# Presentation: 922517

##  C3PR: An Introduction for UsersA Tool Demonstration from caBIGTM 

**	****	****                 ****Vijaya Chadaram**
** ****Duke Cancer Center**
**	****	****            ****April 29, 2008**

**Notes:**
“Hi! I’m Vijaya chadaram, clinical trials manager from Duke comprehensive cancer center, within caBIG, I’m subject matter expert or domain expert translates to end user 
How many end users in the audience?. What tools are used currently?
The purpose of this demo is to provide high level overview of functionality of C3PR for end users (target audience), not too technical and also to gather your input on if this tool provides any benefit, user friendly etc. and proposed enhancements. 

## Agenda and Goal

**or set up your tool to interface with this one.**

**Agenda and Goal**

**Overview and Introduction to C3PR**
**Demonstration of user functionalities**
**Resources and Next Steps **

**Notes:**
“Today, we will open with a brief overview of the goals of caBIG, to set the stage for the rest of the presentation.  Then, we will turn quickly to introducing C3PR and reviewing its functionality.  
“The goal of this demo is to show you a caBIGTM tool that is available for adoption.  I want to emphasize though, that you have many options, and that you are not restricted to adopting a caBIGTM tool.  You can also adapt your existing tool to become caBIGTM compatible, or set up your tool to interface with this one.  If the tool we show you today isn’t right for you, we’ll point you to the right places to learn about alternative paths.”  

## 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

**Notes:**
“For those new to caBIG, here is a quick view of what the overarching caBIG mission and vision is.  When you connect with caBIG, you aren’t just using a tool, you are connecting with a larger community striving to accelerate discovery in cancer research.  We want to connect people through a shared infrastructure, make it easier to share information where appropriate, and provide tools that support a life cycle of research and care.”  

## Introduction to Cancer Central Clinical Participant Registry (C3PR) 

**Notes:**
“Now, let’s turn to the tool we are looking at today: C3PR. 

## Introduction

**C3PR Release 1**
- Developed by Nortel Solutions
- Baseline functionality for registering patients to pre-defined protocols
- Released for testing in 2004, production in 2006
-  **C3PR Release 2**
- Developed by Duke Comprehensive Cancer Center
- Extends the Release 1 functionality
- Project began in November 2006, production in 2008
**C3PR Release 3**
- Developed by Duke Comprehensive Cancer Center
- Builds upon the functionality in release 2
- Project began March 2008

**Notes:**
C3PR release 1 was at NIC cancer research center
C3PR release 2 at Duke and WFU
C3PR release 3 in development

## How C3PR fits into the Research Continuum

**How C3PR fits into the ****Research Continuum**

**Clinical Research**

**Pathology**

**Molecular Biology**

**Imaging**

- C3PR is a web-based application used to manage participants in cancer clinical trials.

**Notes:**
C3PR is one in a set of complementary tools called the caBIGTM Clinical Trials Suite (CCTS).  Like all of the caBIGTM tools, C3PR plays a specific role in the cancer research continuum – which can be loosely grouped into four categories, Clinical Research, Imaging, Pathology, and Molecular Biology.”  

C3PR is designed to standardize and automate subject registration process in cancer clinical trials.

## Where does a participant registry fit in?

*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 v2)**

**Patient Study Calendar (PSC)**

**Clinical Trial Data**
**Management Systems (C3D)**

**Cancer Adverse Event**
**Reporting System (caAERS)**

*Identifies adverse events*
*and any associated*
*schedule changes*

**Notes:**
After consenting the subject Participant registry or registering a subject to the clinical trial is the first step in connecting subject to a clinical trial. 

## Using C3PR Who and Why? 

**Target Users:**
- Registrars that register subjects to studies
- Study Coordinators that monitor study activity and update the study definition
- Site Coordinators that assign studies to Study Coordinators
- Administrators that administer clinical systems
**Core Functions / Modules**
- Participant Management
- Study Management
- Registration Management
- Reporting
- Integration

**Notes:**
(Note:  The previous slides were primarily big picture about how the tool fits within the landscape – now, we are getting into more concrete information about this specific tool – who would use it, and what is does.  In this slide, be specific about the types of users that would use the tool, and a thumbnail sketch about what it actually does.  How does the tool fit within a typical users’ workflow? What is the work setting in which tool use would occur?  After and before, or in support of, what activities?)

## More on How C3PR Benefits Your Research

**Participant Management**
*Investigators, study personnel, treating physician, subjects*
**Study Management**
*Study structure, diseases, notifications, blinded studies*
**Registration Management **
*Consent, eligibility, stratification, randomization, enrollment*
**Reporting**
*Registrations, protocols*
**Integration**
*Exchange study definition and registrations with multi-site C3PR and CCTS*

**Notes:**
Participant Management: This component will manage all aspects of the participant data including address, contact information, searching, synchronization with external systems and relations management. 

Protocol Management: C3PR Release 2 will allow for searching of protocols, registration history. C3PR does not aim to be the primary protocol management system, however it contains basic Protocol information. 

Registration Management: Complete registration management will be provided within the C3PR system including stratification, assignment to protocol arms with and without randomization. The Release 2 system will also provide for integration of registration status information with the Lab Hub, Patient Study Calendar and other CTMS systems. 

Eligibility Criteria Management: The new C3PR system will continue to support the optional import, review and approval process of the eligibility criteria. this support will include distinct eligibility checklists for different phases (or epochs) of the same protocol. 

Clinical Data Access: C3PR will provide direct access to clinical data in C3D (and other clinical data management systems) for the selected patient on the selected protocol. 

