1. Deploying caBIG ® at the IUSCC Ganesh Shankar ICR F2F Sept. 23-24, 2008

2. Indiana University Simon Cancer Center IUSCC is a matrix center IU School of Medicine University Hospital Riley Hospital Methodist Hospital 3400 new patients diagnosed per year 16,000 total patients per year Approx. 29 Clinical PIs and 97 Basic Science PIs

3. Deployment Goals Enable Bench-to-Bedside research Deploy application(s) from Life Sciences Distribution If appropriate, deploy application(s) from Clinical Trials Management Systems Bundle Share data Deploy caGrid node and connect to the NCI grid Lower legal barriers to data sharing by deploying Data Sharing and Security Framework tools

4. Deployment Process Self Assessment Where is the Center now? Infrastructure readiness Technology capability Staff and Investigator capability Institutional readiness Capability Analysis and Goals Where does the Center want to be? Implementation Plan How will the Center get there?

5. Self Assessment Appoint Deployment Lead Infrastructure Architectures deployed – SOA Depth of support – help desk, training, documentation Data standards – HL7, CDISC Hardware or network limitations IT capability Hardware and OS deployed Development languages Database

6. Self Assessment Staff/Investigator capability Types of Investigators What technology is used to support them? Institutional readiness Tackled strategic project recently? Communication between groups, programs Participation in Cooperative Groups Send completed Assessment to caBIG Advisory Center

7. Capability Assessment and Goals Capability assessment by caBIG AC and Deployment Lead. Determine goals Urgency Number of affected users Feasibility Local factors Deploy caGrid node by end of Sept. 2008.

8. Past and Current Challenges… IUSCC Center grant renewal Other initiatives ITRAC BSM CTSA Legal framework DSSF – strategic, incomplete at that time Legal Staff, Center for Bioethics

9. caBIG ® Tools Life Sciences Distribution Clinical Trials Compatibility Framework C3PR PSC caAERS caXchange CTODS caGrid Data Sharing and Security Framework caBIG ® -Compatibility achieved through caBIG® Bundles caArray caTissue caGWAS NCIA CTODS caGrid caBIG® Policies Processes and Best Practices Model Documents Trust Fabric

10. Two Pathways—Adopt or Adapt Adopting a tool involves installing software applications already created by caBIG®, integrating them into the workflow, and connecting to caGrid. Adapting a tool involves modifying the existing software applications to be caBIG® compatible and then connecting to caGrid. Interface from the Tool to the Grid

11. Which Tools are Already Deployed? Percipenz Oncore deployed as CTMS NCI AdEERS website sufficient IUSCC deploying Percipenz BioSpecimen Module for tissue bank data management

12. Milestones Year 1 Complete Assessment Develop Goals, Implementation Plan Deploy functional caGrid Node Year 2 Deploy LSD application - caArray Deploy integration capability – caAdapter, caXchange, CTODS Use DSSF to define how to share data with collaborators

13. Which Tools to Deploy? caGrid node Microarray data management system caArray Translational Genomics Core Facility PROGRESS project Clinical and microarray data integration (PROGRESS) caAdapter (CCHC) caXchange CTODS or (caIntegrator2) Data Sharing and Security Framework (DSSF) Complete set of agreements & contracts

14. Deploying caGrid Node Project Milestone for Year 1 Leverage role in ICTSA Advanced IT Core Provided hardware and expert installation help Installed caGrid node+caArray to meet milestone Exploring further collaborations caGrid node management – IUSCC core skill?

15. Deploying LSD Application (caArray) Project Milestone for Year 2 Two tracks: Production Infrastructure for TGCF (Illumina Core) PROGRESS project Manage Illumina SNP data Platform for data sharing Data Integration – caAdapter. caXchange, CTODS Serve as data integration platform for other projects

16. Prostate Cancer Genetic Risk Evaluation of SNPs (PROGRESS) Define high-risk genetic profile in metastatic prostate cancer through analysis of host genetic variants using Illumina system. Status Pilot data available ( 160 samples) Data integration and analysis performed traditional manner – SAS datasets Defining data extraction and integration procedures

17. PROGRESS Goals Use caArray to organize SNP data Extract clinical data from Oncore, standardize, and pipe into caBIG integration pipeline Post data on caGrid and allow secure data sharing with collaborators

18. Extracting Data from Oncore Collaborating with Percipenz to define Web Services API to export Subjects and Labs data Convert CSV, or XML file to HL7v3 using caAdapter (CCHC) Two paths forward: Internal – convert to SDTM and SAS data sets + data dictionary External – share as HL7v3 or load into CTODS Concerns about HIPPA – sign additional agreement

19. Short and Long Term Goals Organize SNP Data Integrate with Clinical Data Share Data with Collaborators Organize Translational Core Data Translational Medicine Multi Center Studies PROGRESS Goals Center Goals caArray Integration Pipeline caGrid

20. Data Sharing Milestone Year 2 Share PROGRESS data with collaborators Use DSSF as decision making tool Evaluate and provide feedback to DSIC Initial feedback about DSSF positive Challenges Legal community - IRB, HIPPA Compliance, Sponsored Research and Tech Transfer Meaningfully engage Legal staff for sustained effort Difference in perspective

21. caBIG ® Data Sharing and Security Framework

22. Data Sharing Share data depending on: Proprietary Value – Tech. Transfer Data privacy – HIPPA IRB or Institutional Restrictions Sponsor Restrictions Green, Yellow and Amber lanes Publication

23. Data Sharing Leverage role in ICTSA Involve IU Center for Bioethics Members used to dealing with ethical issues and incomplete frameworks Will provide feedback to DSIC PredictER project Presenting caBIG to them Oct. 6 th. Involve Advanced IT Core Implemented NIST 800 Formal review by Compliance Office

24. Year 1 Status All grant milestones met Initiated internal collaborations AITC Center of Bioethics caBIG incorporated into 3 new grant applications DOD Breast Cancer DOD Synergy Grant – Prostate Cancer Lance Armstrong Foundation – Adolescent and Young Adult Cancers

25. Continuing Challenges PROGRESS Collaborators’ caBIG readiness uncertain Define and implement integration pipeline DSSF Determine how to incorporate DSSF without adding to Legal staff workflow Data sharing culture change CareWeb

26. Acknowledgements IUSCC Dr. Stephen Williams – Director Dr. Noah Hahn - PI, PROGRESS project Dr. Sunil Badve – Director, TGCF Dr. Michael Kelley – ITRAC Ms. Mary Murray - ITRAC Div. of Biostatistics Dr. Susan Perkins – Core Director Advanced IT Core Dr. Bill Barnett - Director Dr. Anurag Shankar - Assoc. Director Center for Bioethics Dr. Eric Meslin – Director Mr. Jere Odell – Librarian IRB, Compliance Offices