SemanticBits

There is a distinct lack of open source solutions for managing patient registrations onto clinical trials. Many cancer centers use paper based registrations in parallel with an ad hoc software solution, such as Excel spreadsheets or a MS Access database. This approach is extremely error prone and does not at all facilitate reporting, whether it be in-house accounting of the registration statuses of ongoing trials or reporting to federal agencies. Furthermore, a more sophisticated solution is needed to manage complex trials with multiple segments (e.g. screening, treatment, followup, etc.) and companion protocols.

The Cancer Central Clinical 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 easily integrated into your legacy systems and existing CTMS solution through open APIs, the use of standard technologies, and importing studies, subjects, and registrations directly into the system. Furthermore, C3PR can be integrated into ongoing multi-site clinical trials by posting data directly to coordinating centers and cooperative groups. This reduces double data entry and erroneous registrations.

C3PR is a highly modular software solution for managing registrations to clinical trials. It can easily be integrated into your existing clinical trials enterprise through out-of-the-box data loading features, open APIs, and a standardized relational database. C3PR allows you to model arbitrarily complex trials with multiple phases (e.g. screening, any number of treatment segments, followup, etc.), different types of randomization, and companion protocols. Furthermore, you can store eligibility answers directly in C3PR to help maintain accountability. C3PR produces the cancer center Summary 3 Report and can produce a variety of non-standard reports through the Advanced Search Interface. Finally, C3PR can be plugged into a multi-site setting by allowing your affiliates to login in an ASP model or by directly submitting study definitions and registration records through services.

We leverage Java/J2EE as the fundamental platform for developing C3PR into a scalable enterprise application. The design is inspired by the J2EE n-tier architecture. In the Web layer, we extensively use Spring MVC to manage user interactions with the application. AJAX is used widely across the application, including DWR, Scriptaculous, and eXtremeComponents. We leverage the Acegi Security Framework to provide authorization filters at each layer, which integrates well with local authentication and single sign-on. C3PR supports the Oracle and Postgres databases, the schemas of which are automatically ugraded when a new version of the application is deployed. We leverages the Drools rules engine for business level notifications and Quartz for scheduling them.

C3PR has been developed in collaboration with Duke Comprehensive Cancer Center, Wake Forest University, Mayo Clinic, Lombardi Comprehensive Cancer Center, Westat, CALGB, CCR, and the Coalition of Cooperative Groups. Our primary adopters include Duke and Wake Forest with engagement of Georgetown and CCR. C3PR is also being actively adopted throughout the cancer research community by sites such as the University of Arkansas for Medical Sciences (UAMS).

C3PR version 1 was released in 2006. Release 2 was developed by Duke Cancer Center in collaboration with SemanticBits, LLC and was released in March, 2008. Release 2.5 was made in March, 2009, and we are currently working C3PR 3.0, which is slated for late fall, 2009.

PreviousNext

The C3PR development team uses YourKit for performance profiling. YourKit is kindly supporting open source projects with its full-featured Java Profiler. YourKit, LLC is the creator of innovative and intelligent tools for profiling Java and .NET applications. Take a look at YourKit's leading software products:
YourKit Java Profiler and YourKit .NET Profiler.