Users are provided with a simple, user friendly application for accessing collected data matching their exact specifications without assistance. Freed from their reliance on programming staff, our users are better able to access the data they need.

While outlying data points can provide valuable information, researchers are often skeptical of their legitimacy. We've created an application to allow researchers to verify data against original faxed images, increasing both the validity of aggregated results, and confidence in the provided data.

We present the methods and applications we've created to streamline the dissemination of information gathered in DataFax to end-users.

The new coding tool is using the lookup table function based on the MedDRA tables and works closely with the standard MedDRA browser. The specific lookup tables are generated with a SAS program or a special MsAccess database application. Although the present tool is developed to code Adverse Events in a simple manner it implements the MedDRA hierarchy in a reliable fashion and produces consistent results. In short, the AE verbatim is copied from the Adverse Event page and can be adjusted to achieve the most appropriate Lowest Level Term. Once this term is selected the Preferred Term and Code, System Organ Class Term and Code are returned automatically.

This lightweight coding tool enables DataFax users to code Adverse Events within DataFax without the need for external applications (with the exception of the MedDRA browser). We find it feasible to use in the setting of medical device studies that typically have a low number of subjects and Adverse Events. Furthermore, this tool may be worthwhile for smaller companies for which costs for auto coding programs can be significant. At the DFUG 2009 we would like to demonstrate how this coding tool is built and can be used.

At DFUG 2008, we demonstrated the DfRTools prototype and presented examples of standard DataFax reports and their DfRTools equivalents, and showed some additional DfRTools reports not available from DataFax. This has generated interest in the DataFax community during the last year, prompting us to demonstrate and provide the DfRTools package to several groups. We have received very positive feedback from these interactions, but the complexities of ANT, Open Office, and the R interface has raised some concern about the ease of implementation and use. As a result, we have concentrated on increasing usability by enhancing end-user functionality and improving some technical features of the package. This effort revealed that a graphical user interface (GUI) to DfRTools could manage the details of ANT, Open Office, the R interface and DataFax reporting, eliminating the need for users to understand the package's internal structure and interaction. In this presentation, we will demonstrate a working version of the DfRTools GUI and new additions to the package. We hope that our presentation will generate more user feedback and interest to extend our collaborations with DFUG users.

Our standard operating procedures require us to perform quality control review of QC reports prior to distribution. Transitioning to DataFax has provided us the ability to create a tool that allows us to graphically review the QCs and the data image for validation errors. To accomplish this DFtips, data images and the QC database were combined into a report displaying the QC along with a picture of the field in question. Transitioning to DataFax also allowed us to automate the creation of a variable reference guide for use by our statistical programmers. Utilizing the background images, and the DFtips and DFschema files, an annotated set of case report forms (CRFs) were created to serve this purpose.

In this presentation we will demonstrate how these tools were developed and how they are used today.

The requirements for DFpdf are an input file and study number. Here I use drf file as input file. There are two ways to produce drf files. First, by using Dfexport.rpc in shell script program to create a file that contains the key information, which are id, plate, sequence number and raster number. Then a SAS program will read the file to produce a drf file for each id. The other way is to use Dfsas program to export data from DataFax to SAS, after all the data files are created, apply SAS program to read the data files then produce all the drf files. A shell script program will map id number to the corresponding drf file. With this input file and study number, DFpdf will give us the PDF documents of CRF images.

In order to arrange the bookmarks of the pdf documents in the way we prefer, we also need to do some modifications to Dfqcsort, Dfvisit_map and Dfpage_map.

The way we do to produce PDF file is 6 times faster than that only using shell script programming, and is easy to use by just typing the program name followed by study number and directory.

Questions: How can we use DFpdf in the web-based DataFax that has no images? If this question can be solved, then we can print data on the CRFs. DataFax programs to be used: DFpdf, Dflistplates.rpc, Dfsas, Dfexport.rpc.

Furthermore, there can also be 'technical' reasons why the DFpdf utility does not meet all requirements for a CRF archive. Like the inclusion of other sources of information, such as lab reports, Audit Trail information, or Query information. We will discuss some of the internal challenges to collect and combine this information. As well as some external tools which can be used to handle and bookmark the different sources of information. And present some examples of possible output.

But at the same time, having more than one physical server comes with a real price. Costs for the initial purchase, ongoing support, physical space, and power requirements are multiplied. And trying to keep two or more systems reasonably patched and synchronized is truly an administration challenge.

"Zones," a feature of the Solaris 10 operating system, offers a solution to this: the ability to run multiple applications, including DataFax, all on one physical machine. Rather than buying multiple systems, you can slice up a single machine into as many "virtual" machines as you need. These virtual machines can share or not share resources as you wish. They can be easily built, rebooted, and even thrown away and built again with ease. And the best part is that the functionality is free with Solaris 10.

The presentation will cover, in non-technical language:

• What Solaris zones are
• Why you might want to use them
• Cost implications
• How they are constructed and used
• Limitations and DataFax problems to overcome
• Online resources

Virtualization is increasingly becoming a popular way to reduce the cost and complexity of managing numerous small servers that host just one application. These same concepts can easily be applied for running multiple versions of DataFax.

The Process will include failing over HylaFax Enterprise, DataFax 3.7, and the steps required to validate and execute a DRP (Disaster Recovery Plan).