SemanticBits

The timely and appropriate reporting of adverse events is critical to maintaining and improving the safety of therapeutic interventions. The specific reports required for each adverse event is determined by many factors including the severity, expectedness, and potential causation of the event, along with rules governed by regulatory agencies, trial sponsors, clinical trial protocols, and institutional review boards. In addition to the complexity of reporting requirements, the systems used to report adverse events are often isolated from the systems used to record adverse events, resulting in duplicative data entry.

The Cancer Adverse Event Reporting System (caAERS) is a highly configurable, standards-based, web application for documenting, reporting, and analyzing adverse events. Key features of this system include:

• Single entry for all adverse events including serious, non-serious, and solicited adverse events.
• A powerful, state-of-the-art rules engine providing automated assessment and reporting of adverse events in compliance with regulatory and protocol requirements.  
• Electronic expedited adverse event report submission to the NCI Cancer Therapy Evaluation Program (CTEP) AdEERS system.
• A easy-to-use report builder, which allows authoring and customization of adverse event reports using NCI and FDA compliant report templates.
• A powerful work-flow management feature, which facilitates routing adverse event reports to the appropriate personnel for review, comment, and approval prior to submission
• Robust user and programmatic interfaces for import and export of of adverse events, protocol, participant, research staff, and investigator information.
• Several programmatic interfaces that support robust integration with multiple external systems and data sources.
• An advanced email-based notification system that sends customized alerts and reminders to recipients at configurable delivery times.
• Support for multiple vocabularies and coding systems (e.g. CTCAE and MedDRA)
• Web 2.0 style user interface

Some of the key benefits that this system offers are:

• Increase compliance with regulatory, sponsor, and protocol adverse event reporting requirements.
• Eliminates reconciliation of adverse event data between expedited reports and study data.
• Reduces data entry due to reuse of data between reports for the same subject and through integration with other systems and data sources.

We heavily leverage industry standard open source technologies in the development of caAERS. Some of the key technologies include: Spring Framework, JBoss Hibernate, JBoss Drools, JBoss jBPM, Quartz, XFire, Apache Formatting Objects Processor (FOP), Prototype, Scriptaculous, Direct Web Remoting (DWR), Apache ServiceMix, Apache Ant, Ivy, Hudson, Yahoo User Interface Library (YUI), PostgreSQL, and Oracle.

caAERS is the product of a collaboration with the global cancer research community, and supports clinical trial business processes ranging from small scale, single site, stand-alone operations to large scale, multi-site, integrated enterprises. caAERS is currently being actively implemented by several organizations worldwide. Some of these organizations include: The Mayo Clinic Center, Wake Forest University Comprehensive Cancer Center, The Cancer and Leukemia Group B (CALGB), and Roswell Park Cancer Institute. Additionally, caAERS is being actively piloted by the NCI Cancer Therapy Evaluation Program (CTEP).

The first production release of caAERS (version 1.0) was released March 2008. caAERS version 1.9 was released in April 2009 and the system is actively enhanced with production releases occurring every quarter.

Next

The caAERS 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.