Evaluation of the Programmers/Statisticians Role with CDISC - a CRO Perspective

• Activity Number: 559 - CDISC Standards Usage and the Role of Biostatisticians and Programmers
• Type: Invited
• Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): William Coar*
• Companies: Axio Research
• Keywords: CDISC ; CRO ; SAS Programmer ; Statistician ; Statistical Programmer

Abstract

Implementing CDISC standards for use on day-to-day activities throughout the course of drug development is inherently challenging. It typically involves much interaction between SAS programmers, statisticians, and data management. Standardization within an organization can assist in easing those interactions, but this is often easier said than done. In a CRO environment, data of comes in many different shapes and sizes especially if EDC system and CRF design is not consistent from Sponsor to Sponsor. This makes implementation of CDISC standards more challenging. Statisticians and programmers need to find a balance between standards within the CRO as well as following standards required by a Sponsor company yet remain CDISC complaint even though it may not be necessary. This presentation is intended to generate much needed discussion among statisticians and programmers to establish roles, responsibilities, expectations, and efficiencies when it comes to implementing CDISC in a CRO setting.