Transcript Generating Web-based Clinical Reporting System (e-CRS)

Generate Web-based Clinical
Reporting System (e-CRS)
Jianquan Wang
Department of Computer Science
Ball State University
October 16, 2000
What’s Web-based Clinical
Reporting System (e-CRS)
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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
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.
Web-based Clinical Reporting System is an
integrating reporting system via web pages and hotlinks to incorporate various clinical study reports and
documents
Research Objective
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To generate web-based Clinical Reporting System (eCRS) through integrating analysis output (reports,
tables, and graphs) and other clinical study
documents (Word, Excel, PDF, etc.)
Literature Review
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SAS stands for Statistical Analysis Software, a
software package widely used in statistical analyses
and reporting of data
SAS Institute (http://www.sas.com) provides some
examples about how to convert SAS output to static
HTML file
Ray Pass (2000) describes his basic method to
connect a collection of static and related SAS-based
output HTML files
Current Challenges in
Clinical Study Reporting
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The evaluation of drug safety and efficacy is usually
associated with vast volume of data, substantial data
analyses, and tons of study reports.
Most of results of data analyses in clinical studies are
based on SAS output reports, tables and graphs,
which are paper-based text files
Review and approval of clinical reports are tedious,
time-consuming, and costly
Importance of the Research
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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)
Provides reviewers convenience, ease, and efficiency
to access and review the reports
Shorten review time significantly and save cost
tremendously from paper-based output
Organize and present clinical study reports in a
systematic and logic way
Design of Webbased Clinical
Reporting System
Types of Clinical Reports
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General Information:
* Subject Demographic Characteristics
* Subject Disposition
Safety Reports:
* Treatment-Emergent Symptoms and Signs (TESS)
* Concomitant Medications
* Laboratory observation
Efficacy Reports:
* Clinically Global Impression Severity (CGI-S)
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 hotlink will
launch each
web page
(2) Right Panel for presentation of
individual page
How to Create Web
Pages
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.
Convert SAS Data
and Output Table
into HTML Files
Convert SAS data into
HTML file using %DS2HTM
SAS Listing
Output
SAS Output
HTML file
using
%DS2HTM
Convert SAS table into
HTML tabular file using
%TAB2HTM
SAS
Output
Table
SAS HTML
Tabular file
using
%TAB2HTM
Create HTML files
from other
documents
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.
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.
Access Other
Documents via HotLinks
Open Excel File via Hot-Link
Click on hotlink ‘Gender’
on the Patient
Demographic
Web page. An
Excel_based
spread sheet
with data and
graph will be
launched (see
graph at
bottom right).
Navigate through the eCRS System (1)
Open e-CRS home page
Click e-CRS Overview
Next Page
Navigate through the eCRS System (2)
Click on Demo page
Click on Gender Hot-link
Next Page
Navigate through the eCRS 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
Deliverables
Web-based Clinical Reporting System
(e-CRS) with various web pages, image
files, documents in Word, Excel,
PowerPoint, PDF format).
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Technical Report for the Web-based
Clinical Reporting System
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