NCI Enterprise

Services (aka COPPA)

CTRP and the Suite

March 19, 2009

Outline

• COPPA Overview

• Models – Service Overview

• HL7 RIM Model

• BRIDG Model

• COPPA Analysis Model

• COPPA Information Model

• COPPA Functional Model

• Demo

• Path Forward

• Resources

COPPA Overview

COPPA is 4 Core Services, their dependencies, and the architecture to allow for various implementations

• Correlations

• Organizations,

• Persons,

• and Protocol Abstractions

!!!Really COPPA is really more than 4 services!!!

COPPA Scope and Reality

• Initial Scope: COPPA will create an application that satisfies the regulatory requirements surrounding Protocol Registration, as well as 4 Entity Services (Person, Organization, Protocol Abstraction, and their Correlations).

• Enter CTRP: As a core project COPPA has struck a chord with the enterprise and, depending on one’s perspective, COPPA means much more than the Jan 5, 2008 deliverable of the initial scope.

• COPPA Has People Communicating: Using the core concepts of service oriented architectures (SOA) and the specification methodologies employed by the NCI, COPPA has been influential in opening communication throughout the enterprise.

• Clinical Trials Suite (CCTS): COPPA services are just the beginning of NCI Enterprise Services. The Suite will use and build on the existing services. It is very clear that higher level services will ultimately be needed.

COPPA Positioning

• Within the domain of protocol driven clinical trials, three concepts form a foundation. These include: Person, Organization, and Protocol. These three entities participate in and underlie the majority of semantics, both dynamic and static, that form the essence of this domain.

Person

Protocol

Organization

COPPA Positioning (3)

• Furthermore, these three entities are rarely referenced directly within business cases and deployment contexts. Rather, their correlations with each other are in the shape of structural and functional roles. These roles, in turn, appear in business cases that span many usage contexts, and require durability and persistence quite apart from any particular application’s implementation.

Person

Protocol

Organization

Structural

Functional Functional

Key Needs (2)

Need Priority Concern Current Solution

Proposed Solution

Manage Protocol Abstractions

Highest There is not a way to manage Protocol Abstractions that satisfies regulatory and policy requirements

Partial solutions exist with CTEP

The NCI Protocol Portal will identify protocol abstractions and correlate between them and the associated persons and organizations

Correlate between representations of Protocol Abstractions

High The representations of a protocol are currently tied to several use cases, though they represent the same identifiable protocol entity

N / A Loosely couple the representation of a protocol abstraction to the identifiable protocol

Manage Entities Medium Persons, Organizations, and Protocol Abstractions represent three key integration points for the NCI

N / A Manage each entity with its own service, allowing flexible integration strategies

Key Needs (2)

Need Priority Concern Current Solution

Proposed Solution

Flexible and Durable

High Integrating with 65+ cancer centers will require much time and effort for <<just>> fundamental concepts

None Manage entities using functionally consistent services that “flatten” entity representation into trait sets

Relationships between entities need to be visible across the domain

High Without enterprise visibility of relationships, enterprise reporting and analysis is not possible

Central Data stores, policy driven workflows

Central control of relationship management that is loosely coupled to entity management

Relationships between similar entities can vary across the domain

Medium Individuals occupy different roles, as do organizations. Security is not statically tied to entities

Individual applications, local deployments

Central control of relationship management that is loosely coupled to entity management

Capabilities

Benefit Supporting Features

Flexible, Reusable Entity Management Strategy

Flexible trait sets mapped to different persistence and usage models; creates loose coupling between service implementation and changing data representation; provides integration and migration strategy with trading partners

Separate Entity Management from Correlation Management

Allows security to be implemented according to variable roles in varying deployment contexts; provides clear migration / integration path with legacy systems

Visibility of Relationships to all relevant applications

Allow each application to define granular security requirements based on global relationships.

Layered Models

Domain Analysis Model

Project Analysis Model

Information Model

Implementable/Functional Model

Platform Model

Implementation

Platform Model

Implementation

Platform Model

Implementation

MAKE NO MISTAKEThe primary goal is

to get here

HL7 RIM

COPPA captures essential RIM Semantics

• Entities have only a single relationship with each other (Player / Scoper), though the Role (Structural Role) itself varies. Example: Healthcare Provider.

•Acts are the concepts of activities that will happen or have happened or should happen. For example: Study Protocol

•Roles are bound to activities (Acts) via a participation. For example: a PI is a Healthcare Provider bound to a study.

BRIDG Model:A Biomedical Research Integrated Domain Group

COPPA Analysis Model

COPPA Information Model:ISO Datatypes

COPPA Information Model

COPPA Functional Model

Quick CTRP Registry Demo

• Currently in production – since January 5th, 2009

• Limited to pilot sites• Early adopters scheduled to be added soon• Amendments to be support in next release• Accruals coming soon• Outcomes after Accruals• Generates XML file for submission to Clinical

Trials.gov

NCI Clinical Trials Reporting Program Search Submitted Clinical Trials

NCI Clinical Trials Reporting Program Register Trial

NCI Clinical Trials Reporting Program Search Organizations

Select Organization

Add Organization

Add Organization Fields

Trial Status Fields

Path Forward

• Expand on COPPA Services (in no particular order)

• Schedule

• Agent

• Disease

• Registration

• AE

• Treatment

• Change name to NCI Enterprise Services (NES)

• Instead of COPPASADRAT

• Integrate CTMS Suite with NES – starting with April 2009 release

• Follow Process

• Follow Governance

• Improve Interoperability

Resources

• COPPA Model Source:

• https://gforge.nci.nih.gov/svnroot/coppa/trunk/documents/

• COPPA Model Published:

• http://www.ncientarch.info/coppa/logical_model/

• COPPA Wiki

• https://wiki.nci.nih.gov/display/CTMS/COPPA+Core+Services

• CTRP Website

• http://www.cancer.gov/ncictrp/allpages

• CTRP Registry

• https://trials.nci.nih.gov/registry/home.action

• CTPR Registry Demo

• http://ctrp.nci.nih.gov/CTRPv1.0_Tutorial.swf