# Presentation: 533658

## caBIG Clinical Trials Suite (CCTS) The project formally known as CTMSi

***Project Overview***

- Patrick McConnell
- Duke Comprehensive Cancer Centerpatrick.mcconnell@duke.edu

## Agenda

**Project introduction/status (5 min – Peter Covitz)**
**Background (10 min)**
- CTMS overview, applications, vision, objectives, use cases
**Demonstration (15 min)**
**Architecture (10 min)**
- Architecture, ESB, security, user interface, phase 2
**Questions/discussion (20 min)**

## BackgroundClinical Trials Workflow

*Calendar reviewed and*
* **next visit scheduled also*
*identifies all the labs that*
* **should have been completed*

*Pt. eligibility is verified*
*and registered to a Study*

**Exchanging Data**

**Lab Viewer**

*Identifies which labs *
*are to be loaded in *
*CTMS*

*Entering the patient*
*data in local CTMS*

**Background**Clinical Trials Workflow

**Cancer Central Clinical**
**Participant Registry (C3PR v2)**

**Patient Study Calendar (PSC)**

**Clinical Trial Data**
**Management Systems (C3D)**

**Cancer Adverse Event**
**Reporting System (caAERS)**

*Identifying the Adverse Events*
*and any associated*
*schedule changes*

## BackgroundcaBIG CTMS Applications

**C3PR **(Cancer Central Clinical Participant Registry)
- Subjects registered to open, accruing trials
- Tracks consent, eligibility, stratification, randomization
**CDMS (Clinical Data Management System)**
- Electronic data capture (EDC) of clinical data
- Current caBIG interoperability with C3D (Cancer Central Clinical Database)
**CTOM/LabViewer **(Clinical Trials Object Model)
- Houses clinical data, including lab data
- LabViewer built to support the CTMS Suite
**PSC **(Patient Study Calendar)
- Tracks patients through the study
- Captures study events, such as treatment and lab tests
**caAERS **(Cancer Adverse Events Reporting System)
- Manages adverse events for subjects on a study

## BackgroundWhat are clinical trials applications trying to achieve?

**Facilitate the **_**planning**_** and instantiation of clinical trials, (and their **_**monitoring**_** of trials once they are instantiated)**
**Facilitate the **_**conduct **_**of clinical trials**
**Facilitate the **_**reporting and sharing**_** of clinical trial data to existing/new destinations, **
**Achieve **_**interoperability**_
- Increase the ability of systems to *access *and* use* the data and functionality of other systems
- Facilitate the integration of new sources and destinations of data

## BackgroundCTMS Suite overarching vision

**To provide a framework for coordinating the semantic and computational integration of applications currently under development within the CTMS workspace**
*Note:  Additional applications from within and from outside of CTMS WS may also be added to the CTMSi scope.*
**To develop and release a production-level CTMS application suite**

## BackgroundInteroperability relations

- Applications within an
- organization (or virtual org)

- Organization and its
- sponsors and regulators

- Organization and its peers
- in the research community

## BackgroundObjectives

**Phase 1: 12/2006-2/2007 (2 months)**
***Develop*** basic framework to enable interoperability among applications within CTMS WS
- C3PR, C3D, caAERS, caXchange/CTOM, PSC
***Demonstrate*** (in working code) a handful of high-value, real-world clinical scenarios at the 2007 caBIG Annual Meeting
**Phase 2: timeline uncertain – probably 5/2007-2/2008 (9 months)**
***Leverage*** and ***extend*** phase 1 work wherever possible
- Similar project framework, methodology, team, and collaborative structure
- Architectural baseline
***Develop*** clinical trials workflow use cases
- Possibly include additional applications
- PATS (Lite), Firebird, caMATCH
***Release*** a production-level interoperable CTMS suite of applications that cancer centers and other organizations will want to adopt and use

