Facilitating Communication About Analysis Data Needs Across Functional Areas

• Activity Number: 265
• Type: Roundtables
• Date/Time: Tuesday, August 3, 2010 : 7:00 AM to 8:15 AM
• Sponsor: Section on Statistical Computing
• Author(s): Steven Kirby*+
• Companies: MDS Pharma Services
• Keywords: ADaM ; SAP ; SDTM ; CDISC ; Analysis Data ; Trial Design Data

Abstract

Data Collection, Data Programming and Data Analysis often are done by separate groups that look at and refer to data very differently. Statisticians often refer to data based on the type of analysis needed; data programmers often view data in terms structural details; and people collecting the data tend to focus on the substance of component parts of the data. Communicating analysis needs across those functional areas can be challenging and time-consuming. Formal approaches such as generation of analysis plans and specific or general data specifications are often effective but burdensome; informal methods such as discussion and iterative review are versatile but hard to put on a schedule. The discussion will center on formal and informal options that have been successfully (or unsuccessfully) used to streamline communication about analysis data needs.