Health sciences studies requiring 21 CFR Part 11 compliance have a new option for capturing study data, with the availability of Advarra electronic data capture (EDC) at the University of Minnesota and M Health Fairview.
CTSI purchased and is dedicating staff toward the electronic data capture tool to give researchers an easy, compliant way to manage, monitor, and sign off on clinical trial data. Advarra EDC is ideal for investigator-initiated, FDA-regulated studies or researchers who want greater integration with the OnCore clinical trial management system (CTMS).
Compliance for FDA-regulated studies
Advarra EDC is a 21 CFR Part 11 validated system, ensuring data security and integrity with audit trails and secure signatures. 21 CFR Part 11 compliance applies to all FDA-regulated studies (IND, IDE, NSR-IDE).
University of Minnesota researchers can continue to use REDCap and OnCore’s electronic Case Report Forms (eCRFs) to store data, but neither system is Part 11 compliant. REDCap and OnCore’s eCRFs require users to keep source documents (paper documents, EPIC, etc.), ensure the source data is signed/initialed, and notate when they manually enter the data into OnCore. There is no need to do this with Advarra EDC.
Advarra EDC’s integration with the OnCore clinical trial management system (CTMS) minimizes duplicate data entry, while maintaining consistent information across systems. This integration allows users to streamline data management with regard to:
- Organizations: Pull all organization records from the organization administrator into Advarra EDC.
- Protocols: Import a protocol from OnCore and create a link between OnCore and Advarra EDC.
- Subjects: Subjects in OnCore can be automatically created in Advarra EDC.
Advarra EDC’s intuitive interface and robust form capabilities further saves time. Multiple form layout options with drag-and-drop functionality eases form-building, plus users have the ability to create a library of forms and edit checks for re-use on multiple protocols.
For questions or to start using Advarra EDC for your study, contact CTSI’s Advarra EDC team at [email protected].