SOA and

interoperability
for clinical
research
informatics

Umit Topaloglu Ph.D.

Disclaimer

• Yes we use caBIG tools in production

environment.

• We are happy with the progress and we will

continue making improvements and

implementations for remaining requirements.

Our goal-

3
Our options

• Buy a vendor product

• Develop in house

• Collaborate and reuse standards/open

source
 Our needs for clinical research

• PLT – in house development

• Protocol/IRB tool- in house development
• Budgeting tool- in house development
• Recruitment- in house development
• Participant registry- C3PR
• Study Calendar- PSC
• Labs/grading- Labviewer/CALAEGS (CTCAE V3)
• CDMS- OpenClinica
• Adverse Event- Pro-CTCAE/caAERS
Service Oriented Architecture

• Service-oriented architecture (SOA) is a

flexible set of design principles used during
the phases of systems development and
integration in computing. A system based
on a SOA will package functionality as a
suite of interoperable services that can be
used within multiple separate systems from
several business domains.
Wikipedia
(http://en.wikipedia.org/wiki/Service-
oriented_architecture)
Our approach

• We approached module by module to

address our informatics needs.

Due to:
• Minimize the adoption resistance.
• We started from most problematic area
• Minimize the time required to implement all
vs one (we have limited resource)
The Suite at UAMS
Cancer Central Clinical Patient Study Calendar
Participant Registry (C3PR v2) (PSC)

Tracks the patient schedule Lab Viewer

Eligibility is verified
throughout the study
and patient is registered
to a study

caBIG Hub
OpenClinica Identifies labs, loads
them into the CDMS
and AE system

Patient visits the

Cancer Adverse Event
Physician
Reporting System (caAERS)

Clinical data is captured CALAEGS

CTCAE v3
Identifies and tracks adverse
events and any associated
schedule changes
Study and Subject information

• Study
• Consents, Versions
• Eligibility
• Randomization/stratification
• Companion studies
• Subject
• Consent signed
• Arm and epoch (with dates)
• Identifiers
• Etc.
C3PR-study and subject service

• We have
• More than 160 studies
• More than 2,000 participant registered.

• We also use in
• Psychiatric Research Institute
• National Children's Study
Patient Study Calendar

• Detailed study calendar

• It can manage;
• all the study related activities
• The same study structure with C3PR
screening, treatment, follow up
• Activities imported from the IRB system with
“R”, “C”, “I” to represent what account the
activity should be charged.
OpenClinica
– Open Source Trial Data Management

12
Common Data Elements for CRFs

• It is a mandate that all the CRFs has to have

CDEs from caDSR in it.

• It is a time consuming commitment.

Other research data collection

• We have an online survey tool to let groups

to create and publish questionnaire
• We use LimeSurvey open source tool
• Limesurvey is using UAMS sign in

• Cancer Control is harmonizing the surveys

with CDE from caDSR.
• We‘ve completed Breast Moduler
Mammography curation (~300 questions)
Reporting and Data Access

• LimeSurvey and OpenClinica have in built

export functionality for statistical packages
(R etc.)

• We use SQL Server Reporting Server for

reports
• We can populate IRB Continuing Review
Report automatically
• Other administrative reports
BioSpecimen/gene expression
Management

We have
• caTissue Suite in our Tissue Bank in
production since December 2008
• Done some customization for our workflow

• caArray for affymatrix and working on

ilimuna
• Developed auto uploader/importer
Text Reports using caTIES

caTissue
I2B2- more than 300K reports
Data Quality

•We have used Common Data Elements to help us clean

population Science Data

•Information Quality

•Know what you have

•Clean the existing

•Prevent future repitition

Frequency analysis of the “RACE” category and
basic analyses of the SSN
Our Dream: where are we?

22
Current challenge-

•Solve/minimize Research Billing problems

• with the help of the Study Calendar.

•Challenge

•Complexity of issue

•Terminology conversion
Steps and Challenges

•Study budget is created using CPT codes

• supposedly in calendar template

•Convert CPT codes to SNOMED CT so clinic would

understand
•Office Visit is good example
•Terminology conversion

•Order/Billing using CPT

•Another conversion back to CPT from SNOMED
Budget
Activity States
PSC messages

PSC HL7 order

HL7 1- ICD-9 with safety codes(if
order applicable)

EMR LAB, Radiology etc.

1- activity performed
2- participant account number with plan code
3- charge type R, C, I, CNMS etc.

Hospital and
professional
Billing
When we finish

•We will know which research activities completed for which

patient and where to be charge

•Wrong charge research vs conventional problem will be

solved.
Questions

•Thanks for Listening

utopaloglu@uams.edu