We frequently give this presentation to new clients, to let them know what to expect when planning a submission. Topics of this conversation include: Strategy and planning Specifying project deliverables Production and QC of analysis datasets and TFLs Evaluation of project deliverables Assembling and auditing the data submission Fielding FDA requests 120 Day Safety… Read more »
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Intro to Define.xml 2.0
This presentation de-mystifies the Define.xml 2.0 documentation standard by: Introducing the new features in Define.xml 2.0 with examples of familiar problems they solve Comparing display-formatted documentation from 2.0 with1.0 for a variety of use cases Pointing out challenges in collecting metadata content for the new features Discussing methods for managing user-editable content
Lumping and Splitting: Using Graphics Building Blocks with SAS ODS Statistical Graphics
The ODS Statistical Graphics package contains a powerful set of graphical elements. One especially useful feature of this package is the way that these elements can be combined. With small changes in syntax, one can present several different kinds of information on a single graph, or use a layout as a prototype for a set… Read more »
Creating Define.pdf with SAS® Version 9.3 ODS RTF
It is becoming more common for regulatory submissions to include define.xml – the data definition documents for Study Data Tabulations Model (SDTM) data, Analysis Data Model (ADaM) data, and even legacy data. Although define.xml documents can help regulatory reviewers to navigate submission datasets, documents and variable derivations, they usually do not print out properly on… Read more »
The CDER Common Data Standards Issues Document and the SDTM/ADaM Impact
This presentation discusses the Common Data Standards Issues Document issued by CDER which describes reviewer’s experience with submitted SDTM data , recommendations for standard data preparation, and the impact of the recommendation on SDTM and ADaM preparation.
Making a List, Checking it Twice: Efficient Production and Verification of Tables and Figures Using SAS®
In the CDISC era, biotechnology and pharmaceutical companies are paying increasing attention to how analysis dataset specifications are documented and accuracy of datasets that are generated. It has always been a desirable practice to record the details about analysis datasets, including the structure of the dataset, the source of data variables, the logic of derivations,… Read more »
Have it Both Ways: Macros that Produce Publication-Quality Tables and Stand-alone Code
There’s an intrinsic tension between setting up an elegant, modular programming system and writing simple, easy-tounderstand programs. Macro libraries have enormous value as a production tool; they allow common applications to be written, validated, and reused easily. However, they often contain a great deal of obscure code designed to produce ‘pretty’ results. For some audiences… Read more »
Comparison of Techniques for XML and RTF Tables
Statistical Table Specifications and Automatic Code Generation Using XML
We present a general table model for display of statistical results from a typical clinical trial and describe an application to generate table descriptions in XML. This XML file is then used as input to a SAS code generating application which creates a SAS driver program built with validated macros. The table descriptions and associated… Read more »
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