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

Tracks the patient schedule throughout the study

Patient visits the Physician

Eligibility is verifiedand patient is registered to a study

Lab Viewer

Identifies labs, loadsthem into the CDMSand AE system

Clinical data is captured

Cancer Central ClinicalParticipant Registry (C3PR v2)

Patient Study Calendar(PSC)

OpenClinica

Cancer Adverse EventReporting System (caAERS)

Identifies and tracks adverseevents and any associatedschedule changes

caBIG Hub

CALAEGSCTCAE v3

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.

12

OpenClinica – Open Source Trial Data Management

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

LAB, Radiology etc.

HL7 order1- ICD-9 with safety codes(if applicable)

EMR

HL7 order

Hospital and professional

Billing

1- activity performed2- participant account number with plan code3- charge type R, C, I, CNMS etc.

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