Implementing CDISC Based Processes: General Solutions for Common Challenges: Building Define.xml Data Documentation into the SDTM/ADaM Mapping Process
Presenters: Luke Reinbolt (Pharmanet i3), Steve Kirby (ViroPharma) and Mario Widel (Roche Molecular)
Wednesday, January 11, 2012, 3:00 p.m. to 5:00 p.m. Eastern time
Registration Deadline: Monday, January 9
Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly central to the drug development process and are the default standard for use when submitting tabulations (CDISC SDTM) or analysis (CDISC ADaM) data to the FDA. Sponsors are expected to submit define.xml data documentation with all CDISC applications to the FDA. Well formed data contains all information needed to understand study results, but that information is typically not easily accessible to end users; combining the data with xml format data documentation gives end-users a data and documentation package that is complete and user-friendly.
Define.xml data documentation helps the data say "Hello" to reviewers and other downstream users with internal and external links to the level of information needed, from source CRF references to variable lists to code lists and comments associated with key content. Integrating the information needed to support the define.xml into the process of preparing to convert source data to SDTM format or SDTM to "analyzable" ADaM emphasizes the documentation needed to support submission data and allows the define.xml to be generated to support use and review of the data at each stage, from test transfer to final submission. Starting with the core levels of information (from study and variable characteristics to code lists) needed to support submission data, the presenters share practical ways to build the information needed for the define.xml into the mapping process and leverage the data and the mapping specs to create the define.xml.
This presentation is designed for people and groups with a solid functional understanding of data definition documents (define.pdf or define.xml) and data mapping specifications. This is part four of a four part series that started with "From Source to SDTM," "From SDTM to 'Analyzable' ADaM, " and "From ADaM to Tables and Figures."