What is SapMaker?                                 

SapMaker is a tool for helping users efficiently make Statistical Analysis Plans (SAP) for clinical trials.  It will provide you easily-to-use features to efficiently create Word document of SAP with table and figures shells, SAS programs of the tables, and metadata document of analysis datasets.

Who should use SapMaker?

Biostatisticians, Statistical Programmers, and Medical Writers who are working on clinical trials.

If you are a biostatistician working at a pharmaceutical or biotechnique company, this is a must have tool for you.

Major Features

• Provide instructions for writing contents of Statistical Analysis Plan (SAP), Clinical Study Report (CSR), and Clinical Study Protocol.

• Write selected sections of the SAP, CSR, and Protocol into a Microsoft Word document;

• Provide “search-engine” utility for the author to retrieve relative paragraphs associated to the topic of the section from other study specified Word documents such as Study Protocol.

• Can use this tool to quickly create table shells (mock tables) in a Microsoft Word or Excel document, and mock figures in a Word document.

• Include a easy-to-use editor to modify or develop templates for SAP/CSR/Protocol contents, SAP mock tables and figures.

• Can use this tool quickly create SAS code to generate the table by using an easy-to-use editor to extract metadata of the template of to develop SAS codes calling specified SAS macros

• Can use this tool quickly create metadata document following the standards of the Clinical Data Interchange Standards Consortium (CDISC) included Operation Data Model (ODM), Study Data Tabulate Model (SDTM), and Statistical Analysis Dataset Model (ADaM)

• Can create SAS program template for creating a dataset based on the metadata document (in an Excel document).

• Can transfer metadata document to define.XML document following CDISC standards.

Requirement

• Supported Operating Systems: Microsoft Windows 9X/NT/2000/XP (Window 9X/NT/2000 need updated with Microsoft NET. Framework 1.1 or 2.0)

• Software Requirements:  Microsoft Word or Microsoft Excel.