Advarra EDC

Advarra Electronic Data Capture (EDC) is a 21 CFR Part 11 compliant EDC system that is available for UK researchers. In addition to a robust traceability of all data entered or modified within the EDC case report forms, Advarra EDC is integrated with Epic-Beaker to retrieve and post lab results automatically. The system will help streamline data collection/management, data monitoring/review, and incorporate an electronic signature approving all data collection instruments. This system will enhance overall data integrity and quality for investigator-initiated studies enterprise wide, especially those regulated by the FDA. 

This system is free-for-use by any UK investigator in need of a 21 CFR Part 11 compliant data capture system.  The primary audience are those investigators with an IIT that have a drug/device trial that will require electronic submission to the FDA. However, the system may be used as a robust data management tool even if Part 11 compliance is not required.

1. Full traceability and audit capabilities for all data created and modified within the system with user, date, and timestamp.
2. Part 11 compliant electronic signature for PI approval of Case Report Forms (CRFs).
3. Exportable data dictionary, calendar specifications, and subject casebooks.
4. Exportable raw data in SAS format for analysis.
5. Required User Acceptance Testing prior to live use of any subject forms.
6. Data Monitoring and Data Management signoffs.
7. Ability to query data and report and monitor all stages of form/query resolution.
8. Vendor supported and managed infrastructure with guaranteed disaster recovery and backup plans. 
9. Vendor managed infrastructure following ISO 27001:2013 information security framework for data security.

Protocols that have received their initial IRB approval can be built within the Advarra EDC system.  You are welcome to communicate and start the process prior to approval and we encourage early communications. Once a protocol receives IRB approval, the build process will officially begin.

To request an Advarra EDC build for a protocol, click here.