1. Cancer Clinical Trial Suite (CCTS): An Introduction for Users A Tool Demonstration from caBIG™ Bill Dyer (NCI/Pyramed Research) June 2008

2. caBIG™ Overview caBIG™ is an information network enabling all constituencies in the cancer community – researchers, clinicians, patients – to share data and knowledge to accelerate the discovery of new diagnostics and therapeutics, and improve patient outcomes. caBIG™ Vision Connect the cancer research community through a shareable, interoperable infrastructure Deploy and extend standard rules and a common language to more easily share information Build or adapt tools for collecting, analyzing, integrating and disseminating information associated with cancer research and care

3. The goal of this demo is to introduce you to the capabilities and benefits of the CCTS that are available for adoption from caBIG™. You can also adapt your existing clinical trial tools to become caBIG™ compatible or set up your tools with caBIG™ tools. Agenda and Goals Overview and Introduction to CCTS Introduction to the caXchange Hub Demonstration of Data Flow between CCTS Applications Resources and Next Steps

4. CCTS Applications Tracks the patient schedule throughout the study Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System

5. Tracks the patient schedule throughout the study Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured caXchange Hub Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System

6. Introduction to caXchange

7. Clinical Data Exchange (caXchange) is used to used to exchange clinical information between applications and systems Responsible for: Accepting or rejecting messages Transforming clinical data messages from one format into another Routing messages to other clinical systems caXchange is ‘middleware’ It lives in the ‘middle’ of CCTS It is invisible to most users

8. caXchange Functionality Fits into the Cancer Clinical Trials Suite (CCTS) https://cabig.nci.nih.gov/tools/LabIntegrationHub C3PR Cancer Central Clinical Participant Registry PSC Patient Study Calendar Lab Viewer caAERS Cancer Adverse Event Reporting System Central Clinical Data Management System Format B Format C caXchange Hub caXchange Hub Clinical Trial Object Database System (CTODS) Format A LIMS Laboratory Information System

9. CCTS Demonstration

10. Key Demonstration Activities 1.Add and Register a Subject 2.Broadcast the Subject Registration Information to the other CCTS Applications 3.Review the Patient’s Calendar 4.View the Patient’s Labs and Transfer the Appropriate Labs to C3D 5.Enter AE in caAERS, Submit Expedited MedWatch and Alert PSC 6.View the AE Alert in PSC, and Change the Patient’s Calendar Due to the AE 7.Review and enter CRFs

11. Demonstration Workflow (1-2) Tracks the patient schedule throughout the study Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System

12. Demonstration Workflow (3) Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Trial Data Management Systems (C3D) Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System Tracks the patient schedule throughout the study

13. Demonstration Workflow (4) Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System Tracks the patient schedule throughout the study Clinical Data Management System

14. Demonstration Workflow (5) Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System Tracks the patient schedule throughout the study

15. Demonstration Workflow (6) Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System Tracks the patient schedule throughout the study

16. Demonstration Workflow (7) Patient visits the Physician Eligibility is verified and patient is registered to a study Lab Viewer Identifies labs, loads them into the CDMS and AE system Clinical data is captured Cancer Central Clinical Participant Registry (C3PR) Patient Study Calendar (PSC) Clinical Data Management System Cancer Adverse Event Reporting System (caAERS) Identifies and tracks adverse events and any associated schedule changes caXchange (Hub) (CTODS) Clinical Trial Object Database System Tracks the patient schedule throughout the study

17. CCTS Demonstration

18. Other Key Features of the CCTS 1.Single Sign On (SSO) 2.caGrid and the Common Security Model (CSM) 3.Auditing features 4.Logging 5.Enterprise Services Bus (ESB) 6.Support for multiple databases and web browsers

19. Two Pathways: Adopt or Adapt Interested organizations are not required to adopt caBIG™ applications to connect with caBIG™ There are other ways to share data and use common data elements and controlled vocabularies by adapting current or non-caBIG™ applications

20. Online Resources

21. CCTS Online Resources Clinical Trials Management Systems (CTMS) Workspace https://cabig.nci.nih.gov/workspaces/CTMS/?pid=primary. 2006-10-24.9768040952&sid=ctmsws&status=True Tool Landing Page https://cabig.nci.nih.gov/tools/ Access to CTMS Tools: Recorded Demos Presentations Documentation and Training Materials Live Demo Environment https://cabig.nci.nih.gov/workspaces/CTMS/?pid=primary. 2006-10-24.9768040952&sid=ctmsws&status=True Product shortcuts for each tool provide access to: Recorded Demos Presentations Documentation and Training Materials Live Demo Environment NCI Center for Bioinformatics (NCICB) Open Source Project Site http://gforge.nci.nih.gov/ NCI Center for Bioinformatics Application Support ncicb@pop.nci.nih.gov

22. Thanks for Attending! We’d like to know what you think! Did you get useful information from this presentation? What additional information or future presentation topics would you like to see? Send your feedback to caBIGconnect@cancer.govcaBIGconnect@cancer.gov