# Presentation: 943872

## The caBIG/HL7/CDISC Structured Protocol Representation

- Douglas B. Fridsma, MD, PhD
- Center for Biomedical Informatics
- Center for Pathology and Oncology Informatics
- University of Pittsburgh

## A Team Effort

**caBIG/HL7/caBIG SPR core modelers**
- Christo Andonyadis
- Greg Anglin
- Lisa Chatterjee
- Julie Evans
- Douglas B Fridsma
- Smita Hastak
- Ray Heimbuch
- Charlie Mead
- Joyce Niland
- John Speakman
- Cara Willoughby
- Diane Wold

**Leadership and collaboration**
- Sue Dubman, NCI
- Becky Kush, CDISC
- Linda Quade, HL7
**caPRI**
- Mike Becich
- Doug Fridsma
- Linda Schmandt
- Mike Davis
- Xuegong Wang
- Becky Boes
- Brenda Crocker
- Rebecca Crowley
- Valerie Monaco
- Bill Gross
- John Milnes
- Denine Maglicco

## Vision of the SPR SIG (from July 2004 face to face meeting)

- To *define* a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and *develop* *tools* that use these protocol representations. These tools should be standards-based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information.
- The clinical trials protocol representation will serve as a *foundation* for caBIG modules that support *all phases* of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements.
- At every stage, we will *evaluate* and *test* our work

## Vision of the SPR SIG (from July 2004 face to face meeting)

- To *define* a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and *develop* *tools* that use these protocol representations. These tools should be standards-based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information.
- The clinical trials protocol representation will serve as a *foundation* for caBIG modules that support *all phases* of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements.
- At every stage, we will *evaluate* and *test* our work

## caSPR: The comprehensive HL7/CDSIC/caBIG SPR model

## Why caBIG/CDISC/HL7?

- We used the CDISC protocol representation element “spreadsheet” as a starting point for our model development efforts
- caBIG has been involved with both CDISC and HL7
- January 2005, HL7 adopted our model as the Domain Analysis model for the RCRIM committee (Regulated Clinical Research)
- Recognizes that this is a collaborative effort
- CDISC DSAM = HL7 DAM = caSPR

## The Communication Pyramid

***Communication***

***Domain Experts***

***Technical Experts***

***Source: Charlie Mead, MD, HL7***

## The iterative process of creating the SPRStage One

- RIM

- Domain elements
- (drawn from CDISC
- PR elements)

- * at this stage there are granular ideas that we know we need to represent, but relationships not clear

- Business Inputs

## CDISC protocol elements

## Slide 10

## The iterative process of creating the SPRStage Three [ = state at March 2005 ]

- Business Inputs

- RIM

- reductionist model of structure of domain elements

- * at this stage we analyze the model to boil it down to its primitive data structure.  It gets close to RIM, but very abstract ... loses some meaning to domain experts

## Entities and Roles

## Entities and Roles

## The iterative process of creating the SPRStage Two       Stage Three       Stage Four

*The iterative process of creating the SPR*Stage Two       Stage Three       Stage Four

## The iterative process of creating the SPRStage Four

- Business Inputs

- RIM

- integrated model(s) of structure of domain elements

- explode back to domain concepts, through instance diagrams, storyboards,vocabularies, and other tools
- Checking that the initial elements still hold in the model

## ECOG 2190 Schema

## ECOG 2190 Protocol Activity

## Vision of the SPR SIG (from July 2004 face to face meeting)

- To *define* a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and *develop* *tools* that use these protocol representations. These tools should be standards-based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information.
- The clinical trials protocol representation will serve as a *foundation* for caBIG modules that support *all phases* of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements.
- At every stage, we will *evaluate* and *test* our work

## caSPR forms the foundation for interoperable module development

## Proposed caPRI System Description

## Portions currently implemented

- EAV database

## Slide 22

**Notes:**
This is essentially an About box

## Slide 23

**Notes:**
Plugin Management

## Slide 24

**Notes:**
Form Management screen for making extensions and creating new forms

## Slide 25

**Notes:**
New Form Creation Wizard, with CDE selections

## Slide 26

**Notes:**
Query

## Slide 27

**Notes:**
Registration Form

## Slide 28

## Slide 29

## Poster Session at the Annual Meeting	

- caSPR
- caPRI
- Demonstration of the application

## Vision of the SPR SIG (from July 2004 face to face meeting)

- To *define* a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and *develop* *tools* that use these protocol representations. These tools should be standards-based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information.
- The clinical trials protocol representation will serve as a *foundation* for caBIG modules that support *all phases* of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements.
- At every stage, we will *evaluate* and *test* our work

