This manual highlights how DSI’s Ponemah SEND 3.1 module can be used to produce output needed for data submission to the FDA. Also attached is the Standard for Exchange of Nonclinical Data Implementation Guide version 3.1.
This document was designed to sequentially guide you through setup of the various SEND components and ultimately generating the standardized output needed for data submission. This manual references functionality that may not be fully detailed here. It may be necessary to reference additional Ponemah manuals for detailed feature information. This information can be found under the Help menu within Ponemah.
What You Will Be Learning
- Determine what functions are needed in order to generate SEND information
- Understand how to configure SEND specific features
- Generate SEND output