ABSTRACT TECHNICAL DESIGN INTRODUCTION FUNCTIONAL DESIGN

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1 Overview of a Browser-Based Clinical Report Generation Tool Paul Gilbert, DataCeutics, Pottstown PA Greg Weber, DataCeutics Teofil Boata, Purdue Pharma ABSTRACT In an effort to increase reporting quality and lead to decrease time-to-market, drug development organizations are focusing on automating the clinical reporting generation process. SAS-based data and tools have been key to generating most of the analysis and reports that are included in the clinical sections of regulatory submissions. Many companies are developing applications to automate this process. DataCeutics has developed the DataCeutics Report Portal (DRP) to address this need. The DRP is a browser-based thin-client application for producing SAS Reporting. The DRP allows users to login, select a project, and select a study within the project. Study selection activates the study functions. Study functions include: Building, testing and saving a SAS report generation program. Re-executing multiple SAS programs. View the SAS source program; SAS log or SAS output files (ASCII, RTF, HTML, PDF or XML). The DRP was developed using the SAS system, SAS/IntrNet application, HTML code and Java Script. This paper is an overview of the functional design of the DRP application. Its focus is the technical design and the functional design of the system. INTRODUCTION SAS-based data and tools continue to generate the majority of the analysis and reports that are included in the clinical sections of regulatory submissions. To increase reporting quality and decrease time-to-market, drug development organizations are focusing on streamlining the clinical report generation process while improving compliance with regulatory guidelines. DataCeutics Inc. has developed the DataCeutics Report Portal (DRP) to address this need. The DRP is a browser-based thinclient application for automating the production of SAS Clinical Reports. The primary design goals of the DRP include: Enforcing a 21 CFR Part 11 compliant SAS programming environment. Management of a development/production SAS programming environment. Application level security to control access at a project level. Server-based application requiring only a web browser i.e. SAS is not required on the client. Ability to register general, project and study specific SAS report programs. Ability to leverage current reporting software or commercially available reporting software. Support for multiple output formats (e.g. ASCII, HTML, RTF, PDF, XML) through full support of the SAS Output Delivery System (ODS) Centralize management of project/study meta data (e.g. Titles, Footnotes, Report Registration data). The primary users of the DRP are the Statistical Programmers and Statisticians. The primary function of the DRP includes: Selecting projects, studies and data. Sub-setting data files. Creating SAS programs. Executing the SAS programs to generate SAS output. Viewing and downloading the SAS source, log and report output on the user s workstation. This paper is an overview of the technical and functional design of the DRP application. TECHNICAL DESIGN The system was developed using the SAS system, SAS/IntrNet application, HTML code and Java Script. The SAS/IntrNet architecture contains three components: a web browser, a web server (application broker) and the SAS application server. The web browser resides on a user s workstation. The application broker can reside on a Windows or UNIX web server. The application server resides on a central SAS UNIX server. The DRP home page was developed as a static HTML page that resides on the web server. There are additional, home pagerelated, JavaScript, image and HTML files stored on the web server. Subsequent system pages are dynamic HTML pages created by the execution of SAS programs. All registration (metadata) files are SAS datasets. The SAS programs produced by the DRP are stand-alone SAS programs that can be executed via the user interface or, if needed, from the command line. The majority of the system files, metadata, Build Templates and data reside on the central SAS UNIX server. FUNCTIONAL DESIGN The system is a thin-client, server-based, HTML and SAS application. It acts as a user interface to the report generation software stored on the SAS server. The purpose of the system is to produce the reports that are included in regulatory submissions, via thin-client user interface. The interface allows the user to generate SAS programs, select patient subsets, execute SAS programs, generate SAS output files, view SAS source files, view output files, view SAS log files and re-generate output. A DRP Administrator registers the projects, studies and users to the system. The study registration process references existing directories that contain SAS data, SAS programs; SAS log files and SAS Output. SAS programs called Build Templates are developed by SAS programmers and registered to the system by the DRP Administrator. A Build Template is the SAS program that generates a SAS report generation program. The Build Template generates the user selection screen for a report and allows the user to create a SAS report generation program that is saved to the system. Once this SAS program is saved, it is referred to as a saved report program. The system requires users to login using a UNIX account, select a project, and select a study within the project. The study selection box allows the user to work in a production or development mode. In development mode, after selecting a study, the user selects a data domain. From there, the users can build a subset, run Build Templates and save and run the report generation program.

2 Once reports have been created, the user can view the SAS source files, output files and SAS log files. Once the reports have been moved to production, the subset and Build Template functions are not active. The graphics below walk through the application interface. STUDY FUNCTIONS The primary study functions are Build Report, Run Report and View Report. DRP LOGIN PAGE The DRP uses the SAS/IntrNet host-based security model for first level security and application-based security to manage menu access. The system requires users to login using a UNIX account. The Build Report function allows the selection of a Domain, the ability to create a Subset or Build a Report program. The Build Report function is active in Development only. DRP HOME PAGE The home page is used to manage study selection and study functions. The user selects a project and then selects a study within the project. The study selection also allows the user to select a development or production version of the study. The projects and studies are registered to the application as part of the study set-up process. CREATE A SUBSET FUNCTION The Subset function uses the variables in the current dataset to build subsets. The first page of the Subset function allows for the selection of a variable.

