AEFI

Dacima's Adverse Event Following Immunization (AEFI) is a web-based vaccine safety surveillance application designed for post-marketing safety surveillance. It collects, manages, and analyzes information about adverse events — possible side effects — that may occur following vaccine administration. The module is compliant with 21 CFR Part 11 and Health Canada requirements.

The platform provides standard data entry screens for adverse event collection, with options to customize forms to meet specific organizational needs. It supports automatic MedDRA coding and includes a link to the Brighton Collaboration (ABC) tool, allowing users to confirm an AEFI diagnosis directly within the software.

Core Features

• Standard pre-configured adverse event forms
• Medical coding with support for automatic MedDRA coding
• Diagnostic confirmation tool via Brighton Collaboration (ABC) integration
• Real-time data validation, conditional skip patterns, and validation checks
• Automatic email notifications
• Dashboards, standard reports, and custom reporting options

Data Management and Compliance Capabilities

• Adverse event status tracking and management features
• Electronic signatures
• Built-in data clarification forms and reports
• Complete audit trail
• SAS and SPSS code generator
• Data extraction features and options

Dacima AEFI is offered as a web platform and is developed by Dacima Software Inc., part of the EvidentIQ Group. A fully functional trial version is available, and personalized demos can be arranged to assess fit with specific study requirements.