SOPs
Who can use Advarra eSource + EDC?
The EDC system is free-for-use by any UK investigator in need of a 21 CFR Part 11 compliant electronic 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 also be used as a robust data management tool even if 21 CFR Part 11 compliance is not required.
Why choose Advarra eSource + EDC?
- Full traceability and audit capabilities for data created and modified within the system with corresponding user and timestamp.
- 21 CFR Part 11 compliant electronic signature for PI approval of subject visit and form data.
- Exportable data dictionary, calendar specifications, and subject casebooks.
- Exportable raw data in Excel or SAS format for analysis.
- Data Monitoring and Data Management review and signoff processes.
- Ability for data monitors and data managers to query subject data and report/review all stages of query resolution.
- Vendor managed infrastructure with guaranteed disaster recovery and backup plans.
- Vendor adherence to ISO 27001 and ISO 27701 certification standards for information security and privacy governance.
When should I request to use Advarra eSource + EDC?
Protocols that have received their initial IRB approval can be built in the EDC system. Earlier communications are encouraged in order to start the preliminary processes prior to IRB approval.
How do I request my protocol be built in Advarra eSource + EDC?
To request an Advarra eSource + EDC protocol build, please submit our EDC Protocol Request Form.
How do I request access to Advarra eSource + EDC?
To request Advarra eSource + EDC access, please submit our EDC User Access Request Form.
Contact us at AdvarraEDC.Support@uky.edu