This year we have a large number of submitted papers, which were written by SAS experts from all over the world. Among these great papers, here are a few selected papers that were chosen by conference committees.
- FDA Submission Overview - eCTD preparation - Cindy Song, Sanofi
- Strategy to Start to Implement CDISC Standards - Victor Wu, Data Science Express Consulting Co.,Ltd
- Animate Your Safety Data - Kriss Harris, SAS Specialists Ltd.
- Annotate Your SGPLOT and GTL Graphs - Sanjay Matange, SAS
- SAS Studio: We Program! - Matt Becker, SAS
- You Want ME to Use SAS Enterprise Guide? - Vince DelGobbo, SAS
- The Impact of Change from WLATIN1 to UTF-8 Encoding in SAS Environment - Hui Song and Anja Koster, PRA Health Sciences
- What’s the BIG Deal with Missing Data? - Mina Chen, Roche and Peter Eberhardt, Fernwood Consulting Group
This paper gives an overview of an FDA e-submission package – what is included in the submission and how to prepare for a submission package. The content and structure of a typical e-submission package will be presented.
CDISC is a data standard mainly for clinical trials, covering protocol presentation, CRF design, data tabulation, analysis data, data exchanging and archiving. Both the US FDA and Japanese PMDA have announced the requirement to submit data following CDISC standards. In the newly released CFDA guidance, CDISC standards are also recommended. When and how should you start to implement CDISC standards? In this presentation, we are going to discuss the strategies on timing, rationale and from A to Z the implementation of CDISC standards in a company.
When reporting your safety data, do you ever feel sorry for the person who has to read all of the laboratory listings and/or summaries? Or do you ever wonder that there might be a better way to visualize the safety data? Let’s help make the reviewer’s life easier and also understand the safety data better with the use of animation.
This paper shows how you can use animation in SAS 9.4 to report your safety data, such as visualizing a patient’s laboratory, vital sign and electrocardiogram results, and seeing how those safety results change over time. In addition you will learn how to animate adverse events over time, and how to show the relationships between adverse events and laboratory results using animation. Animating your data will bring your data to life and help to better more lives!
The SG procedures provide you multiple plot statements to create many different kind of graphs. These plot statements can be used together in creative ways to build your graph. However, even with this ability to customize, there are times when you need more than what you can get using just the plot statements. You need a way to add custom information anywhere on the graph.
With SAS 9.3, the SG procedures support the ability to annotate the graph using data set based information. With SAS 9.4, GTL also supports annotation. This annotation functionality is designed in a way similar to the annotate facility available with the SAS/GRAPH procedures. There are a few differences and enhancements. If you already know annotation from SAS/GRAPH, or if you are new to it, this paper will show you how to add custom annotations to your graphs.
Have you investigated SAS Studio!? From the 1980’s into the 2010’s I used SAS Display Manager (PC SAS front end) for all of my clinical table, listing, figure and database program development. I became accustomed to the program editor, log window, output window…being able to view my working and saved data sets via this programming IDE. I resisted new coding editors through the years UNTIL SAS Studio came to fruition!
SAS Studio is a web-based application that accesses your SAS environment – cloud, local server(s) or PC. With the environment, you can access your data libraries, files and existing programs…and write new programs! Additionally, SAS Studio contains pre-defined tasks that generate code for you. Have a specific set of clinical programming code you always use? Snippets! Want to define a personal or global task for AE table summarization? Define it within SAS Studio!
Starting with SAS9, one copy of SAS Enterprise Guide is included with each PC SAS license. At some sites, desktop PC SAS licenses are being replaced with a single server-based SAS license and desktop versions of Enterprise Guide. This presentation will introduce you to the Enterprise Guide product, and provide you with some good reasons why you should consider using it.
As clinical trials become globalized, there has been a steadily stronger growing need to support multiple languages in the collected clinical data. The default encoding for a dataset in SAS is “WLATIN1”. WLATIN1 is used in the “Western world” and can only handle ASCII/ANSI characters correctly. UTF-8 encoding can fulfill such a need. UTF-8 is a universal encoding that can handle characters from all possible languages, including English. It is backward compatible with ASCII characters. However, UTF-8 is a multi-byte character set while WLATIN1 is a single-byte character set. This major difference of data representation imposes several challenges for SAS programmers when (1) importing and exporting files to and from WLATIN1 encoding, (2) reading in WLATIN1-encoded data sets in UTF-8 SAS environment, and (3) creating WLATIN1-encoded data sets to meet clients’ needs. In this paper, we will present concrete examples to help the readers understand the difference between UTF-8 and WLATIN1 encoding, and provide practical solutions to address the challenges above.
In clinical trials, a major problem in the data analysis is missing values caused by unrecorded results of measurement at some planned visits or patients dropping out of the study before completion. Missing values can have a surprising impact on the way that data is dealt with, which may result in biased treatment comparisons and also impact the overall statistical results of the study. Generally, missing values can be represented by SAS in a number of ways, there are various functions, options and techniques associated with missing values, and procedures will have specific ways of handling them. However, not all SAS programmers are aware of the System options, DATA step functions, and DATA step routines that specifically deal with missing values. This paper will include the basics of how to detect missing values, and how to effectively make use of various functions and tools within SAS to utilize missing values.