CDISC Standards Implementation from Study Protocol to Statistical Reporting: Finding a Practical Solution

• 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): Fima Gershteyn*+ and Yun Oldshue
• Companies: Takeda Global R&D and Takeda Global R&D
• Keywords: CDISC standards ; implementation options ; transition preparation

Abstract

As CDISC standards are gaining acceptance in the pharmaceutical industry and within the FDA, defining strategy and operational plans for standards implementation becomes important. Ideally, the complete implementation of the standards from the study protocol to the data used in statistical analysis and reporting might be the best option for a pharmaceutical company. However, this may not be practical due to a large magnitude of changes from established standards, processes and tools, various degrees of maturity for particular CDISC standards, and operational efficiency considerations. A more pragmatic approach using CDISC-based (but not exact) standards can allow preserving operational efficiencies while facilitating preparation of final CDISC-compliant submission data. This approach, along with other possible options, is described. Also, the experience planning the transition from proprietary company standards to CDISC-based standards is discussed.