Application Description

The Cancer Adverse Event Reporting System (caAERS) is an open source, standards-based, web application for documenting, managing, reporting, and analyzing adverse events (AEs). The system operates as both a repository for capturing and tracking routine and serious AEs and as a tool for preparing and submitting expedited AE reports to regulatory agencies.

Currently, caAERS works with cancer prevention and therapeutic trials and can accommodate a range of intervention types, including investigational and commercial agents, radiation, surgery, and medical devices. Adverse events can be coded in caAERS using either CTCAE or MedDRA.

To help organizations stay in compliance with AE reporting regulations, the caAERS application comes loaded with a full complement of industry-standard AE reports, including the FDA MedWatch 3500A form, the CTEP AdEERS reports, the NCI-DCP SAE form, and CIOMS. In addition, the caAERS system features a powerful, state-of-the-art rules engine, which can capture a range of sponsor, institution, and protocol-level reporting requirements.

Using these rules, caAERS can automatically determine if an adverse event requires expedited reporting and when and to whom the report must be submitted -- for any of an organization's trials. The business rules used by caAERS can be authored within the application itself or imported from a library of approved rule sets. caAERS also features an advanced email-based alert system that can be customized along a number of dimensions (message content, recipients, delivery times) to ensure that notifications and reminders are sent out as needed. Also included as part of caAERS is an easy-to-use report template generator, which allows users to build and customize reports.

caAERS can be deployed as a stand-alone application or as an integrated module within the caBIG Clinical Trials Suite (CCTS).

The caAERS application has completed development and is currently in the transition phase. The target public launch date for caAERS 1.0, as a stand-alone application, is March 3, 2008. caAERS is HIPAA, 21 CFR Part 11, and Section 508 compliant.

Project Description

Client: NCI

The initial performance period is approximately 12 months and is divided into three phases: Elaboration, Construction, and Transition. SemanticBits is the lead on the project. Our development partners include Northwestern University and Akaza Research. The funded caBIG Adopters are the Mayo Clinic and Wake Forest University.

The following modules were implemented in caAERS v 1.0:

• Adverse Event (AE) data capture
• Interface Between AE Capture Tool & Local Clinical Trials Databases
• Vocabulary Mapping Service
• External Agency Reporting

In developing caAERS, the SemanticBits team is leveraging well proven open source frameworks such as Spring, Hibernate, JBoss Drools and Scriptaculous and integrating existing caBIG components as a fundamental part of the model-driven architecture to achieve caBIG Silver compatibility and to position for later deployment on caGrid (Gold-level compliance). We have practiced domain driven design and framework based approaches in the implementation of caAERS.

In October 2007, SemanticBits was awarded an extension of the contract to develop additional features, including caAERS to AdEERS integration, import of routine AEs, and CCTS 1.0 interoperability.