1. Cancer Central Clinical Participant Registry (C3PR) v2.5 CTMS WS September 22, 2009 Pankaj Agarwal 1, Ram Chilukuri 2 1 Duke Comprehensive Cancer Center pankaj.agarwal@duke.edu 2 SemanticBits, LLC ram.chilukuri@semanticbits.com

2. C3PR Demonstration Who is involved in C3PR? Duke Bioinformatics Jamie Cuticchia (PI) Duke Information Systems Bob Annechiarico (co-PI) Pankaj Agarwal (PM) William Banks (domain expert) Seth Fehrs (developer) Arati Nemani (DBA, tester) Jeff Allred (IT manager) Duke Clinical Trials Vijaya Chadaram (domain expert) CALGB Kim Johnson (domain expert) Amish Shah (domain expert) Westat Steve Riordan (domain expert) Georgetown Jieping Li (domain expert) North Carolina State Patty Spears (patient advocate) Wake Forest Bob Morrell (domain expert) Don Babcock (Technical Expert) Lisa Dixon (SME) Claire Kimbrough (SME) Mayo Sharon Elcombe (domain expert) SemanticBits Patrick McConnell (architect) Ram Chilukuri (architect) Kruttik Aggarwal (lead developer) Ramakrishna Gundala (developer) Vinay Gangoli (developer) Vinay Kumar (analyst) Shilpa Alluru (QA tester) David Coffey (UI designer) Elizabeth Nobriga (tech writer) NCI Christo Andonyadis SAIC Nancy Roche Peter Yan

3. C3PR Demonstration Release Timelines C3PR Release 2.5.5 Developed by Duke Comprehensive Cancer Center. Extends the Release 2.5 functionality. Project began with development of Version 2.0 in November 2006. Release 2.0 in March 2008. Release 2.5 in September 2008. Currently working on Version 3.0 slated for release in November 2009.

4. C3PR Demonstration C3PR Overview Web-based application used for end-to-end registration of patients to clinical trials. Captures the consent signed date, eligibility criteria, stratification, randomization, and screening. Clinical workflows are enabled by subject and study-site centric views into the registration process. Registration details are captured for all types of studies including companion studies, such as quality of life and tissue banking studies. C3PR can be run in a standalone mode or in an integrated mode with the caBIG Clinical Trials Suite (CCTS). C3PR also enables multi-site clinical trials where study definitions are shared from the coordinating site to the participating sites. C3PR integrates with the NCI Enterprise Services to insure that the latest Persons, Organizations, and Studies are present in the system and displayed to the user. Summary 3 Reporting capability.

5. C3PR Demonstration Enterprise Services CCTS Release (Nov/Dec 2009) Integration with Person, Organization and Protocol Abstraction (read only). Future implementation Create and update for Person, Organization, and PA. Development of Subject and Registration services. Integration with other services that are developed (e.g. Accrual service). Enhancement of PA, including study versions/amendments.

6. C3PR Demonstration CCTS Integration CCTS Release (Nov/Dec 2009) BDA: completion of automated build and deployment. Compliance with CCTS 1.1 interoperability (registration and study exchange). Future work BDA: automated testing, including integration tests. CCTS Portal. Message refactoring. Service refactoring.

7. C3PR Demonstration C3PR-specific Features CCTS Release (Nov/Dec 2009) Study versions, including backdated registrations and consent versions. Multiple consents. Summary 3. ICD-9. Multi-site pilot. Future work OPEN integration. Custom fields. Multi-site enhancement, including amendments. EHR/EMR Integration. Call-out randomization. Basic science eligibility criteria. Flexible Reporting. Multiple registrations of one subject to the same trial.

8. C3PR Demonstration Standards and Compliance Support Meet FDA Regulations. Harmonize with BRIDG model version 2.x Harmonize with BAM process model version 1.0 Maintain caBIG SLC certification.

9. C3PR Demonstration Community Outreach Interaction with CTMS and other Workspaces. Interaction with Adopters to facilitate adoption. Enterprise Support. Interface with KC Provide: Updated documentation Release information Version updates Source code repository. Prioritize enhancements to C3PR