What is a Clinical Data Warehouse?

A clinical data warehouse is a collection of data that is originated from an operational database management system.   The purpose of this is for analysis and reporting of clinical trials data for the FDA, usually in the form of an electronic submission.  The clinical data warehouse is organized by subject such as projects and studies.  It is different from an operational database in that it may contain summarized data for a particular analysis. 

What is the Trialex System?

The Trialex System is a web-based system that automates the creation and maintenance of a clinical data warehouse.  It creates an environment to manage:

• Reports
• Source Data
• Analysis Data
• SAS Programs
• Dependencies
• Status
• Documentation

The Trialex System enables you to capture and manage the metadata pertaining to these objects within the clinical data warehouse.  It sets standards by organizing the objects in an object-oriented model.   It manages the dependencies between the objects and the refreshing of the warehouse by submitting the programs in their proper order.  The attributes of all the objects, from titles to reports, are centrally managed and easily updated through a friendly web interface.  The Trialex System automates the management of status among the objects and facilitates the communication among team members.  It compiles all the information into a concise and accessible documentation. 

The focus of the clinical warehouse is on the end results which are usually reports.  The flow leads up to the reports as follows:

The clinical data warehouse is a collection of many objects similar to the ones shown in the diagram. 

Hardware and Software Requirements

The Trialex System requires SAS 6.12 on the server machine running Windows NT or UNIX.  The client's machine uses a web browser IE, or Netscape 4.0 or greater, to access the Trialex System.  An email client is also required for the client's machine. 

Tour of the Main Pages

The following lists the main pages of the Trialex System.  Each page is followed by a brief description.

Administration Tools - The administrator's main page.  This contains tools to set up users, clinical levels, job schedules.

Study Design - This contains design tools including object dependencies and level designs.

Study Conduct - This page contains all the tools to carry out the tasks of a clinical study.  This includes the management of the objects, reports, programs, data.  This also includes tasks such as refreshing objects, first pages, table of contents, status and documentation.

Customizing the Trialex System

The Trialex System can be customized to fit the work environment.  It is recommended that this activity be reserved for an administrator so that changes occur consistently.  There are some graphical tools which assist in configuring the Trialex System but, in general, this is done in batch mode by a tool named %config.  This section will introduce some of the configuration settings and is not intended to be a complete reference.  For more details, please refer to the configuration reference section.

Before studies are set up in the Trialex System, the organizational hierarchy, in which the studies are defined, needs to be established.  This is found in the levels section in the administration tools area.  

Levels defined in this section will affect how standards are established since the studies will be defined within each level.  More detailed description of the level management tools are available in the reference section.

Many of the pull down menu items within the Trialex System are customizable.  This is usually established during installation although changes can be applied at any time.  One example is the report type.  This categories the different types of reports for easier access.  The report type is shown in the pull down menu of the report object as shown here:

The report type can be used in multiple areas.  Another example where the report type is referenced is in the options for generating the Table of Contents (TOC).  In this example, the report types are choices which can be excluded form the TOC.

The values which define the report type can be configured so that all references to it will contain the same list.  This is defined with a batch macro named %config.  This macro has to be invoked for each report type. In the example above, the SAS program utilizing the %config macro would look like:

%config (param=Report Type [1], value=Listings);
%config (param=Report Type [2], value=Summary Tables);
%config (param=Report Type [3], value=Figures);

For central management of these types of customization settings, it is recommended that all the values defined, such as the report type, be included in one centralized SAS program.  This way, it is easy to find all the settings in one central location.  This is one example of many parameters which can be configured.  For more details on the other options, refer to the administration configuration section.