1. NCI Enterprise Services (aka COPPA) CTRP and the Suite March 19, 2009

2. Outline COPPA Overview Models – Service Overview HL7 RIM Model BRIDG Model COPPA Analysis Model COPPA Information Model COPPA Functional Model Demo Path Forward Resources

3. COPPA Overview COPPA is 4 Core Services, their dependencies, and the architecture to allow for various implementations C orrelations O rganizations, P ersons, and P rotocol A bstractions !!!Really COPPA is really more than 4 services!!!

4. 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.

5. 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

6. 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

7. Key Needs (2) NeedPriorityConcernCurrent Solution Proposed Solution Manage Protocol Abstractions HighestThere 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 HighThe representations of a protocol are currently tied to several use cases, though they represent the same identifiable protocol entity N / ALoosely couple the representation of a protocol abstraction to the identifiable protocol Manage EntitiesMediumPersons, Organizations, and Protocol Abstractions represent three key integration points for the NCI N / AManage each entity with its own service, allowing flexible integration strategies

8. Key Needs (2) NeedPriorityConcernCurrent Solution Proposed Solution Flexible and Durable HighIntegrating with 65+ cancer centers will require much time and effort for > fundamental concepts NoneManage entities using functionally consistent services that “flatten” entity representation into trait sets Relationships between entities need to be visible across the domain HighWithout 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 MediumIndividuals occupy different roles, as do organizations. Security is not statically tied to entities Individual applications, local deployment s Central control of relationship management that is loosely coupled to entity management

9. Capabilities BenefitSupporting 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.

10. Layered Models Domain Analysis Model Project Analysis Model Information Model Implementable/Functional Model Platform Model Implementation Platform Model Implementation Platform Model Implementation MAKE NO MISTAKE The primary goal is to get here

11. 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.

12. BRIDG Model: A Biomedical Research Integrated Domain Group

13. COPPA Analysis Model

14. COPPA Information Model: ISO Datatypes

15. COPPA Information Model

16. COPPA Functional Model

17. Quick CTRP Registry Demo Currently in production – since January 5 th, 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

18. NCI Clinical Trials Reporting Program Search Submitted Clinical Trials

19. NCI Clinical Trials Reporting Program Register Trial

20. NCI Clinical Trials Reporting Program Search Organizations

21. Select Organization

22. Add Organization

23. Add Organization Fields

24. Trial Status Fields

25. 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

26. 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