# Presentation: 577528

## Cancer Clinical Trial Suite (CCTS): An Introduction for UsersA Tool Demonstration from caBIGTM 

**	****	****                 ****Bill Dyer**
**(NCI/Pyramed Research)**
**	****            **
**June 2008**

## caBIGTM Overview

**caBIGTM Overview**

**	**
**	**caBIGTM 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.
**	****caBIGTM 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

## Agenda and Goals

**or set up your tools with caBIGTM 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*

*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*

**CCTS Applications**

**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

## caXchange Hub

*Tracks the patient schedule **throughout the study*

*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

## 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

- Clinical Trial Object Database System

**(CTODS)**

- Format A

- _[https://cabig.nci.nih.gov/tools/LabIntegrationHub](https://cabig.nci.nih.gov/tools/LabIntegrationHub)_

- Laboratory Information System

## CCTS Demonstration

## Key Demonstration Activities

**Add and Register a Subject**
**Broadcast the Subject Registration Information to the other CCTS Applications**
**Review the Patient’s Calendar**
**View the Patient’s Labs and Transfer the Appropriate Labs to C3D**
**Enter AE in caAERS, Submit Expedited MedWatch and Alert PSC**
**View the AE Alert in PSC, and Change the Patient’s Calendar Due to the AE**
**Review and enter CRFs**

## Demonstration Workflow (1-2)

## Demonstration Workflow (3)

**Demonstration Workflow (3)**

## Demonstration Workflow (4)

**Demonstration Workflow (4)**

## Demonstration Workflow (5)

**Demonstration Workflow (5)**

## Demonstration Workflow (6)

## Demonstration Workflow (7)

**Demonstration Workflow (7)**

## CCTS Demonstration

## Other Key Features of the CCTS

**Single Sign On (SSO)**
**caGrid and the Common Security Model (CSM)**
**Auditing features**
**Logging**
**Enterprise Services Bus (ESB)**
**Support for multiple databases and web browsers**

## Two Pathways: Adopt or Adapt

- Interested organizations are **not required to adopt** caBIGTM applications to connect with caBIGTM
- There are other ways to share data and use common data elements and controlled vocabularies by **adapting** current or non-caBIGTM 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=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  |

## 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.gov](mailto:caBIGconnect@cancer.gov)**_** **