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eCRF Portal and ODM-XML

Define-XML

The CDISC Define-XML Model supports creation of data definition files with which to describe tabulation and analysis datasets. 

is to describe CDISC Study Data Tabulation Model (SDTM), 
Standard for Exchange of Nonclinical Data (SEND), and Analysis Data Model (ADaM) datasets for the purpose of 
submissions to regulatory authorities. However, Define-XML also serves as a metadata exchange mechanism for 
other parties seeking to exchange CDISC-modeled dataset structures as well as proprietary (non-CDISC) dataset 
structures. For dataset structures modeled following CDISC standards, refer to the SDTM, ADaM, and SEND 
Implementation Guides (IG); see Section 2.2, References.
The intent is to comply fully with all applicable regulations and guidance. This document includes 
substantially all of the material from the Define-XML v2.0 specification in addition to Define-XML v2.1 changes 
that include an updated approach to def:Origin, versioning of standards and controlled terminology, improved 
SENDIG support, v2.0 errata fixes, and additional updates (see Section 1.1.3, Relationship to Prior Define-XML 
Specifications).
Define-XML v.1.0 described the requirements for constructing Define-XML documents to replace the define.pdf 
documents recommended in the FDA’s 1999 Regulatory Submissions in Electronic Format, General Considerations
guidance (see Section 2.2, References). Since that time, Define-XML documents have proven to be a useful 
mechanism for transmitting case report tabulation (CRT) metadata. One of the key benefits to FDA reviewers is that 
this format provides both a machine-readable format for use by the various FDA software applications and, through 
the provision of an XSL stylesheet, a browser-based report describing the contents of a stud

SDTM 2.2 Datasets and Domains

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