This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 324
Type: Invited
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #306197
Title: Harmonizing Data Processes with the CDISC Family of Data Standards at a Global CRO
Author(s): Steven Kirby*+ and Brad Danner and Nancy Wang
Companies: MDS Pharma Services and MDS Pharma Services and Celerion
Address: 621 Rose Street, Lincoln, NE, 68502,
Keywords: CDISC ; CDASH ; Harmonize ; SDTM ; ADaM ; CRO
Abstract:

Industry trends and client demand encouraged us (a global CRO) to better harmonize our data processes with the CDISC family of data standards: CDASH (Data Entry), SDTM (Tabulation, FDA submission), and ADaM (Analysis). Initial focus was to integrate the well established CDISC SDTM. SDTM processes had to work with data capture system; allow for accurate, efficient mapping and documentation; accommodate client preferences; and harmonize with report generation. SDTM implementation was more general, related areas were broader; need for outreach and coordination were greater than anticipated. Based on experience, the utility of harmonizing data capture and data analysis with the CDISC standards became clearer. Data flow consistent with CDISC standards was developed and implemented in stages. Experience of Global CRO will be shared with possible recommendations and take away messages.


The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2010 program




2010 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.