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The CDISC Define.xml Checker

The Case Report Tabulation Data Definition Standard (CRT-DDS), better know as define.xml is one of the newer standards of CDISC, and one of the most important, as it the first of a small series for submissions to the FDA in CDISC XML format.
The CDISC Define.xml Checker is a validation software package to validate your define.xml files against the standard and for internal consistency.
As such, it is an indispensable software package for every sponsor (or submission service provider) that is submitting information to the FDA using the define.xml standard.

The CDISC Define.xml Checker accepts a define.xml file as input and validates it against the define.xml XML-Schema. At the same time, checking is performed all other rules that have been defined in the standards document.
Furthermore checking is performed for internal consistency (reference - definition mechanism). Finally, it is checked whether all referenced external PDF and SAS Transport V files are present at the given location.

Features

• Clear error messages, understandable for non-XML specialists
• Validation far beyond classic validation against the XML-Schema
• Checking for internal consistency (e.g. ref-def mechanism)
• Checking for presence of all referenced external files
• Printable checking report
• Checking report can be saved to file
• Very user-friendly: file drag-and-drop

Download

Download a sample checking report

Pricing

Single PC-license (perpetual license): US$ 1,500 / € 1,000

How to order

• By purchase order from your organisation
• Per e-mail with Credit Card payment (Mastercard, Visa, Amex)

XML4Pharma, Schlossbergstr. 20, 78224 Singen, Germany. Phone: +49 7731 975044