Approaches for Preparing CDISC Compliant Clinical Data: An Experience Within a Pharmaceutical Company

• 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
• Author(s): Xiao Li*+
• Companies: Takeda Pharmaceutical Company Limited
• Keywords: CDISC ; Data standards ; STDM ; ADaM ; Alliance ; Pharmaceutical

Abstract

For a pharma company with outsourced model and alliance partners, implementing CDISC data standards and preparing submission data is a challenge. Many factors should be considered: long-term CDISC implementation strategy vs. short term submission goals, data standards of company and alliance partner. Three approaches to prepare SDTM and ADaM data discussed,(i)collect study data using non-SDTM company standard, perform analysis using non-ADaM analysis data standard, convert data to SDTM and ADaM format for submission,(ii)collect study data in non-SDTM format, produce SDTM data in parallel, produce analysis data in ADaM format, and use SDTM and ADaM data for analysis,(iii)collect data in SDTM structure construct and lock SDTM compliant database, produce analysis data in ADaM format, and SDTM and ADaM data for analysis. Will share experience and preferred strategy for CDISC implementation