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OpenClinica Extensions:
From Nano to MacroThomas M. Deserno
Department of Medical InformaticsUniklinik RWTH Aachen University
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Content
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Macro
Open source packages
Commercial packages
Full scale
Server-side components
Additional application server
Micro
Hardware support
Web services
Nano
Workflowlevel
Scriptinglevel
Intro
Person
University
Department
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City of Aachen, Germany
BC:
Roman city
hot springs
800:
Charlemagne crowned
1st German Emperor
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City of Aachen, Germany
BC:
Roman city
hot springs
800:
Charlemagne crowned
1st German Emperor
Today:
Center of Europe
< 60 min: 3 airports
< 2 hrs: Paris
< 4 hrs: London
AACHEN
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RWTH Aachen University
1870: funded as poly-technical school
1890: right to give doctor degree (PhD)
Today:
German “Excellence” university
40,375 Students (WT 2013)
9,000 Mechanical engineering
Electrical engineering
Civic engineering
Material sciences
Natural sciences (computer science)
2,600 Medicine (100 faculty; 1,500 bedside patients)
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RWTH Aachen: What is Unique?
Engineering meets medicine
Drugs & medical devices
Biomaterials & implants
Medical informatics
Exceptional academic careers
5 Nobel laureates
…
Thomas M. Deserno (né Lehmann)
MSc electrical engineering
PhD computer science
PhD theoretic medicine (not a physician)
Image & data management Peter Debye
Chemistry 1936
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RWTH Aachen: Interconnections
Clinical Trial Center Aachen (CTC-A)
Established November 2010
Unit of medical faculty
Increase quality & efficiency in clinical trials
Provide IT tools
Department of Medical Informatics
Part of medical faculty
Research & teaching
Structure of Cooperation
IT Center RWTH Aachen (RKZ)
IT Department Uniklinik (UKA)CTC-A IMI RKZ
beauftragt beauftragt
UKA
berät
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IT Development for CTC-A
CTC-A
IMI
RKZ
Internet
Browser
Studymanagem.
(GWT)
Personal
ID
Access
protocol
Study
admin
Ausbaustufen 1 & 2Ausbaustufe 3Ausbaustufe 4
Stufe 5
Backup
(TSM)
Backup
(TSM)
Backup
(TSM)
Backup
(TSM)
eCRFs
Medical Data
(Open Clinica)
Pseudonymizer
(TMF PID)
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CTC-A: CTMS Data (06/15/14)
1.144 Monitored Trials
316 Recruting, active not-recruting
250 Pre clinical projects
810 Persons
430 Departments
194 Active user
73.907 Efforts
103.722 Hours
95 Users
7.417 Subjects
1.126 Documents
1.033 Latest version 11
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CTC-A: OC Instances
Mono-center trials
Diastolic Dysfunction
Paradise
PeRepair
Multi-center trials
SAS / BC
Rivaroxaban
LinaPlaque
EVIE
VitaVasK
CT imaging & viewing
EFSD
Holter recording & analysis
Registry
Cardio Biobank Registry
Registry / trial combination
MPN Registry
RuxoBeat trial
Closed
Mg2+ bei CKD
ProAir
Toothbrush
photography & analysis
CPT
double photography &
image processing
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Workflow: eCRF Development
Problem
Incomplete information (units, rage checks, rules)
Paper to eCRF
eCRF from scratch
Not modular
Re-use of modules
Solution
Physicians excel sheet
Short documentation
Default modules
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2. Nano Extenisons
2.2
2.1
2.
Workflow level
eCRF development
Scripting level
Multiple columns
Slider bar
Multiple image handling
Body region coding
Password-secured entry
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Scripting Level
Browser independency
Tools used
JavaScript
Runtime function calls
Bounding jQuery
Pop-ups
jQuery
JavaScript library
Part of OC
NoScript
Security
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Multiple Columns
Problem
Checkbox alignment
Horizontal or
Vertical
Solution
Style sheet patch CSS
Crop left item text field
Features
Save space
Simulate paper CRF
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Slider Bar
Problem
Radio Buttons
Hard to read, potentially large
OC slider bar
Static
Solution
HTML 5 slider bar
Features
Slider follows mouse
Numbers update while sliding
Slider initialization (both ways)
Supports “mouse over” events
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Multiple Image Handling
Problem
Only 1 image supported
Image shown after form is saved (tab is closed)
Solution
Generate unique ID (based on class)
Allow multiple instances on page
Add listener (OC independent)
Features
Update on change of input field
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Body Region Coding
Problem
Image-based markups
on standardized questionnaires
Pain
Quality of Life
Solution
Multiple overlay of transparent images
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Password-Secured Entry
Problem
Restrict access to input
Only a radiologist is allowed to enter data in certain fields
Solution
Replace HTML input field
Initial type: text
New type: password
Process by OC rules
Features
Hashed (fixed length)
Password never stored or visible
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3. Micro Extensions
3.2
3.1
3.
Additional Hardware
Barcode reader
Web Services
Study & Site
instantiation
User / Access / Role
Subject enrolment
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Additional Hardware
Problem
CR / LF sequence
Solution
Hidden text field
Processing rule
Supports
Bar code reader
Smartphone apps
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Web Services (WS)
Problem
CTMS and EDC disconnected (stand alone system)
Double entry of study meta data (study, sites, persons, …)
Solution
Additional endpoints
Mapping
EDC access model
CTMS access model
Functional integration
Single sign on
Access token
(system generated)
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existend
new
ListAll (Study)
GetMetaData (Study)
Create (Study)
AddUser (Study)
Create (Site)
Create (User)
ListAll (User)
ListAll (Patients)
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3. Micro Extensions
3.2
3.1
3.3
3.
