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