Submission Documentation Efficiently
Definedoc™ contains macros and interactive tools which automate the process of documenting your electronic submission datasets. It will generate your DEFINE.PDF and DEFINE.XML files with little extra efforts. Some of the features include:
- Automatically capture all dataset 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
- 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.
Web Version Screenshots
Suite of Tools
Define Doc 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
- Definition Import
- Capture Categorical Variables for Comments
- Value Level Metadata
- Value Level Comments
- 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 visit http://www.meta-x.com/definedoc/index.html
DEFINE.XML Software, DEFINE.PDF Software, DEFINE.XML
Definedoc is software solution for: DEFINE.PDF, DEFINE.XML, DEFINE PDF, DEFINE XML, CDISC Domain Documentation, Easy Define.pdf, Quick Define.pdf, Auto Define.pdf, Automate DEFINE.PDF, Automate Define, FDA Submission, Electronic Submission, Domain Documentation, Data Definition Documentation, Data Definition.