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

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

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

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

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

Introduction to caXchange

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

caXchange Functionality Fits into the Cancer Clinical Trials Suite (CCTS) 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

CCTS Demonstration

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

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

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

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

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

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

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

CCTS Demonstration

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

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

Online Resources

CCTS Online Resources Clinical Trials Management Systems (CTMS) Workspace &sid=ctmsws&status=True Tool Landing Page Access to CTMS Tools: Recorded Demos Presentations Documentation and Training Materials Live Demo Environment &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 NCI Center for Bioinformatics Application Support

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