| Publisher | SAS Institute | ||
|---|---|---|---|
| Format | Webcast | Date added | 25 Feb 2008 |
| Topics | Knowledge and Data Management | ||
| Downloads | 1 | ||
The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated metadata met the needs and the expectations of both medical and statistical FDA reviewers. In doing this, the project also assessed the data structure, resources and processes needed to transform data from a data source into the SDTM and ADaM formats, and to create the associated metadata. An additional goal was to produce a worked example implementation of the CDISC standards available at that time, including the Define.xml file. This webcast will review the experiences, results, and learnings of the pilot project core team regarding the creation of a CDISC-adherent submission.
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