C3PR

From CTMS_WIKI

Project Summary

The Cancer Center Participant Registry (C3PR) is a web-based application used for end-to-end registration of patients to clinical trials. This includes capturing the consent signed date, eligibility criteria, stratification, randomization, and screening. Clinical workflows are enabled by both subject- and study-centric views into the registration process. C3PR can be run in a standalone mode where study definitions, investigators, study personnel, and sites are entered into the system, or C3PR can be run in an integrated mode with the caBIG Clinical Trials Suite (CCTS). C3PR also enables multi-site clinical trials where registration information is entered locally at affiliate sites and the registration is completed by call-out to the coordinating site.

Throughout the development of C3PR, a number of elaborator and adopter sites are actively being engaged to help define requirements and test the application. Our primary elaborators include Duke, Wake Forest, Mayo, Westat, CALGB, CCR, and the Coalition of Cooperative Groups. Our primary adopters include Duke and Wake Forest with engagement of Georgetown and CCR.

C3PR release 1 was developed by Nortel Solutions and released in 2006. Release 2 was developed by Duke Cancer Center in collaboration with SemanticBits, LLC and was released in March, 2008. We are currently in the next phase of development with releases slated for the end of September, 2008 and March, 2009.

Vision Statement

The vision of the C3PR project is to extend the existing system and underlying database to enable additional capability for the capture and management of:

• Clinical trials participant registration.
• Protocol information.
• Clinical trials registration information across different clinical studies.
• Information on referring physicians, research sites, and organizations.
• Timely access to information for clinical research staff and physicians.

Current functionality includes:

• Management of Registrations, Subjects, Studies, Investigators, Personnel, and Organizations.
• Registration of Subject to Studies, including capturing consent signed date, eligibility, stratification, and randomization.
• Study Amendment.
• System integration through CCTS, APIs, and XML upload/download.
• Secure access to functionality, including authentication, role-based authorization, and grid-based.
• Logging and Auditing through database and application container functionality.
• Exception handling.
• Multi-site support for study definition and registration.

Latest Documentation

C3PR Team

C3PR is a highly collaborative project made up of domain and technical experts from Duke Cancer Center, SemanticBits, Wake Forest Cancer Center, Mayo Clinic, CALGB, and Westat.

Installation

C3PR can be installed through a graphical wizard-like installer. It requires some software be installed, such as Java and Ant. See our Installation Guide and Initial Configuration Guide for more information.

You can also check out our fully functional demonstration site. The Login is: c3pr_admin. The Password is: c3pr_admin. We recommend that you look over the End User Guide and/or Use Cases as you walk through the demonstration site.

Alternatively, you can checkout and build C3PR from source:

• Subversion repository: https://gforge.nci.nih.gov/svnroot/c3prv2
• Subversion module: codebase
• User name: anonymous
• Password: anonymous
• Prerequisites: Java 1.5, Ant

See our Build Instructions for more information.

Project Planning

We engage in Agile project development, where we focus on time-boxed iterations that result in a deployable, testable application at the end of each iteration. As part of the iterative development, we actively engage with stakeholders on a regular basis. This section describes our project plan and meeting schedule.

Project Management

In line with our Agile development methodology, we have adopted a modified version of Scrum. Checkout our Scrum Artifacts for a Product Backlog of prioritized features and our latest and past Sprint Backlogs.

For additional information, please view our Project Plan and Communications Plan.

See our Adoption Plan for more information on how we plan to adopt C3PR into the adopter sites.

Meetings

All-hands Calls

In a project as highly collaborative as C3PR, frequent and open communication amongst all stakeholders is critical to success. In line with this, we have weekly All-hands calls that are mandatory for funded adopters and elaborators but open to anyone.

Teleconference Information

• When: every Monday 13:00-14:00 EST
• Phone: 866-795-7022
• Passcode: 9475239
• Web: http://ncicb.centra.com
• Meeting ID: C3PR Project

Agendas and Meeting Notes

See our agenda and meeting notes template.

Face-to-face Meetings

We hold a number of closed face-to-face meetings for team building, planning, and hashing out use cases. These include:

• 2008 Kickoff

Daily Scrums

In alignment with Scrum methodology, we hold daily Scrum meetings that last no more than 15 minutes. Each member of the technical team describes:

• What they worked on yesterday
• What they plan to work on today
• Any obstacles that are facing or foresee

Teleconference Information

• When: daily 10:00-10:15 EST
• Phone: 1-866-733-9588
• Passcode: 6526905

Project Collaboration

C3PR is a highly collaborative project involving stakeholders from our funded adopter and elaborator community, caBIG, NCI, and the larger cancer research community. In order to uphold the caBIG philosophy of open development, we engage in collaborative development of use cases and requirements through this wiki. The following sections are used to interactively develop use cases and requirements, as well as keep all stakeholders abreast of current development.

Bleeding Edge Use Cases

Use cases we are currently working on:

• C3PR Summary Report Approach
• C3PR Enterprise Services Approach
• C3PR COPPA Integration Approach

Previous Documentation

C3PR 2.5.5

Templates

• Template:C3PR Summary
• Template:C3PR Documentation
• Template:C3PR Documentation 2.5.5
• Template:C3PR Team
• Template:C3PR Vision Statement
• Template:C3PR Roles
• Template:C3PR Roles 2.5.5
• Template:C3PR Roles Old
• Template:C3PR Glossary
• Template:C3PR References
• Template:C3PR caBIG License
• Template:C3PR caBIG License 2008