CDISC Standards Implementation: A Status Check

• Activity Number: 60
• Type: Topic Contributed
• Date/Time: Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Dan Crawford*+
• Companies: Octagon Research Solutions, Inc.
• Keywords: CDISC ; ADaM ; Standards ; SDTM ; CDASH

Abstract

The presentation will cover an update on the current status of CDASH, SDTM, ADaM and introduction to Protocol Representation Model (PRM). The recently released CDASH User Guide V1.0 and Implementation Guide V 1.1 will be examined including changes and enhancements since the last release.SDTM Version 3.1.2 will be explored. The resulting data from the clinical trial will also be discussed and how these up front standards enable an easier transition into the ADaM standard for programming and statistical analysis. The discussion will focus on the How, When and Why to implement each standard and how implementing these standards earlier in the process enables companies to work "smarter" and not "harder". In addition, the implementation of standards as well as the concept of Standards Governance and what is needed in order to accomplish this within your organization will be discussed. The Protocol Representation Model will also be examined including what the model is, its relationship to SDTM and BRIDG and how it can be used in the future to benefit all those who work on/participate in Clinical Trials.