Clinical Data Interchange Standards Consortium (CDISC) is an open, non-profit organization that develops and supports global data standards to improve the quality and interoperability of medical research and healthcare.CDISC standards are widely used for study planning and data collection, tabulation, analysis, and submissions to the US Food and Drug Administration (FDA) and other regulatory agencies internationally.Each observation can be described by a series of variables, corresponding to a row in a dataset or table.
Eventually, all data submissions will be expected to conform to this format.
As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management.
SDTM is built around the concept of observations collected about subjects who participated in a clinical study.
A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used.
Variables can be classified into four major roles: A fifth type of variable role, Rule, can express an algorithm or executable method to define start, end, or looping conditions in the Trial Design model.