**StudySAS Blog: Mastering Clinical Data Management with SAS**

CDISC Advantages CDISC has developed a set of data standards to enhance data collection, management, analysis, and reporting efficiencies, improve safety monitoring, and streamline the review and approval process for investigational treatments. Under the ICH’s electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, the FDA will mandate that all clinical trial submissions be in electronic format and that the content comply with data standards guidance. Veristat helps our clients by not only implementing these standards on a project or program, but also by providing our clients with an understanding of the CDISC standards. source:veristatinc.com   source: http://cro.businessdecision.com/ (' ’)

Results and Lessons from the CDISC SDTM/ADaM Pilot Project http://www.bettermanagement.com/seminars/seminar.aspx?mode=play&L=14684 Get registered free… and listen to 1 hour Audio seminar by… Cathy Barrows, Ph.D Chris Holland Edvard D. Helton, Ph.D Tanyss Mason Program Content: 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...