## More on How C3PR Benefits Your Research

**Integrate**** with other clinical systems**
**caBIG Clinical Trials Suite**
- Patient Study Calendar (PSC)
- Cancer Adverse Events Reporting System (caAERS)
- Cancer Clinical Database (C3D)
- LabViewer/CTODS
**Multi-site Trials**
- Coordinating site exchanges study definition
- Affiliate sites exchange registration information
- Coordinating site randomizes and enrolls subjects

## Demonstration of C3PR

**Notes:**
“Now, let’s take a closer look at the tool itself. “

## Key Functions for Demo

**Adopters of C3PR**
**Duke University**
**Wake Forest University**

**Review a Study**
**Add a Subject**
**Register a Subject**
**Manage a Registration**
**Review other functions**

**Notes:**
Speaker: On this slide, quickly preview the workflow elements that you are going to present, focusing on why a user would be interested – e.g., the scientific problem or need it addresses.   Make sure that the demo that follows clearly maps to this preview, so that people can see the link between the demonstration and the workflow element it addresses. 

## C3PR Navigation Bar

## A Quick Review:  Key Functions and Benefits of C3PR 

**Participant Management**
*	**Investigators, study personnel, treating physician, subjects *
**Study Management**
*	**Study structure, diseases, notifications, blinded studies*
**Registration Management **
*	**Consent, eligibility, stratification, randomization, enrollment*
**Reporting**
*	**Registrations, studies*
**Integration**
**	***Exchange study definition and registrations with multi-Key Functionality *

**Clarifying Tool Boundaries.  **No tool meets all user expectations.  Here are some functions that are *outside* the scope of this tool.
- Managing the history of study definitions
- Managing the activities associated with subjects on studies (e.g. calendar)
- Managing clinical data

**Notes:**
“Here’s a summary of the tool’s key functions and benefits we just reviewed. .  We also want to clear on what the tool does not do that you might get questions about.  Here are some tool boundaries, to help you have an honest discussion with potential users in your organization about whether this tool is right for them. caBIG has an active development community, so if you have a specific need that the tool does not currently fill, there are forums for raising your concern to those guiding future development efforts.  With the right internal or contract staff, you could even extend the tool to meet those specific needs on your own.” 

## Getting Started: A Glance at the Technology

**Tool Platform: **web application hosted by an institution or NCI – requires a web browser for end user access
**Key Prerequisites: **database (Oracle or Postgres), application container (Tomcat), Java
**End User Readiness:  **administrators installing C3PR will require familiarity with databases and web applications; users of C3PR will require basic clinical knowledge and several hours of training/orientation

**Notes:**
(This is a BRIEF technology lay of the land, just so people understand how this works, and the possible investment/ learning curve needed to get going.) KEEP IT FOCUSED ON WHAT THE TYPICAL USER NEEDS TO KNOW OMLY!! 

## Resources and Next Steps

**Notes:**
“Let’s take a look at the next steps and resources that can help you get started on the path to adopting (tool name).” 

## Two Pathways: Adopt or Adapt

- Interested organizations are **not required to adopt** this caBIGTM application 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

**Notes:**
“As we said at the start of this presentation, adopting this tool is one way to connect with caBIG.  You also have the option of adapting your own tool to be compatible with caBIG standards and infrastructure.  This presentation has been about adopting this specific tool – other presentations available from caBIG can tell you more about the adapt path.”  

## Adopting C3PR Release Timeline and Future Plans

**Release Information**Current Version Number:  2.0
- Release Date: March 2008
- caGrid Enabled
**Development Schedule**
- Release 2.5 in September, 2008 and release 3.0 in March, 2009
- Planned enhancements include companion protocols; further integration with CCTS, OPEN, and RSS; enhanced reporting such as Summary 3/4; customization to fields and diseases; hosted mode; etc.
- Development is active with requirements gathering from adopters (Duke, Wake), elaborators (Mayo, CALGB, Westat), caBIG, and the cancer research community
**Support Available**
- _[ncicb@pop.nci.nih.gov](mailto:ncicb@pop.nci.nih.gov)_

**Notes:**
“If this tool looks right for you, here’s some information about the current release and future development plans.  There’s also some information about the support that’s available if you are seeking an external resource for help.  caBIG is continuing to grow, so it’s expected that additional support resources will become available as we proceed – there’s information about the caBIG Enterprise Support Network on the caBIG community website that will ell you more about these options.”

## Resources for C3PR

| C3PR Online | https://cabig.nci.nih.gov/tools/c3pr |
| --- | --- |
| Tool Landing Page | https://cabig.nci.nih.gov/tools/c3pr |
| Access to Demo Passwords and 
Logins | URL: https://sbdev1000.semanticbits.com:8021/c3pr-demo/public/login
User: c3pr_admin 
Password: c3pr_admin |
| Software Development
Project Site | http://gforge.nci.nih.gov/plugins/scmcvs/cvsweb.php/c3prv2/?cvsroot=c3prv2#dirlist |
| (Insert LISTSERV Name)
LISTSERV Signup | See Gforge above |
| Contact | Pankaj Agarwal: p.agarwal@duke.edu |
| NCI Center for
Bioinformatics
Applications Support | ncicb@pop.nci.noh.gov  |

**Notes:**
“Here are some critical URL’s and e-mail addresses to get you started – the Tool Landing page is where the most recent release and documentation and training for the tool is kept, so it’s a great starting place.” 

## 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)**_** **

**Notes:**
“Thanks for listening to this presentation – we’d like your feedback!  Here are some questions to get you started – send us a quick note at the e-mail below so we can continue to develop new materials that will support your needs.  I’ve enjoyed talking with you – and wish you all the best as you connect with caBIG!”