CDISC SDTM Implementation Real World Application

Training

CDISC SDTM Implementation Real World Application

Course Introduction
Implementation of the CDISC data models is no longer a theoretical academic exercise but is now entering the real world. This course will walk you through the lessons learned from implementations of CDISC SDTM version 3.1.1 and ADaM 2.0. It will cover both technical challenges along with methodologies and processes.

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
Some of the topics covered in the course include:

Project Definition, Plan and Management
Data Standard Analysis and Review
Data Transformation Specification and Definition
Performing Data Transformation to Standards
Review and Validation of Transformations and Standards
Domain Documentation for DEFINE.PDF and DEFINE.XML

The regulatory requirements are going to include CDISC in the near future and the benefits are obvious. It is therefore wise and prudent to implement with techniques and processes refined from lessons learned based on real life implementations.

Course Overview

CDISC standards have been in development for many years. There have been structural changes to the recommended standards going forward from version 2 to 3. It is still an evolving process but it has reached a point of critical mass that organizations are recognizing the benefits of taking the proposed standard data model out of the theoretical and putting it into real life applications. The complexity of clinical data coupled with technologies involved can make implementation of a new standard challenging. This paper will explore the pitfalls and present methodologies and technologies that would make the transformation of nonstandard data into CDISC efficient and accurate.

It is important to have a clear vision of the processes for the project before you start. This provides the ability to resource and plan for all the processes. This is an important step since the projects can push deadlines and break budgets due to the resource intensive nature of this effort. The organization and planning for this undertaking can become an essential first step towards an effective implementation.