FDA Adds CDISC
ODM Define.xml to Study Data Specifications
The FDA has now included the CDISC Case Report
Tabulation Data Definition Specification (define.xml),
which is based on the CDISC ODM, as part of
the eCTD Study Data Specifications for the eCTD
for submissions using the SDTM. The revised
specifications are available at http://www.fda.gov/cder/regulatory/ersr/ectd.htm.
(posted 7/13/2005)
Case Report Tabulation Data Definition Specification
(CRT-DDS, also called define.xml)
Final Version 1.0
CRT-DDS
Released for Implementation February 10, 2005.
The CDISC define.xml
Team has published the Case Report Tabulation
Data Definition Specification (define.xml) Version
1.0 for implementation, which supersedes all
prior versions. Version 1.0 reflects changes
from a comment period through the Health Level
7 (HL7) Regulated Clinical Research Information
Management Technical Committee (RCRIM) in December
2003 (www.hl7.org) and CDISC's website in September
2004 as well as the work done by the define.xml
team in conjunction with the CDISC ODM team
to add functionality, features, and additional
documentation.
This document specifies the standard for providing
Case Report Tabulations Data Definitions in
an XML format for submission to regulatory authorities
(e.g., FDA). The XML schema used to define the
expected structure for these XML files is based
on an extension to the CDISC Operational Data
Model (ODM).
The 1999 FDA
electronic submission (eSub) guidance and the
electronic Common Technical Document (eCTD)
documents specify that a document describing
the content and structure of the included data
should be provided within a submission. This
document is known as the Data Definition Document
(e.g., "define.pdf" in the 1999 guidance).
The Data Definition Document provides a list
of the datasets included in the submission along
with a detailed description of the contents
of each dataset. To increase the level of automation
and improve the efficiency of the Regulatory
Review process, define.xml can be used to provide
the Data Definition Document in a machine-readable
format.
Please post
any comments, questions or suggestions to CDISC's
Public
Discussion Forum.
| Filename |
Description |
CRT_DDSpecification1_0_0.pdf
|
Case Report Tabulation
Data Definition Specification (define.xml),
Version 1.0. |
| define1-0-0.xsd |
The define.xml schema version
1.0.
This schema “glues” the extensions
and the ODM together to create the full
define.xml definition.
Applications implementing define.xml should
reference only the define1-0-0.xsd directly. |
| define-extension.xsd |
This schema defines where
in the ODM the define.xml extensions should
appear. |
| define-ns.xsd |
This schema defines the elements
and attributes that are included in the
define.xml extensions to ODM. |
| SchemaFiles.zip |
A ZIP file that includes
all of the schema related files only (define1-0-0.xsd,
define-extension.xsd, and define-ns.xsd). |
| define1-0-0.xsl |
An initial define.xml style sheet (Version
1.0) that is compliant with XSLT Version
1.0 specification (1999). Future releases
of the style sheet will expand the available
functionality and features. |
| Example
1: define.xml |
An example of the data definition
document in XML without a style sheet reference. |
| Example
2: define.xml |
An example of the data definition document
in XML with a style sheet reference. |
| ExampleFiles.zip |
A ZIP file that includes both examples,
including all referenced external files
for the 2nd define.xml example (e.g., define1-0-0.xsl,
sample SAS Version 5 Transport Files, blankcrf.pdf,
and supplementaldatadefinitions.pdf). |
| CRT_DataDefinitionFiles.zip |
A ZIP file that contains
all of the files referenced above (excluding
the above zip files). |
| To insure the latest copy of the define.xml specifications
and supporting materials, users should 1)
check the CDISC website for news related
to new versions of the define.xml specifications,
style sheet or support documentation, and
2) compare the website posting date with
their file download date and update when
necessary |
Go
to CDISC Public Discussion Forums
|
