PhOSCo

PhOSCo is a complete electronic data capture system for multi-site clinical trials that has been in use for seven years. It is written in object-oriented Java and works with ANSI-standard SQL engines as long as a JDBC method is written for the engine. It has a low-cost commercial license and an essentially free academic license. Its open-source community portal is at http://www.phosco.org. Downloadable manuals may be obtained from http://www.phosco.com.

A GUI is used to design the database; no scripting language is supported. Extensive capabilities are in place for re-use of fields and case report forms. PhOSCo handles a lot of icing on the cake such as allowing a trial monitor (usually a research nurse) to mark the status of every data point, and to write notes about queries on a variable when its value is suspicious, where the site can add to the note until the query is resolved. It is easy to monitor the audit trail on a per-variable basis. There's also a lot of validation stuff in the FDA sense - validating the data collection process. There is an autocoder that allows users to add codes (e.g., medication names) to an ever-growing central code database. Extensive metadata (including variable labels and units of measurement) are maintained in SQL tables.

Some of the questions we need to answer about the system are the following.

1. Is it HIPAA-compliant? I remember reading that the authors of the software cannot claim to be HIPAA-compliant as the standard also includes requirements of the software installation and setup.
2. Can it work with MySQL or PostgreSQL?
3. It offers online TCP/IP client connections, offline data collection, and web data entry. With the supposedly faster response time for the TCP/IP dedicated client-server is there any reason to use the web server approach other than to relieve users from having to install the java code?
4. Can the system be used for our administrative databases? Or does it key to subject ID in every table?
5. Is it a potential solution for internal projects where we want a quick start? My hunch is that it is, although for some of those projects the overhead of all the auditing capabilities may not be needed (if there is an overhead).
6. When a case report form has a sub-table inside it, what is the export format for analysis?

Working Demo

The best way to get started with PhOSCo is to import a sample trial:

• In TrailBuilder, click File -> Import -> Import Trial and import sampleTrial.xml located in the export directory.
• Now click Trial -> Trial Sites to bring up the Trial Site window.
• Click on the Trial HQ site. That should populate the User in Site box below.
• Click on the Mike Calder user and then click the Update User button to open the Edit New User Details window
• On that window change the User Name to your name and change the User Password to whatever you prefer.
• Click on Ok and then the Done button on the Trial Site window
• Now click File -> Quit. A window will open up asking you to save the current Trail. Click Yes.

• Edit the file usrparms.dat, and change the variables trailno, sitename, actsite, and ServerPort to the following values:

        trialno 555
        sitename Trial HQ
        actsite Trial HQ
        ServerPort 9157

• Now open TrailRecorder. You will be presented with a window to select your name and enter your password.
• A new window will open allowing you to add a new subject. Click Add New
• A new window will open allowing you to enter subject initials. Enter them.
• A new window will open asking for subject id. Just enter 1 here.
• You will then be asked to confirm the initials and the id. Say yes.
• Then you will be back to the All Subjects window
• Click on the new subject you just created and then click Select
• Now explore...

-- FrankHarrell - 19 Jun 2004