Bridging Statistical Analysis Plan and ADaM Datasets and Metadata for Submission

被引：0

作者：

Li, Hal ^{[1
]}

Davidson, Jeff ^{[1
]}

机构：

[1] Octagon Res Solut Inc, 585 East Swedesford Rd, Wayne, PA 19087 USA

来源：

WORLD CONGRESS ON ENGINEERING AND COMPUTER SCIENCE, WCECS 2012, VOL II | 2012年

关键词：

Statistical Analysis Plan; STDM; ADaM; Metadata; Clinical Study Submission;

D O I：

暂无

中图分类号：

TP39 [计算机的应用];

学科分类号：

081203 ; 0835 ;

摘要：

In this article, the relationship between the Statistical Analysis Plan (SAP) and the associated ADaM Datasets is explored. An introduction to the creation of metadata based on the SAP is provided. Advice is offered regarding the key elements that a SAP must include in order to streamline the development of tables, listings and figures (TLFs) and ensure that they meet FDA guidelines. Examples are provided to demonstrate the process used for the development of ADaM datasets, metadata of longitudinal clinical trials, as well as handling of incomplete continuous clinical data.

引用

页码：1098 / 1103

页数：6