The Cancer Adverse Event Reporting System (caAERS)

The Cancer Adverse Event Reporting System (caAERS) is used to collect, process, and report adverse events that occur during clinical trials. The tool supports regulatory and protocol compliance for adverse event report and allows local collection, management, and querying of adverse event data, whether routine or serious. This tool also supports service based integration of data from other clinical trials management systems.

FEATURES:

• Adverse event (AE) tracking and classification using accepted standards (e.g. CTC 2.0/3.0 and MedDRA)
• The ability to import information regarding protocols, participants, research staff, and investigators using a user interface or exposed services.
• The ability to export of adverse event data in common or required formats
• Automated, rules-based assessment of seriousness and reporting requirements using sponsor-level, institution-level and protocol-level rules
• Ability to submit electronically to the Adverse Event Expedited Reporting System (AdEERS) of the NCI Cancer Therapy Evaluation Program (CTEP)
• Maps to vocabularies and coding systems
• Generates customizable reports and submits to external agencies, including generation of NCI
• Capable of capturing all AEs, including serious, routine, and solicited adverse events.

Visit : http://www.healthcit.com/front/caBIG/node/68