Submission Documentation Efficiently
Definedoc contains macros and interactive tools which automate the process of documenting your electronic submission datasets. It will generate your DEFINE.XML/PDF files with little extra efforts. Some of the features include:

• Generate DEFINE.XML/PDF with automated capture of data and variable attributes (i.e. PROC CONTENTS) for SAS datasets being submitted.

• Automated identification of key fields through sort order of datasets.
• Decode all coded lists through a format catalog decoder algorithm.
• Intelligent defaults of the origins of each variable by identifying matches to variables in source datasets and variables in analysis datasets.
• User friendly spreadsheet editor for updates after automated variables are captured
• Annotated CRFs are automated with dataset and variable names created without having to manually enter avoiding typos
• Audit trail of edits and updates are made for change control of documentation.
• Reports are generated for DEFINE.PDF and DEFINE.XML or in Excel or WORD format.
• Desktop screen examples...
• Web version screen examples...
• Definedoc Features compared to SAS Clinical Toolkit

Service
Our Definedoc service can generate your DEFINE.XML or PDF file from input data starting at $9.99 per dataset.  Upload a ZIP file of your SAS Transport file and try it out here...

Video Overview

1. Optimize and Automate Capture of Metadata
   
     
      

2. Update Documentation to Reflect Changes to Data
   
      
      

3. Excel Export and Import for Flexible Editing
   
     
     
   

4. Generate both DEFINE.PDF and DEFINE.XML
   
      

Suite of Tools
CDISC Builder is part of a suite of tools which can be implemented to provide data for your submission that is compliance to regulatory requirements. This automate the process and delivers data with greater accuracy and integrity

Sy/Validate Transdata CDISC Builder Define doc

Published Papers related to Definedoc

• PharmaSUG 2007: " CDISC Implementation Step by Step: A Real World Example "
• PharmaSUG 2006: "Cost Effective Ways to Generate DEFINE.PDF & DEFINE.XML"
• Western Users of SAS Software 2005: " Data Integrity through DEFINE.PDF and DEFINE.XML "

For more information, please contact MXI .