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Computing Environment

Hardware Resources

The CTSDMC currently utilizes 10 Microsoft Windows 2008 and 2003 Servers and services 40 local clients (on-site personal computers, laptops, printers, etc.), and provides services for additional clients at remote locations.†The servers are used for a variety of functions, including file storage, database storage, data backup, multiple users access, printing, FTP, web application servers, and remote communications with clinical centers. Each server is protected by an uninterruptible power supply (UPS) from American Power Conversion Smart, which provides surge protection and backup power.†

Software Validation

The CTSDMC development environment used for creating the online data entry systems employs Microsoft Visual Studio.Net to create Active Server Pages (ASP/ASP.Net).† ASP is a server-side scripting technology from Microsoft that allows web developers to generate dynamic, data-driven web applications. ASP scripts are able to connect directly to the SQL Server database using ActiveX Data Objects (ADO).

After a program is written, it undergoes multi-phase testing to ensure that it is working properly.† The first phase of testing is when the individual who has written the program debugs and tests the accuracy of the code.† This programmer uses a database, developed specifically for and linked directly to the program, to test code functionality.† Once the programmer has performed these assessments, the programmer places the code into an integration environment where other members of the development team evaluate the logic of the program and its adherence to industry standards.

The next phase of testing is called validation testing. This phase is designed to specifically assess the systemís capability to perform in an environment similar to that which will be used in the production environment.†The programming development staff and the independent testing team evaluate the program using a variety of tests, including: evaluations of system security, faults, error messages, roles, serviceability, and system performance under a heavy volume of data (i.e., simultaneous data entry by multiple users). Sample data sets are generated to specifically test these situations.† These data sets include both valid and invalid values in order to assess whether the program processes these values correctly.†Additionally, input is sought from application users outside the CTSDMC regarding user interface acceptability.† During validation testing, a tracking database is used to document bugs and to identify design issues.†Once all validations have been performed and all functions have been integrated, a final data run is performed.† This final testing validation is stored as part of the software validation documentation.

Following validation testing, the software is ready for production (i.e. software is released for use by clinical centers, study coordinators, and others for whom the software is intended).†