Statistical Analysis Plan

[Jennifer Duoph <jenndu31@yahoo.com>]

Tool for Auto-Make SAP and Metadata

SapMaker is a tool developed by ClinTrialStat Inc. for making Statistical Analysis Plan (SAP) to fulfill the requirement of agencies for conducting good clinical trials. Window version of SapMaker(single license/ multiple licenses) that can create SAP and related metadata for datasets and transfer metadata to XML document, and create table shells and related SAS program template is available. Please click http://www.sapmaker.com to see a demonstration of SapMaker

Specially, users of SapMaker can automatically create metadata of Operation Data Model (ODM), Study Data Tabulate Model (SDTM), and Statistical Analysis Dataset Model (ADaM), and define.xml document following standards of Clinical Data Interchange Standards Consortium (CDISC).

SapMaker has following features:

• Automatically create SAP content text in Microsoft Word document;
• Automatically create table shells (mock tables) and mock data listing in Microsoft Word or Excel document;
• Automatically create metadata templates of datasets for the created mock table using ODM, SDTM, and ADaM standards of CDISC;
• Automatically create metadata templates of datasets customized by users;
• Allow users to work on metadata in Excel spreadsheets automatically following CDISC standards;
• Automatically transfer customer's metadata of datasets for submission to define.xml metadata document following CDISC standards;
• Automatically create SAS template of the mock table or mock data listing;
• Included all CIDSC ODM, STDM, and ADaM metadata templates of datasets and more than 300 types of mock tables;
• With capacity of managing the creation of SAP documents;
• Can be easily adapted to fit standards of customers;
• Allow SAP developer pre-view image of mock tables before creating the mock table.

If you would like more information (User's Guide, license quotation, etc., please contact us at clintrialstat@yahoo.com.

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