## BackgroundPhase 1 team members

**Project Director:**
- Meg Gronvall (BAH)
- Charles N. Mead, M.D. (BAH)
**NCICB CTMS Lead:**
- Christo Andonyadis, D.Sc. (NCICB)
- John Speakman (NCICB)
**Project Manager:**
- Edmond Mulaire (SemanticBits)
**Project Architects:**
- Patrick McConnell (Duke)
- Niket Parikh (BAH)
**Analysts:**
- Smita Hastak (ScenPro)
- Wendy Ver Hoef (ScenPro)
**Subject Matter Experts:**
- Sharon Elcombe (Mayo Clinic)
- Vijaya Chadaram (Duke)
- Jomol Mathew (Dana-Farber)
- Renee Webb (Northwestern)
**NCICB Systems Support:**
- Gavin Brennan (TerpSys), Vanessa
- Caldwell (TerpSys), Doug Kanoza (TerpSys),
- Wei Lu (TerpSys), Ralph Rutherford (TerpSys)

**Project Technical Leads:**
- Ram Chilukuri (SemanticBits)
- Charles Griffin (Ekagra)
- Vinay Kumar (SemanticBits)
- Stephen Reckford (Nortel Government Solutions)
- Rhett Sutphin (Northwestern)
- Sean Whitaker (Northwestern)
**caAERS**: Ram Chilukuri (SemanticBits), Krikor Krumlian
- (Akaza Research), Vinay Kumar (SemanticBits), Rhett
- Sutphin (Northwestern), Kulasekaran Sethumadhavan
- (SemanticBits), Sujith Thayylithodi (SemanticBits)
**caGrid**: Manav Kher (SemanticBits), Vinay Kumar
- (SemanticBits), Joshua Phillips (SemanticBits)
**caXchange (Lab Viewer/CTOM)**: Charles Griffin
- (Ekagra), Smita Hastak (ScenPro), Mukesh Mediratta
- (Ekagra), Kunal Modi (Ekagra), Wendy Ver Hoef
- (ScenPro)
**caXchange Extensions**: Ekagra, SemanticBits
**C3D**: Srinivas Batchu (Ekagra), Patrick Conrad (Ekagra),
- Rangaraju Gadiraju (Ekagra), Stephen Reckford (Nortel)
**C3PR**: Kruttik Aggarwal (SemanticBits), Ram Chilukuri
- (SemanticBits), Ramakrishna Gundala (SemanticBits),
- Manav Kher (SemanticBits), Patrick McConnell (Duke), Priyatam Mudivarti (SemanticBits)
**PSC**: Rhett Sutphin (Northwestern), Sean Whitaker
- (Northwestern)

## BackgroundPhase 2 team

**Product Owner: **John Speakman
**BAH/NCI direction: **Charlie Mead, Christo Andonyadis
**Project Manager: **Edmond Mulaire
**Architect Team: **Patrick McConnell, Niket Parikh, Anand Basu
**Analysts: **Smita Hastak, Wendy Verhoef
**SMEs: **Sharon Elcombe, Vijaya Chadaram
**Developers: **C3PR, caAERS, PSC, caXchange

## BackgroundPhase 1 use case scenarios

**Implemented scenarios**
- Enroll Subjects
- Load Lab Data in CDMS
- AE Triggered Schedule Change
**Non-implemented scenarios**
- Re-Consent Subjects
- Identify Potential Dose Change
- Quantify CRA Workload
- Study Specific AE/SAE Summary
- Cross Study AE/SAE Summary
- Extract Data for Interim Analysis

## BackgroundPhase 1 scenarios

- C3D

- LabViewer

- PSC

- caAERS

- C3PR

**1. Enroll Subject**

- C3D

- LabViewer

**2. Load Lab Data****into CDMS **

**3. AE Triggered ****Schedule Change**

- caAERS

- LabViewer

- PSC

## BackgroundDemonstration prototype

***BRIDG***

## caBIG Clinical Trials Suite (CCTS) The project formally known as CTMSi

***Demonstration***

## caBIG Clinical Trials Suite (CCTS) The project formally known as CTMSi

***Architecture***

## ArchitectureTypes of interoperability

**Messaging**
- Exchange data between applications
- Reduce double/triple/N data entry
**Security**
- Authentication, authentication, communication, delegation, SSO
- Single Sign-On: login with institutional credentials once for multiple applications
**User interface**
- Common look-and-feel
- Cross-application functionality
**Reporting**
- Cross-application data access and presentation

