Module 12 2019

Data Definition Files -Define.xml

➢ All study datasets (SDTM/ADaM/SEND) require a data definition file which describes the structure and contents of the data collected during a clinical trial and is based on the CDISC Operational Data Model (ODM). ➢ It is essentially metadata about your the data sets: data that describes any tabular dataset structure and informs regulators which datasets, variables, controlled terms, and other specified metadata were used. ➢ The Data Definition Document enlists the data sets included in the submission and provides a detailed description of the contents of each data set. ➢ Define.xml file is the Data Definition Document in a machine-readable (XML) format

The Organisation for Professionals in Regulatory Affairs