Abstract 
Efforts are underway to harmonize existing clinical trial and healthcare standards. What impact, if any, will this harmonization have on SAS users in clinical research?

The Clinical Data Acquisition Standards Harmonization (CDASH) initiative is a project supported by a collaborative group of organizations, and led by the Clinical Data Interchange Standards Consortium (CDISC), to harmonize data collection standards for clinical and medical research. Through the Biomedical Research Integrated Domain Group (BRIDG), CDISC is collaborating with Health Level Seven (HL7), a leading healthcare standards development organization, to harmonize the CDISC clinical research with the HL7 healthcare standards.

SAS has helped CDISC develop and implement data standards since 2000. In addition to helping define CDISC standards, SAS has also developed several products to implement the CDISC standards:

1. PROC CDISC enables organizations running SAS programs to work with
   CDISC structured data.
2. SAS Drug Development and SAS DI Studio enable organizations running SAS programs to implement CDISC standards, such as SDTM, ODM, LAB, and ADaM.

SAS XML Libname Engine reads and writes CDISC ODM file content, so any data accessible to SAS may be converted to a CDISC ODM XML document, or conversely, any content in a CDISC ODM XML document may be converted to a SAS dataset.

This paper will focus on ways in which the ongoing efforts to harmonize clinical trial and healthcare standards changes the connections and requirements among the standards and how these changes may impact SAS users in clinical research.

Bio
As a Ph.D. candidate at American University, Clinton Brownley has been a statistical consultant with the U.S. Senate HELP Committee, U.S. Department of Transportation, and D.C. Department of Motor Vehicles.

Clinton has used Base SAS and SAS/STAT to manage data and perform statistical analyses for his dissertation and the D.C. Department of Motor Vehicles. For his dissertation, Clinton uses SAS datasets to examine non-participation in the federal Earned Income Tax Credit program. For the D.C. Department of Motor Vehicles, Clinton collected and analyzed survey data using SAS datasets to evaluate the impact of a customer service improvement campaign on levels and perceptions of customer service.

Clinton is a member of the San Francisco Bay Area Chapter of the American Statistical Association (ASA) and a member of the Institute for Operations Research and the Management Sciences (INFORMS) where he is a council member with CPMS: The Practice Section of INFORMS. Clinton received his B.S. and M.S. degrees from Carnegie Mellon University.