CDISC ODM Implementation - Operational Data Model

Training

CDISC ODM Implementation Operational Data Model

Course Introduction
This course will describe implementation use cases of the CDISC ODM. It will teach the basics of XML and expand on how that is implemented in the operational data models. The use cases will include exchanging data, archival and electronic submission to regulatory agencies such as a FDA submission.

About Instructor
Sy Truong is the cofounder and president of MXI (Meta-Xceed, Inc.) since 1997. MXI provides software solutions within the Pharmaceutical Industry specializing in CDISC data standards, SAS validation, electronic submission, data analysis and reporting. Sy is one of the committee members of the Bay Area SAS User Group (www.basas.com). He is a frequent contributor and presenter at PharmaSUG, WUSS, and SUGI conferences. He's currently writing a book for SAS Publishing entitled Becoming a SAS Clinical Trials Programmer.

Course Information
The ODM is one of the first data models established by CDISC and has become the standard structure which many other data models inherit and expand upon. Other related models include SDTM, ADaM and DEFINE.XML. This course will give you a foundation on the ODM and how it can be used for data transportation between collaborators such as CRO and also electronic submission to regulatory organization such as the FDA. It will deal with archival techniques and other related metadata management to become fully compliant.

SAS Cluster SAS Grid Cluster SAS Grid SAS SAS Cluster System SAS Cl