1. Generate Web-based Clinical Reporting System (e-CRS) Jianquan Wang Department of Computer Science Ball State University October 16, 2000

2. What’s Web-based Clinical Reporting System (e-CRS) n A Clinical trial is an experimental study of evaluation of safety and efficacy of medication(s) or medical device(s) using human beings as study subjects n Clinical Study Reports include output results from data analyses such as reports, tables, and graphs, and other documents such as Word, Excel, and PDF files. n Web-based Clinical Reporting System is an integrating reporting system via web pages and hot- links to incorporate various clinical study reports and documents

3. Research Objective n To generate web-based Clinical Reporting System (e- CRS) through integrating analysis output (reports, tables, and graphs) and other clinical study documents (Word, Excel, PDF, etc.)

4. Literature Review n SAS stands for Statistical Analysis Software, a software package widely used in statistical analyses and reporting of data n SAS Institute (http://www.sas.com) provides some examples about how to convert SAS output to static HTML file n Ray Pass (2000) describes his basic method to connect a collection of static and related SAS-based output HTML files

5. Current Challenges in Clinical Study Reporting n The evaluation of drug safety and efficacy is usually associated with vast volume of data, substantial data analyses, and tons of study reports. n Most of results of data analyses in clinical studies are based on SAS output reports, tables and graphs, which are paper-based text files n Review and approval of clinical reports are tedious, time-consuming, and costly

6. Importance of the Research n Web-based clinical reporting system with hot-link and data-driven features integrates various clinical reports (SAS HTML output, tables, graphs) and documents (Word, Excel, PDF) n Provides reviewers convenience, ease, and efficiency to access and review the reports n Shorten review time significantly and save cost tremendously from paper-based output n Organize and present clinical study reports in a systematic and logic way

7. Design of Web- based Clinical Reporting System

8. Types of Clinical Reports n General Information: * Subject Demographic Characteristics * Subject Disposition n Safety Reports: * Treatment-Emergent Symptoms and Signs (TESS) * Concomitant Medications * Laboratory observation n Efficacy Reports: * Clinically Global Impression Severity (CGI-S) n Efficacy Reports: * Clinically Global Impression Severity (CGI-S)

9. Layout of Web-based Clinical Reporting System The e-CRS system includes two panels: (1) Left panel for hot-links of individual pages, click on each hot- link will launch each web page (2) Right Panel for presentation of individual page

10. How to Create Web Pages

11. Types of Source Files There are two types of Clinical Reports depending on the sources of reports or documents: (1) SAS-based output HTML files Output reports and tables from SAS analyses. Static web pages can be generated using SAS HTML formatter tools (%DS2HTM, %TAB2HTM) (2) Derived Clinical Documents Study documents (Word, Excel, PowerPoint, Image file) are generated using clinical data or results from SAS output, then used as sources document to convert into HTML files. (2) Derived Clinical Documents Study documents (Word, Excel, PowerPoint, Image file) are generated using clinical data or results from SAS output, then used as sources document to convert into HTML files.

12. Convert SAS Data and Output Table into HTML Files

13. Convert SAS data into HTML file using %DS2HTM SAS Listing Output SAS Output HTML file using %DS2HTM

14. Convert SAS table into HTML tabular file using %TAB2HTM SAS Output Table SAS HTML Tabular file using %TAB2HTM

15. Create HTML files from other documents

16. Word File into HTML File Patient demographics table Word file was created based on information from results of SAS analyses on patient demographics. Then convert Word file into HTML file.

17. Excel-based Chart into HTML image file An chart of distribution of patient by origin was created using MS Excel software. Then it was converted as.jpg image file. Finally it was incorporated into HTML file. Example was shown on the right.

18. Access Other Documents via Hot- Links

19. Open Excel File via Hot-Link Click on hot- link ‘Gender’ on the Patient Demographic Web page. An Excel_based spread sheet with data and graph will be launched (see graph at bottom right).

20. Navigate through the e- CRS System (1) Open e-CRS home page Click e-CRS Overview Next Page

21. Navigate through the e- CRS System (2) Click on Demo page Click on Gender Hot-link Next Page

22. Navigate through the e- CRS System (3) Click on Back button on top left corner to return to Demo page. Then click on Origin Hot link Click on e-CRS Disposition hot link Next Page

23. Deliverables n Web-based Clinical Reporting System (e-CRS) with various web pages, image files, documents in Word, Excel, PowerPoint, PDF format). n Technical Report for the Web-based Clinical Reporting System