Abstract #300317

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JSM 2003 Abstract #300317
Activity Number: 256
Type: Luncheons
Date/Time: Tuesday, August 5, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300317
Title: Electronic Submissions, Data Standards, Data Warehouses, and Analysis Databases - THIS LUNCHEON IS SOLD OUT
Author(s): Stephen Wilson*+
Companies: Food and Drug Administration
Address: 5600 Fishers Ln. Rm 18B-45, Rockville, MD, 20857-0001,
Keywords: electronic submissions ; analysis databases ; data standards ; NDA ; HL7 ; regulatory guidance
Abstract:

With regulation in 1997 (21 CFR 11) and guidance in 1999 (Guidance for Industry: Providing Regulatory Submissions in Electronic Format--NDAs) the FDA established a path for the official submission of archival, electronic files (documents and data) for regulatory review. The Center for Drug Evaluation and Research currently plans to update its submission guidance and, working through HL7, to standardize clinical trial data elements. These efforts to improve electronic submission guidance will have an impact on the work of industry statisticians. This will be an opportunity to discuss these evolving standards and to think about best practices in the documentation of analyses and the creation of submission data files.

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Revised March 2003