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Abstract Details

Activity Number: 346
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #305747
Title: Metadata and Adam
Author(s): Kevin Lee*+
Companies: Cytel Inc.
Address: 904 Herman Rd, Horsham, PA, 19044, United States
Keywords: CDISC ; metadata ; ADaM ; Survival ; ADTTE ; Clinical Trial

The presentation is intended for statisticians and Clinical Trial SASĀ® programmers who are interested in applying ADaM metadata to clinical trial process. The presentation will show the flow of clinical trial process and how metadata will be used in the process. ADaM introduces four metadata - analysis dataset metadata, analysis variable metadata, analysis parameter value-level metadata and analysis results metadata. The presentation will show how to create each metadata from Mock Up tables. I will also show how to apply the metadata to clinical trial study process such as ADaM datasets and efficacy analysis. It will also discuss the pros and cons of creating metadata before ADaM datasets and analysis. The presentation will be based on survival analysis, so it will introduce ADaM time to event data structure(ADTTE).

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