Generate Web-based Clinical Reporting System

(e-CRS)

Jianquan WangDepartment of Computer Science

Ball State University

October 16, 2000

What’s Web-based What’s Web-based Clinical Reporting Clinical Reporting System (e-CRS)System (e-CRS)

A Clinical trial is an experimental study of A Clinical trial is an experimental study of evaluation of safety and efficacy of medication(s) evaluation of safety and efficacy of medication(s) or medical device(s) using human beings as study or medical device(s) using human beings as study subjectssubjects

Clinical Study Reports include output results from Clinical Study Reports include output results from data analyses such as reports, tables, and graphs, data analyses such as reports, tables, and graphs, and other documents such as Word, Excel, and PDF and other documents such as Word, Excel, and PDF files.files.

Web-based Clinical Reporting System is an Web-based Clinical Reporting System is an integrating reporting system via web pages and integrating reporting system via web pages and hot-links to incorporate various clinical study hot-links to incorporate various clinical study reports and documentsreports and documents

Research ObjectiveResearch Objective

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

Literature ReviewLiterature Review

SAS stands for Statistical Analysis Software, a SAS stands for Statistical Analysis Software, a software package widely used in statistical software package widely used in statistical analyses and reporting of data analyses and reporting of data

SAS Institute (http://www.sas.com) provides SAS Institute (http://www.sas.com) provides some examples about how to convert SAS some examples about how to convert SAS output to static HTML fileoutput to static HTML file

Ray Pass (2000) describes his basic method to Ray Pass (2000) describes his basic method to connect a collection of static and related SAS-connect a collection of static and related SAS-based output HTML filesbased output HTML files

Current Challenges in Current Challenges in Clinical Study Clinical Study

ReportingReporting

The evaluation of drug safety and efficacy is The evaluation of drug safety and efficacy is usually associated with vast volume of data, usually associated with vast volume of data, substantial data analyses, and tons of study substantial data analyses, and tons of study reports.reports.

Most of results of data analyses in clinical Most of results of data analyses in clinical studies are based on SAS output reports, studies are based on SAS output reports, tables and graphs, which are paper-based text tables and graphs, which are paper-based text filesfiles

Review and approval of clinical reports are Review and approval of clinical reports are tedious, time-consuming, and costlytedious, time-consuming, and costly

Importance of the Importance of the ResearchResearch

Web-based clinical reporting system with hot-Web-based clinical reporting system with hot-link and data-driven features integrates various link and data-driven features integrates various clinical reports (SAS HTML output, tables, clinical reports (SAS HTML output, tables, graphs) and documents (Word, Excel, PDF)graphs) and documents (Word, Excel, PDF)

Provides reviewers convenience, ease, and Provides reviewers convenience, ease, and efficiency to access and review the reportsefficiency to access and review the reports

Shorten review time significantly and save cost Shorten review time significantly and save cost tremendously from paper-based outputtremendously from paper-based output

Organize and present clinical study reports in a Organize and present clinical study reports in a systematic and logic waysystematic and logic way

Design of Web-Design of Web-based Clinical based Clinical

Reporting Reporting SystemSystem

Types of Clinical Types of Clinical ReportsReports

General Information: General Information: * Subject Demographic Characteristics * Subject Demographic Characteristics * Subject Disposition * Subject Disposition

Safety Reports:Safety Reports: * Treatment-Emergent Symptoms and Signs * Treatment-Emergent Symptoms and Signs (TESS)(TESS) * Concomitant Medications * Concomitant Medications * Laboratory observation * Laboratory observation

Efficacy Reports:Efficacy Reports: * Clinically Global Impression Severity (CGI-S) * Clinically Global Impression Severity (CGI-S)

Layout of Web-based Layout of Web-based Clinical Reporting Clinical Reporting

SystemSystemThe e-CRS The e-CRS system system includes includes two two panels: panels:

(1) Left (1) Left panel for panel for hot-links of hot-links of individual individual pages, pages, click on click on each hot-each hot-link will link will launch launch each web each web page page

(2) Right Panel for (2) Right Panel for presentation of individual page presentation of individual page

How to Create How to Create Web PagesWeb Pages

Types of Source FilesTypes of Source FilesThere are two types of Clinical Reports depending on There are two types of Clinical Reports depending on

the sources of reports or documents:the sources of reports or documents:

(1) SAS-based output HTML files (1) SAS-based output HTML files Output reports and tables from SAS analyses. Output reports and tables from SAS analyses. Static web pages can be generated using SAS Static web pages can be generated using SAS HTML formatter tools (%DS2HTM, %TAB2HTM) HTML formatter tools (%DS2HTM, %TAB2HTM)

(2) Derived Clinical Documents(2) Derived Clinical Documents Study documents (Word, Excel, PowerPoint, Study documents (Word, Excel, PowerPoint, Image file) are generated using clinical data or Image file) are generated using clinical data or results from SAS output, then used as sources results from SAS output, then used as sources document to convert into HTML files. document to convert into HTML files.

Convert SAS Convert SAS Data and Output Data and Output Table into HTML Table into HTML

FilesFiles

Convert SAS data into Convert SAS data into HTML file using HTML file using

%DS2HTM%DS2HTMSAS SAS Listing Listing OutputOutput

SAS SAS Output Output HTML file HTML file using using %DS2HTM%DS2HTM

Convert SAS table into Convert SAS table into HTML tabular file using HTML tabular file using

%TAB2HTM%TAB2HTMSAS SAS Output Output TableTable

SAS HTML SAS HTML Tabular Tabular file using file using %TAB2HT%TAB2HTMM

Create HTML files Create HTML files from other from other documentsdocuments

Word File into HTML Word File into HTML FileFile

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

Excel-based Chart into Excel-based Chart into HTML image fileHTML image file

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

Access Other Access Other Documents via Documents via

Hot-LinksHot-Links

Open Excel File via Hot-Open Excel File via Hot-LinkLink

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

Navigate through the e-Navigate through the e-CRS System (1)CRS System (1)

Open e-CRS home pageOpen e-CRS home page Click e-CRS OverviewClick e-CRS OverviewNext Next PagePage

Navigate through the e-Navigate through the e-CRS System (2)CRS System (2)

Click on Demo pageClick on Demo page Click on Gender Hot-linkClick on Gender Hot-linkNext Next PagePage

Navigate through the e-Navigate through the e-CRS System (3)CRS System (3)

Click on Back button on Click on Back button on top left corner to return to top left corner to return to Demo page. Then click on Demo page. Then click on Origin Hot linkOrigin Hot link

Click on e-CRS Click on e-CRS Disposition hot linkDisposition hot link Next Next

PagePage

DeliverablesDeliverables

Web-based Clinical Reporting Web-based Clinical Reporting System (e-CRS) with various web System (e-CRS) with various web pages, image files, documents in pages, image files, documents in Word, Excel, PowerPoint, PDF Word, Excel, PowerPoint, PDF format).format).

Technical Report for the Web-Technical Report for the Web-based Clinical Reporting Systembased Clinical Reporting System