Data Management Framework

Developing a data management framework for a clinical research institution

Ho Van Hien, Oxford University Clinical Research Unit

5^th November 2024

In the rapidly evolving field of clinical research, the effective management of data is paramount. A robust data management framework is essential for ensuring the integrity, security, and accessibility of data throughout the research lifecycle. This framework not only supports compliance with regulatory requirements but also enhances the efficiency and reliability of research outcomes.

Developing a data management framework for a clinical research institution involves a comprehensive approach that integrates best practices in data collection, storage, processing, and analysis. It requires a thorough understanding of the unique challenges and needs of clinical research, including the handling of sensitive patient information, adherence to ethical standards, and the facilitation of collaborative research efforts.

This framework introduces sets the stage for exploring the key components and strategies involved in creating an effective data management framework, highlighting its critical role in advancing clinical research and improving quality of research data throughout comprehensive data management processes. This is the result of a long-journey of studying the SCDM’s Good Clinical Data Management Practices (GCDMP©) (SCDM, 2013), ICH E6 (R2) Good clinical practice (ICH) and practical experiences of Data Managers of the Oxford University Clinical Research Unit.

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