integrity as Code (DIaC) in Clinical Trials Informatics

Abstract

Data governance and data integrity are critical aspects of clinical trials informatics, ensuring the reliability and trustworthiness of clinical trial data. This paper explores the innovative concept of Data Integrity as Code (DIaC), which integrates data governance principles into the software development lifecycle of clinical trials informatics systems. DIaC emphasizes the proactive management of data quality and integrity by automating data governance practices through code. This approach enhances data quality, reduces compliance risks, and accelerates the development and deployment of clinical trials informatics solutions. This paper presents an overview of DIaC, its benefits, challenges, and practical implementation considerations in the context of clinical trials informatics.