Florence eBinders

person typing on a laptopManage 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. 

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.

Simple filing 

Send anything directly to your regulatory binder with the Florence ePrinter tool. This makes it easy for research teams to file PDFs, correspondence, and other important binder contents.

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. 

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.

Support

Getting started

Using eBinders

Compliance

Access and contact

Log in

Email us at eBinders@umn.edu with questions or to invite team members to your binder.

Training

To access eBinders, staff and faculty must complete the required training. How it works:

  1. Online training is assigned by each department’s designated superuser.

  2. Interested staff and faculty take the training at training.umn.edu.