Page History

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

Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document (i.e., a Define-XML document) that is submitted with the data to regulatory authorities. The Define-XML standard (available at Standards for data exchange support sharing of structured metadata and data between parties and across different information systems. Standards referenced in this section support exchange of CDASH-compliant CRFs for data collection and exchange of tabulation and analysis datasets through provision of data-definition documents to describe datasets. Standards referenced in this section are supported by the CDISC Operational Data Model (ODM, available at https://www.cdisc.org/standards/data-exchange/define-xml) specifies metadata attributes to describe SDTM data.

...

odm). ODM is a vendor-neutral, platform-independent format for exchanging and archiving research data, along with their associated metadata, administrative data, reference data, and audit information.

Accessing CDASH-compliant CRFs 

The CDISC eCRF Portal (https://www.cdisc.org/

...

kb/ecrf) is a platform from which to download standard CRFs including metadata standardized per ODM. All example CRFs in Section 3.3, Product Impact on Individual Health, may be downloaded in ODM format and loaded into applicable EDC tools. Once loaded into an EDC tool, standard CRFs may then be used as-is or modified per the TIG and related CDISC standards to support needs.

CDISC Library

The CDISC Library (https://www.cdisc.org/cdisc-library) is a free community resource from which TIG v1.0 standards may be browsed, searched, and downloaded for electronic use. The Library is a cloud-based Metadata Repository (MDR) used to support efficient and controlled development, management, reuse, and electronic publication of all applicable CDISC standards. It consolidates standards within a single user interface and enables the export of standards in multiple formats for ease of implementation into software solutions. Additionally, the Library can be accessed via an API to deliver CDISC standards metadata to software applications that automate standards-based processes.

Creating Data Definition Documents to Support Data Submission

Version 2.1 of the CDISC Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml/) supports creation of data-definition files which describe the structure and contents of tabulation and analysis datasets. Define-XML documents provide

...

both a machine-readable format for use by

...

various

...

software applications and,

...

through the provision of an XSL stylesheet, a browser-based

...

rendition describing the

...

metadata attributes of tabulation and analysis datasets. The Define-XML model is implemented using extensions to the ODM-XML schema.