## The Importance of Process

- Processes to develop interoperable applications
- Derived from the HL7 Development Framework
- Processes to develop interchange standards
- Can use the HL7 Development framework
- Processes to maintain the SPR
- Developing methods of collaboration and versioning control, based on open-source architectures and methods
- Developing methods of model harmonization based on HL7 frameworks
- We need the coordination mechanisms to let us all work together toward a common goal!

## caSPR forms the foundation for interoperable module development

- CT Registry Module

- Module Development

- caSPR Domain Analysis Model

- Internal
- Tracking
- Module

- AE
- Module

- Eligibility
- Module

- Statistical
- Module

- Financial
- Module

- Lab
- Module

- Financial
- Module

- Statistical
- Module

- Eligibility
- Module

- AE
- Module

- CT Registry Module

- Internal
- Tracking
- Module

- Lab
- Module

- CT Registry Module

- caSPR Domain Analysis Model

- Internal
- Tracking
- Module

- AE
- Module

- Eligibility
- Module

- Authoring
- Module

- Lab
- Module

- Financial
- Module

- Authoring
- Module

- Eligibility
- Module

- AE
- Module

- CT Registry Module

- Internal
- Tracking
- Module

- Lab
- Module

## A example development process—caPRI 

- caSPR =
- CDISC DSAM =
- HL7 DAM

- Increasing specificity and computability

- Application Development

- Interchange Specification

## A example development process—caPRI

- caDSR candidate CDEs

- caSPR module analysis model

- caSPR CDE

- caPRI input module (module specification)

- caSPR =
- CDISC DSAM =
- HL7 DAM

- Semantic connector & UML loader

- Increasing specificity and computability

- Functional Requirements

- Application Development

- Interchange Specification

## A example development process—caPRI

- caDSR candidate CDEs

- caSPR module analysis model

- caSPR CDE

- caPRI input module (module specification)

- RCRIM DMIM

- RMIM
- (interchange requirements)

- HL7 XSD (Interchange specification)

- caSPR =
- CDISC DSAM =
- HL7 DAM

- Semantic connector & UML loader

- Increasing specificity and computability

- Functional Requirements

- Application Development

- Interchange Specification

## A example development process—caPRI

- caDSR candidate CDEs

- caSPR module analysis model

- caSPR CDE

- caPRI input module (module specification)

- caPRI CT management framework

- RCRIM DMIM

- RMIM (interchange requirements)

- HL7 XSD (Interchange specification)

- HL7 compliant framework

- caSPR =
- CDISC DSAM =
- HL7 DAM

- Semantic connector & UML loader

- Increasing specificity and computability

- Functional Requirements

- Application Development

- Interchange Specification

## The Importance of Process

- Processes to develop interoperable applications
- Derived from the HL7 Development Framework
- Processes to develop interchange standards
- Can use the HL7 Development framework
- Processes to maintain the SPR
- Developing methods of collaboration and versioning control, based on open-source architectures and methods
- Developing methods of model harmonization based on HL7 frameworks

## The people processes

- Desiderata
- Open access for people to read and examine
- Open communication and discussion forums
- Mechanisms for proposing changes
- Mechanisms for harmonization
- Levels of access for readers, modelers, and stewards
- Tightly controlled versioning process with tracking
- Integration of model packages, application code, documentation, and user groups

## The People Processes

## Tools to Support the People Process

- Currently Piloting an installation of gForge
- Open source
- Used for projects like firefox and mozilla
- Bug and feature tracking
- Discussion forums
- Source control with CVS check-in/check-out
- Project administration
- Email and listservs with notification of code, discussion group, or document changes
- Ability to link and synchronize CVS repositories across sites

## Vision of the SPR SIG (from July 2004 face to face meeting)

- To *define* a computable protocol representation that supports the entire life-cycle of clinical trials protocol, and *develop* *tools* that use these protocol representations. These tools should be standards-based, caBIG compliant and assist users in creating, maintaining, and sharing clinical trials information.
- The clinical trials protocol representation will serve as a *foundation* for caBIG modules that support *all phases* of the clinical trials life cycle, (including protocol authoring) and be developed to meet user needs and requirements.
- At every stage, we will *evaluate* and *test* our work

