Abstract
The Clinical Data Interchange Standards Consortium (CDISC) has developed standards for data models, study design, and supporting clinical trial documents. CDISC standards have made such gains that the Center for Drug Evaluation and Research strongly encourages their use and implementation for submission of drug applications. However, despite the advances and improvements in these standards over the years and the ever-looming threat that they may someday be a requirement for drug applications, many are skeptical of a single standard and fail to understand the far-reaching advantages of adopting it. In this article we address the concerns and present numerous tangible benefits of CDISC standards.
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References
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Zink, R.C., Mann, G. On the Importance of a Single Data Standard. Ther Innov Regul Sci 46, 362–367 (2012). https://doi.org/10.1177/0092861512441101
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DOI: https://doi.org/10.1177/0092861512441101