Additional Hardware
Barcode reader
Web Services
Study & Site
instantiation
User / Access / Role
Subject enrolment
Hardware & Web Services
OC ToGo (camera support for direct imaging)
OC Tab (tablet support for offline data entry)
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OC ToGo
Idea
Direct image integration from mobile devices
Avoid data storage on device (privacy)
Solution
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OC Tab
Problem
Questionnaires filled by patients
Bed-side data capture (offline eCRF)
Solution
ODM-based data transfer
Generic model (data types)
Number
Text
Radiobutton, checkbox, combobox
Missing (so far)
Support for all the extensions presented
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4. Full Scale Extensions
4.1
4.
Server-side components
Unit calculator
Email support
Auto-hashing
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Unit Calculator
Problem (multi-center study)
Different guidelines
Different device
Different units
Solution
SQL
Standardized unit database
Linked to the eCRF
Features
Extensible
Support of long time studies
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Email Support
Problem
Automating system mails fitting the workflow
Example: Availability of image data for reading
Solution
JavaScript & PHP
Sendmail (mail server)
Postfix (mail transfer agent)
Features
Generates message and header
Metadata in web page
User-changeable text & recipients
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Auto Hashing
Problem
Encrypting personal identifiers
Example: Bar code scan of HIS ID
Solution
JavaScript & PHP
Simple block cipher XTEA
Features
Encryption with salt
Decryption
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4. Full Scale Extensions
4.24.1
4.
Server-side components
Unit calculator
Email support
Auto-hashing
Additional
application server
Image processing
Randomization
De-identification
(Pseudonym generation)
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Additional Application Server
Problem
Narrow scope of OC
Missing components
Solution
Take advantage of CTC-A GWT application server
Communication via Web Services
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Additional Application Server
put
Application
Server
TMF PID CTMS R
Open Clinica
RandomizorDe-
Identificator
User
SQL
SQL SQL
WS
SSO
JRIC++
Google Web Toolkit
Standard Query Language
Proprietary System
Interfaces
Single Sign On
Web Service
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System Architecture
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Additional Application Server
System Integration
CTC-A
Study selection
Meta data transfer
Image processing
OpenClinica
Subject selection
Image upload & display
Remote procedure calls
Measure & data entry
Features
Single sign on
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OpenClinica ServerGWT Application Server
FileSystem
Server
Client
Server
JAXWS
Client
Server
JAXWS
OCCore
OCWS
ExtGWT ApplicationExtGWT Application
SFTP
Java Image AnalysisJava Image Analysis
JavaScript
Excel eCRF
Internet
SOAP
DataBase
DataBase
FileSystem
MySQLPostgre
SQL
FTP FTPClient Serverput
get
OC-Big
PHP Proxy
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OC Big
Problem
Limited files: 1 per tab
Limited size: max. 10 MB
Solution
JavaScript & PHP
OC sources not modified
Open source packages
jQuery file upload
zip.js compression
OC style sheets (visual integration)
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OC Big
Features
Multiple files per tab
Drag & drop
Context links
Large data size
Limited only by disk space
Automatic chunking
Secure transfer
No timeout / 4 GB limits
Optional compression
Context: filenames include study and patient ID
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OC Data Importer
Problem
Data import from non-ODM applications
Example: Biobank data
Solution
External program with GUI (Java)
Maps data to OC identifiers
Features
Input: ODM (structure), Excel or CSV (data)
Output: ODM or SQL (structure & data)
Range checks
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5. Macro Extensions
5.2
5.1
5.
Open Source Packages
OC Big
OC Data Importer
Commercial Packages
Smart Clinica
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SmartClinica (Wega AG, Austria)
Problem
Cumbersome workflow
Action-intensive use
Solution
OC source code modification
Features
Study nurse view
Data manager view
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SmartClinica: Study Nurse
All functions in one view
Administration
Study / site
Personal data
Language
Subjects
Assess matrix
Add subjects
Automatic schedule
Notes &
discrepancies
Manage queries
Validation checks
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SmartClinica: Data Manager
Additional functionality
Study reports (per site)
Patient recruitment
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SmartClinica: Data Manager
Additional functionality
Study reports (per site)
Patient recruitment
Query status
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SmartClinica: Data Manager
Additional functionality
Study reports (per site)
Patient recruitment
Query status
Query response times
Allowed
Observed
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SmartClinica: Data Manager
Additional functionality
Study reports (per site)
Patient recruitment
Query status
Query response times
Allowed
Observed
OC administration
Export
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Summary
Web Services
ODM
Source Code Modification
Sendmail
Postfix
PHP
SQL.
Style Sheet
(CSS)
JavaScript
jQuery
Functionality
Usability
Interoperability
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Modularization
OC core
OC web services (client)
OC renderer (layout)
OC data types
(slider bars, click-on images)
OC rules
OC languages
Standardization
System interfaces
CDISC ODM
MySQL vs. PostgerSQL
Integration
Reporting
Radomization
DCIOM viewer
De-identification
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OC’s Future
©
Thank YouThomas M. Deserno
Department of Medical InformaticsUniklinik RWTH Aachen University
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