Advarra EDC

This is an Electric Data Capture (EDC) system that is that is compliant with 21 CFR Part 11 and used primarily in with Cancer Research Clinical Trials. The application is an eSource option for Clinical Trials eliminating paper entry by providing real time remote data entry. The platform features user-friendly, quality-assured data capture workflows and robust remote monitoring tools, facilitating seamless collaboration between sites and sponsors.

Access  is role based and is segmented into two major Org Units — Cancer Center and General Research, with additional fields and features available for Cancer Clinical Trials. Each Staff member that will be working in Advarra EDC will need permission from the data management team per protocol. Once approved RCTA will enroll the user in training to understand the  application. Once completed and passed the user will be provided access.

• Advarra EDC is  compliant with 21 CFR Part 11 protections.
• Primary use for investigator-initiated trials (IITs) for quick data submission replacing the need for paper entry
• Quick fit-for-purpose replacement of EMR data collection
• Quick training and integration with partner institutions
• Remote oversight for data management to review incoming data
• Send accurate, valid documentation to the FDA
• Have necessary audit trails

Advarra EDCs is hosted by Advarra and managed entirely by RCTA.

To learn more, please reach out to researchedc@uvahealth.org