Identifying and Reducing Risk Factors for CDISC-Compliant Submissions: How It Affects Programmers

• Activity Number: 366
• Type: Roundtables
• Date/Time: Tuesday, August 3, 2010 : 12:30 PM to 1:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Rachna Mittal*+ and Todd Case
• Companies: Genentech and Bristol-Myers Squibb
• Keywords: CDISC ; roundtable ; submission

Abstract

CDISC-compliant submissions are becoming more and more prevalent. However, the decision to outsource CDISC as well as the timing at which proprietary data is converted into CDISC format could potentially vary depending on many factors, among which include the knowledge-base of full-time employees within a company and the amount of time and full-time resources a company can contribute to CDISC activities. The purpose of this round-table is to informally discuss and share general and non-proprietary experiences with outsourcing CDISC submissions as well as to share experiences among discussants regarding lessons learned and best practices regarding this process. Another purpose is for the session to serve as a meeting for which all interested parties can meet, cover some specific topics and learn from each other.