cancer clinical trial suite (ccts): an introduction for users a tool demonstration from cabig™...
TRANSCRIPT
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 verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule changes
caXchange(Hub)
(CTODS)
Clinical Trial Object Database
System
Tracks the patient schedule throughout the study
Patient visits the Physician
Eligibility is verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
caXchange Hub
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule changes
caXchange(Hub)
(CTODS)
Clinical Trial Object Database
System
Introduction to caXchange
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)
https://cabig.nci.nih.gov/tools/LabIntegrationHub
C3PRCancer Central
Clinical Participant Registry
PSCPatient Study
Calendar
Lab Viewer
caAERSCancer Adverse Event Reporting
System
Central Clinical Data Management
System
Format B
Format CcaXchange
HubcaXchange
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 verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule changes
caXchange(Hub)
(CTODS)
Clinical Trial Object Database
System
Demonstration Workflow (3)
Patient visits the Physician
Eligibility is verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical Trial DataManagement Systems (C3D)
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule 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 verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule changes
caXchange(Hub)
(CTODS)
Clinical Trial Object Database
System
Tracks the patient schedule throughout the study
Clinical DataManagement System
Demonstration Workflow (5)
Patient visits the Physician
Eligibility is verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule 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 verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule 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 verifiedand patient is registered to a study
Lab Viewer
Identifies labs, loadsthem into the CDMSand AE system
Clinical data is captured
Cancer Central ClinicalParticipant Registry (C3PR)
Patient Study Calendar(PSC)
Clinical DataManagement System
Cancer Adverse EventReporting System (caAERS)
Identifies and tracks adverseevents and any associatedschedule 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
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=TrueProduct 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 forBioinformaticsApplication Support
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 [email protected]