## What have we accomplished?

- caSPR
- Established excellent collaboration with CDISC, HL7 and other caBIG modelers
- Constructed the initial pieces of a comprehensive model – still much to do
- Have established this model as the HL7 Domain analysis model
- Have established EA as the tool of choice, and moved the model from Rational Rose XDE into EA
- caPRI
- Demonstrated a caBIG compliant application that is modular, extensible, flexible, and driven off of the SPR model
- Set the stage for collaborative development of new modules and features
- Process
- Proposed a model development, collaboration, and version control process
- Currently piloting a website to support all aspects of model and application development
- caBIG and the SPR will be piloting the model maintenance and versioning processes

## The caFuture

## What we need

**Ask not what the structured protocol representation can do for you, **
**Ask what you can do for the structured protocol representation**

## Current caBIG/HL7/CDISC SPR needs

- Developing Instance diagrams, examples, and testing the model using the ECOG 2190 protocol as our initial test
- The model is “static” heavy
- Develop the behavioral portions of the model
- The people processes around clinical trials
- Calendars
- Activities
- Behaviors
- Study execution

## Priorities for the SPR (from last night)

- Storyboards (level 1 readers, story tellers)
- Determine eligibility
- Enroll a patient
- SIG involvement in 4-5 storyboards
- Others?
- Process descriptions, activity diagrams (level 2 modelers, story writers)
- Activity and state diagrams
- Use cases
- Harmonization (level 3, story leaders)
- Integrate across SIGs and workspaces
- Development of people processes and technology

## Opportunities for collaboration—caSPR 

- SIGs and projects
- Expand areas of the model with representations specific to the area of expertise
- AE
- Lab
- Reporting
- Individuals
- Assist in instance diagram development
- Develop behavioral models and business rules
- Assist in definition review and harmonization
- We ALL benefit from a SINGLE protocol representation for interoperability. This is it! Let’s all work together to make it happen!

## Next steps in the SPR project – our tasks

- caBIG/HL7/CDISC Structured Protocol Representation
- Dissemination and presentation—road show
- Presentation of the model to caBIG April 10th
- Presentation of the model to HL7 May 2nd
- Presentation of the model to CDISC middle/end of May
- Development and implementation of model versioning control and collaboration processes
- People and technical processes to be finalized
- gForge site beta to be moved to open access
- Need collaborators and testers of the site and model
- Incorporation of informal comments and correction of known model problems
- Next core modeling session end of May/early June

## Next steps in the SPR project

- Model development needs
- Review class and attribute definitions
- Assistance with instance diagrams and examples
- Requirements gathering for new functionality and subdomains
- New classes and attributes
- New areas around the life-cycle of the clinical trial protocol
- Application development needs
- Adopters of caPRI – testing and improvement
- Development of business rules and enhanced functionality
- Evaluation of the architecture – is the right approach?
- Developers of new modules
- Specification of UML classes, attributes and CDEs
- Early prototyping of applications and model extensions

## Next steps in the SPR project

- Integration within CTMS and across caBIG
- SIGs should be the leads in the requirements and testing of the parts of the model that they have expertise in
- AE
- Lab
- Reporting
- Financial
- Other workspaces activities will touch on the SPR
- Tissue banking and pathology tools
- Will need input from vocabulary, CDE, and architecture groups

## The Clinical Trial Lifecycle

- ResearchDevelopment

- Pre-Trial Setup

- PatientEnrollment

- PatientManagement

- Reporting &
- Administration

- Financial& Billing

- DataAnalysis

## The Clinical Trial Life Cycle

- Register protocol

- Pt eligibility determination

- Pt registration

- Summary 4 reporting

- Adverse event reporting

- CDUS reporting

- Patient Treatment calendar

- Budgeting calendar

- Trial results repository

- Custom report generation

- Internal tracking (IRB,PRC, fiscal, etc)

- CT registry to disseminate information

- Statistical analysis

- Custom case report forms

- Pt laboratory information

- Data mining

- Financial and billing information

- PI protocol authoring

- 1

- 8

- 7

- 6

- 5

- 4

- 3

- 2

- 13

- 12

- 11

- 10

- 9

## Let’s Get Busy!Fridsma@cbmi.pitt.edu caBIG.nci.nih.gov