## ArchitectureOverview of phase 1 architecture

** ****caGrid**

** ****Enterprise Service Bus**

- GTS

- Dorian

- Grid Grouper

- InboundBindingComponent

- OutboundBindingComponent

*Routing Rules*

- Messages

- AuthenticationTrustAuthorization

**CCTS**

## Architecture - MessagingGrid service binding component

**Architecture - Messaging**Grid service binding component

**PSC **
**Grid Service**

**caAERS **
**Grid Service**

- ESB

- JMS IN Queue

- JMS OUT Queue

- Router

## Architecture - MessagingWeb service component

- ESB

## Architecture - MessagingMessage routing

## Architecture - MessagingMessage semantics: BRIDG

**Subject**

**Site**

**Study**

**Lab**

**AE**

## Architecture - Messaging Message syntactics: registration schema

**Subject**

**Site**

**Study**

## Architecture - SecurityPhase 1 single sign-on (SSO)

**Architecture - Security**Phase 1 single sign-on (SSO)

- SSO Module

- SSO Module

- SSO Module

- Login Page

- Application
- pages

- Application
- pages

- Application
- pages

- C3PR Web App

- caAERS Web App

- PSC Web App

- Validation of Grid Proxy

**Authentication Service**

**Dorian Service**

- Validation of Grid Proxy

## Architecture  - Security Phase 2 Single Sign-On (SSO) & Delegation

## Architecture – User InterfaceUser interface interoperability

**Motivation**
- "No man land" scenarios: functionality that doesn’t belong in a single app.
- Common look-and-feel
- Facilitate clinical trials workflows
- Sophisticated interactions between user interface components
**Potential solutions**
- Hot-links
- Common look-and-feel
- Portal
- Technologies: Liferay, JBoss Portal, Grid Sphere, Jetspeed w/ Pluto
- Standards: WSRP, HTML, iFrames, Portlet Bridge, JSR 286
**Timeline**
- Phase 2+

## Architecture – Looking ForwardPotential Phase 2+ Architecture

**Architecture – Looking Forward**Potential Phase 2+ Architecture

** ****Enterprise ****Service Bus**

- InboundBindingComponents

- OutboundBindingComponent

- BRIDG XML

- AuthenticationTrustAuthorizationSingle sign-on
- Delegation

- GridService

- Legacy API

- HL7 v3

- Legacy XML

- GridService

- Legacy API

- Portlet

** ****caGrid Security**

- GTS

- Dorian

- Grid Grouper

- Delegation Svc

- SSO App

- Federated Query
- Workflow
- etc.

**...**

*Routing Rules*

*Transformations*

## ArchitectureGovernance (Draft)

## ArchitectureResources

**Wiki**
- http://ctmsi.duhs.duke.edu/ctmsiwiki/*soon to be http://ccts.duhs.duke.edu/cctswiki/*
**GForge**
- https://gforge.nci.nih.gov/projects/ctmsintegration/*soon to be https://gforge.nci.nih.gov/projects/ccts/*

## ArchitectureThings to think about

**New core architecture components**
- ESB, portal, common LAF
**ESB delegation**
- Single component that acts on the behalf of multiple users
**BRIDG-based semantics**
- Mentoring, silver review, mapping to HL7
**HL7 complex datatypes**
- Implementation, caGrid data service queries
**Common repository of shared components**
- ctms-commons
**DSIC issues**
- CCTS will be grid-enabled
**Governance**
- How does CCTS governance play into XCWS governance?
**Cross-domain application SSO**
- SSO across CTMS, ICR, TBPT, Imaging
**Cross-domain governance**
- Passing data between cross-domain applications