3 The second page of the Subset function allows for the selection of an operator and a value. REPORT SELECTION FUNCTION A Build Template is a SAS program that is used to generate a SAS report generation program. A Build Template generates the user selection screen for a report and allows the user to create a SAS report generation program that can be saved to the system. The Build Templates, with default settings, are registered to the application as General or Study-Specific Build Templates. The Build Templates are SAS report programs that can call other SAS programs or standard reporting macros. Commercially available software (e.g. CR Toolkit.) can be used as the back-end report generator. The first page of the Report function displays the Build Templates that are active for the domain. The third page of the Subset function allows for changing the subset description and defining additional subset criteria. A Build Template contains Report-specific and Standard Report Options. Standard Report Options are displayed on all Build Template selection pages. Standard Report Options can be customized for each Client. Build Templates can be executed in Test or Save mode. The page below displays report-specific options for a demographics Build Template. After the Subset creation is complete, the data file is sub-setted using the active subset. The Active Domain and Active Subset status lines are updated. The subset will remain active until another domain is selected or the reset button is selected. When a report generation program is saved, the subset logic is also saved and applied on subsequent executions of the report program.

4 The page below is the bottom of the previous page. It displays Standard Report Options. In this example, the Standard Report options include selections of study phase, study populations, titles, footnotes, output type, report layout, test/create and program name. The file is delivered to a desktop for Viewing. The example below is an ASCII file that was opened using SAS Viewer. Here, the file delivered to a desktop is in RTF format. It was opened using MS Word. The user can select either test mode or save mode. When running in test mode the results (report output and SAS log) will be returned to the browser window. The stand-alone report generation program is not saved. Once satisfied with the report output, the user selects save mode to save the results to a permanent location on the SAS server. The user has the option of overwriting existing output or giving the results a new name. After the program completes execution, file links to the report results, the SAS log and SAS program are returned in a browser window. RUN REPORTS FUNCTION The Run Reports Function is the second study function. It allows for execution of multiple SAS programs in Batch Mode. The Run Saved Programs page, below, is the primary page. There are several options (e.g. when to run) for executing programs. Selection of a file link will deliver the file to the Desktop Application for Viewing. A download page is displayed after the selection of the SAS source file, log or output file. This will download the file, through the browser, to the user s desktop.

5 The program execution information is displayed, after execution is submitted. VIEW REPORT FUNCTION The View Reports Function is the third study function. It displays the files on the SAS Server and allows download and viewing access from the browser. Selection of a file link will deliver the file to the Desktop Application for Viewing. A download page is displayed after the selection file. This will download the file, through the browser, to the user s desktop. The example below is a SAS source program file that was opened using SAS Viewer. CONCLUSIONS The primary focus of the DRP is to increase reporting quality and to decrease time-to-market while complying with regulatory guidelines. This was accomplished by addressing three primary design goals: Automating Clinical Report Generation. Providing a server-based application that requires only a web browser on the client. Enforcing a 21 CFR Part 11 compliant SAS programming environment. The DRP automates clinical report generation by allowing the user to create programs and output without programming intervention. Once the standard reports are implemented as Build Templates with user selections, the users can create the studyspecific programs and output with various populations and subsets. Once created, the programs can be moved to production, and then re-executed as the study data is loaded and finalized. The DRP is a server-based application that requires only a web browser on the client. SAS is installed on the server and all processing occurs on the SAS server. This allows for minimal management of the user s desktop and more efficient use of software and hardware resources. The thin-client architecture provides excellent performance in low-bandwidth situations, for example wide area network, dial-in modem. This allows multiple sites to utilize a large central server while maintaining acceptable performance. The DRP helps to enforce a 21 CFR Part 11 compliant SAS programming environment by allowing for creation and management of programs and output in a validated environment. The DRP application software itself is validated and the Build Templates are validated prior to being placed into the production environment. The programs and reports are created and tested in the study-specific development area. The programs are then moved to the study-specific production area where they can be reexecuted and viewed, but not modified. NEXT STEPS One of the next steps is to implement an automated Move-to- Production function. This function will move programs and related files from the study-specific development area to the study-specific production area. Additionally, there will be an audit trail of all programs as they are moved to production. CONTACT INFORMATION Your comments and questions are valued and encouraged. Contact the author at: Paul Gilbert DataCeutics Inc x207 gilbertp@dataceutics.com DataCeutics, Inc. is a SAS Alliance Partner and a CDISC member. CR Toolkit and DataCeutics Report Portal (DRP) are registered trademarks or trademarks of DataCeutics Inc.

6 SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. Indicates USA registration.