Florence eBinders
Manage the regulatory aspects of your studies from anywhere with Florence eBinders. The tool replaces paper forms and physical binders, giving research teams an efficient, compliant way to electronically sign, manage, store, and collaborate on study documents.
CTSI’s regulatory specialists have been using eBinders for all new studies they support as of August 3. The tool will become available to all health sciences studies at the University of Minnesota in Fall 2020. eBinders at UMN
Training: November 16
12-2:30pm
via Zoom
Remote data access
Access study files and binders from anywhere in a secure, user-friendly way.
Reduced administrative burden
Compared to physical binders, eBinders give study teams a faster, easier, and more standardized way to create, manage, retrieve, store, and archive a study’s documents.
Electronic signatures
A simplified electronic regulatory binder signature process saves time and reduces hassle for the study team, while ensuring 21 CFR part 11 compliance. With eBinders, study teams no longer need to physically transport paper documents from person to person.
Remote monitoring
Give monitors the documents and tasks they need to securely monitor studies from anywhere (on- or off-site).
Eased compliance
eBinders is designed for HIPAA and 21 CFR part 11 compliance. Reminders and a user-friendly dashboard make it easy to identify expired documents and other items that are approaching compliance deadlines.
Streamlined document updating
Upload documents once and push them to multiple study binders. This makes it easier to ensure binders have correct, up-to-date documents (e.g., CV, medical licenses) for people associated with the study.
OnCore interoperability
OnCore will interface with eBinders, making it easier to create new binders and ensure appropriate access credentials are pushed to binders.
Implementation at UMN
CTSI is helping to bring Florence eBinders to the University of Minnesota as part of its ongoing commitment to streamline and enhance the way research is conducted. CTSI partnered with the Medical School to purchase the tool and is leading its UMN-wide implementation.
Timing
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August: New studies supported by CTSI’s regulatory specialists and Masonic Cancer Center’s Clinical Trials Office (CTO) studies.
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Fall 2020: Broader UMN community.
Users
- PIs
- Clinical research coordinators
- Project managers
- Regulatory specialists
- Monitors
Cost
We are currently exploring options to recover the cost of the tool. Many sites can recoup costs by charging industry sponsor fees, which is one of several options being considered.
Using eBinders
Access and contact
eBinders is currently only available to:
- Studies supported by CTSI’s regulatory specialists.
- Studies through the Masonic Cancer Center’s Clinical Trials Office (CTO).
Email us at eBinders@umn.edu with questions or to invite team members to your binder.
