CRConnect, Florence eBinders, OnCore

CRConnect: Clinical Research Connect is a hub to help you get organized for study start-up, with instructions and steps of what’s needed, and which systems are involved. CRConnect provides opportunities to collaborate within the study team, where everyone will know where steps are and have access to the most updated information. This system also provides single data entry and a more streamlined process for many study start-up components. The goals of implementing CRConnect across the School of Medicine are:

The ability to capture study start-up data electronically
Centralized, electronic submission & approval processes
Auto-generation of documents and forms
Automation of email notifications and process status
Integrated electronic document signature approval process
Clear visibility as to:
- What compliance requirements and approvals the study requires and the approval status of each
- The status of HSR/IRB Submission
- The status of HSR/IRB Approval
- The study “Open for Enrollment” status

For support: CRConnectSupport@uvahealth.org or 434.297.5757, Option 2

https://www.medicalcenter.virginia.edu/intranet/cto/crconnect-uva-help-page-2

Florence eBinders: An electronic regulatory system that is used for clinical research studies conducted within the UVA School of Medicine. Florence eBinders is designed to replace physical binders and paper forms, giving clinical research teams an efficient and compliant way to electronically sign, manage, store, and collaborate on study documents. Features include:

Remote data access – Access study binders and files from anywhere in a secure, user-friendly way.
Electronic signatures – Study teams no longer need to physically transport paper documents from person to person or utilize DocuSign. Signatures in eBinders are 21 CFR Part 11 compliant.
Remote monitoring – Monitors are given access to the files they need, signed subject consents, protocol consents, and most importantly – documents which contain PHI.
Streamlined document updating – Upload documents once and file them in multiple study binders.
OnCore integration – The OnCore team will facilitate the creation of a “shell” protocol to sync with eBinders, making it easier to begin uploading protocol regulatory documentation at protocol start-up

For support: Florencesupport@uvahealth.org or 434.297.5757 option 3

https://www.medicalcenter.virginia.edu/intranet/cto/florence-ebinders

OnCore: Online Collaborative Research Environment (OnCore) is a web based, comprehensive clinical trial management system (CTMS). OnCore will support our investigators and research coordinators as a centralized place to manage all of their study protocols and subjects. The goals of implementing OnCore across the School of Medicine are:

To improve day to day workflows
To improve subject safety
To improve budget and financial management
To have more robust strategic planning within departments and as an institution
To increase transparency and institutional oversight

For support: oncoresupport@uvahealth.org or 434.297-5757, Option 1

https://www.medicalcenter.virginia.edu/intranet/cto/oncore-help