Developing and Promoting Data Standards for Clinical Research

This chapter describes the importance of data standards in clinical research, particularly for streamlining regulatory oversight and enabling research that is conducted using electronic health record systems in “real-world settings.” Standards are needed to exchange data between partners with preserved meaning and to enable accurate analytics, a core aim of research. There are different types of standards and numerous organizations – national, international, and global – that develop them. The coordination and harmonization of these efforts will be necessary to fully realize an efficient clinical research system that is synergistic with healthcare systems in the USA and abroad. We highlight important collaborations that are influencing the development and use of clinical and research standards to solve significant and outstanding scientific, societal, and business challenges of biomedical research and population health.