## CTMS Interoperability Project 

***Backup Slides***

## BackgroundA collaborative effort in phase 1

**11 Organizations**
**Booz Allen Hamilton**
**Dana-Farber**
**Duke University**
**Ekagra**
**Harvard University**
**Mayo Clinic**
**NCICB**
**Nortel Government Solutions**
**Northwestern University**
**ScenPro**
**SemanticBits**
**8 Locations**
**Maryland**
**Minnesota**
**Virginia**
**Georgia**
**Massachusetts**
**North Carolina**
**Illinois**
**France**

**35+ Team Members / 5 Applications**
**Cancer Central Clinical Participant Registry (C3PR)**
**Cancer Central Clinical Database (C3D)**
**Patient Study Calendar (PSC)**
**caXchange: LabViewer and the Clinical Trials Object Model (CTOM)**
**Cancer Adverse Events Reporting System (caAERS)**
**8 Roles**
**Analysts**
**Architects**
**Developers**
**Project Director**
**Project Manager**
**Project Sponsor**
**Project Tech Leads**
**Subject Matter Experts**

## BackgroundTeam structure

- Direction

- Management

- Architects

- SMEs

- Analysts

- ProjectSchedule

**...**

- CommonSoftwareLibraries

- CTMSApplications

**CTMSi Team**

- CTMSiVision

- Scenarios

- Use Cases

- AnalysisModels

- CTMSiArchitecture

- CTMSGovernance

## ArchitecturePhase 2+ architectural decisions

**Messaging**
- Semantics
- BRIDG registered in caDSR/EVS
- Syntactics
- Grid requires XML
- Data structure: caCORE SDK-based, BRIDG-based, HL7 v3
**Security**
- caGrid security infrastructure
- DSIC implications: exposing grid services outside the firewall
**User interface**
- To portal or not to portal
- Level of support for each application
**Reporting**
- Some phase 2 use cases call for cross-application reporting

## CTMS Interoperability ProjectcaGrid security

**CTMS Interoperability Project**caGrid security

**Authenticate with **
**Local Credential Provider**

**SAML Assertion**

**SAML Assertion**

**Grid **
**Credentials**

**Grid **
**Credentials**

**Should I trust the**
**credential signer?**

**Is **
**Authorized?**

**Is member of?**

## ArchitectureDeployment environment for DEV/QA

## CTMS Interoperability ProjectEnroll patient

## CTMS Interoperability ProjectLoad lab data

## CTMS Interoperability ProjectAdverse Event triggered modification

## CTMS Interoperability Project 

***Backup Slides: Flavor of the Demonstration***

## 
Scenario 1 – Enroll Subjects

Scenario 2 – Load Lab Data in CTMS

Scenario 3 – AE Triggered Schedule Modification

- Scenario 1 – Enroll Subjects
- Scenario 2 – Load Lab Data in CTMS
- Scenario 3 – AE Triggered Schedule Modification

**Flavor of the demonstration**Implemented scenarios

## CTMS Interoperability ProjectTech demo contingency slides

**Subject registration kicks ****off the whole process**

## CTMS Interoperability ProjectTech demo contingency slides

**Hot-links allow ****inter-application navigation**** **

**Registration propagated to****C3D, PSC, LabViewer, caAERS**

## CTMS Interoperability ProjectTech demo contingency slides

**Hot-links take you directly ****to the subject**

**Hot-links allow ****inter-application navigation**

**Calendar created ****automatically for subject ****from registration message**

## CTMS Interoperability ProjectTech demo contingency slides

**Lab sent to ****caAERS for an AE**

**Hot-links allow ****inter-application navigation**

## CTMS Interoperability ProjectTech demo contingency slides

**Out of range labs****are highlighted**

**Selected labs are ****loaded to C3D**

## CTMS Interoperability ProjectTech demo contingency slides

**Rest of AE details ****need to be filled in**

## CTMS Interoperability ProjectTech demo contingency slides

**Notify study calendar that the ****AE may require a ****schedule change**

**Hot-links allow ****inter-application navigation**** **

## CTMS Interoperability ProjectTech demo contingency slides

**Notification generated ****from caAERS**

## Labs were sent from LabViewer

**Labs were sent from LabViewer**