“ DataFax levels the playing field for our small company in competing with the 'big companies'. Long gone are the days of the slow and labor-intensive process of physically retrieving hard copy case report forms from investigative sites, and thumbing through them for data entry and clean-up. ”

Hardware and Software Requirements

DataFax is a client-server application and accordingly can be configured in a variety of computing environments from a minimum of one machine, acting as both client and server, to a network with multiple clients and multiple servers.

Required Infrastructure

Most computing environments already include the following infrastructure. However, if these components are not currently available, they will be required before a successful DataFax installation.

  • TCP/IP networking
  • PostScript compatible printer for CRF printing
  • Backup system for safe archival and retrieval of computer data
  • Desktop publishing package for CRF creation

DataFax Server Software

DataFax server software runs on any hardware platform that supports SPARC or Intel Solaris 10 (compatible systems are available from Sun and Dell), SUSE LINUX, and MAC OS 10.5 (Leopard).

Fax Services

Faxes can be sent and received using the MyFax internet fax service available from Protus or by setting up your own fax modem pool on the DataFax server. To set up your own modem pool you will need a serial port for each incoming/outgoing fax line. Since most server systems come with only one or two serial ports, an additional serial port multiplexer may be needed to support additional fax lines.

DataFax Client Software

DataFax includes 3 internet based client tools:

  • DFsystem - for study, permissions and user management
  • DFsetup - for study configuration
  • iDataFax - for data and query management, reports, SAS exports, etc.

Each of these tools can be installed on a PC running Windows 2000, XP or Vista, or on an Apple Macintosh Computer running OS 10.4 or higher.

Frequently Asked Questions

What type of browser do users need?

You don't need a browser at all. All 3 of the DataFax client tools are compiled C++ programs which run natively on your PC or MAC. They communicate with a DataFax server at the study coordinating center using a secure connection over the internet but they do not use the world-wide-web.

What type of desktop/laptop do users need?

All 3 client tools are available under both MS Windows and Apple OS X, and require about 10 MB to install, including the built-in user guides. iDataFax does not store any patient data or CRF images on your PC and thus does not require additional disc space regardless of how many studies you participate in. During data entry iDataFax retrieves patient data as needed from the central server and performs all edit checks on your PC or MAC. This has the advantage that you are not waiting for the central server to run checks and report back to you, but it also means that your desktop machine needs to have an adequate amount of power and memory. Any modern PC or MAC with at least a 1 GHz processor and 500MB of RAM should be adequate. iDataFax is not likely to run well or at all on stripped down devices designed only for surfing the web.

What size and type of computer monitor works best with DataFax?

When comparing images of faxed CRF pages or scanned source documents with their corresponding data screens a display resolution of at least 1280x1024 is recommended. Smaller resolutions require more freauent scrolling to review all parts of each page. At 1600x1200 resolution it is possible to view two full pages side-by-side without scrolling which is perfect for comparing image and data screens.

Can I use my current desktop publishing package for creating DataFax compatible CRFs?

DataFax uses PostScript and/or PDF as an interchange format for importing blank CRFs into the DataFax DFsetup tool. Hence, any desktop publishing package that is capable of saving your CRFs to a file in PostScript or PDF format will work.

CRFs contain graphical elements such as boxes for digits and check marks, horizontal rules for text transcription and visual analog scales, and rectangles for grouping. Use a desktop publishing package that has as much flexibility in dealing with these graphical elements as it does with text.

If you have to purchase a desktop publishing package, we recommend FrameMaker from Adobe Systems because of its tremendous flexibility and ease of use. The DataFax software also includes a FrameMaker plug-in that creates standard DataFax barcodes for your CRFs.

Are all PC systems capable of running x86 Solaris?

In general, yes. x86 Solaris is a product of Sun Microsystems and Sun makes available a complete list of certified, compatible hardware. Read Sun Microsystems' Solaris Hardware Compatibility List.

There are a number of companies that provide "out-of-the-box ready" PC hardware with x86 Solaris pre-installed and compatibility certification.

What type of modems are compatible with DataFax?

We recommend the Multitech line of modems, in particular the MT5634ZBA-V92, MultiModemZBA V.92, MT5656ZDX, MT5600ZDX, MT3334ZDX, MT2834ZDXb, MT2834BA, and MT1932ZDX (some of these modems are out of production but are still readily available), although other modem brands and manufacturers are supported. In general, the modems should be Class 2 compatible, capable of 14,400 baud transmission speeds, and understand the Hayes or Rockwell command set.

How much disk space will I require on the central study server?

The DataFax server software itself is approximately 300 MB, with all of the documentation installed. In a networked environment, the DataFax software is installed on one of the server machines, and then accessed by other UNIX machines via NFS.

Most of the disk space that is required by DataFax is for on-line storage of CRF pages received by fax.

As a rough estimate, plan on 1GB of disk storage per 40,000 CRF pages. You can calculate the total number of CRF pages for a study by multiplying the planned number of patients by the number of pages per patient case record book by the refax rate. Experience has shown that corrections on CRFs leads to about 25% of forms being refaxed, leading to a refax rate of 1.25. Disk storage for CRF pages can be spread across the UNIX machines in your DataFax environment.

Additionally, disk storage is required for the study data and other study definition files. Again experience has shown that this is about 10% of the storage required for the CRF pages. Optimal performance is achieved by storing study data on a disk that is local to the CPU that is running the study server.