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Electronic regulatory binder tool now available to UMN researchers

November 17, 2020

Florence eBinders is now available at the University of Minnesota, enabling health sciences study teams to replace paper forms and physical study binders with a digital option. The electronic regulatory binder tool gives PIs and study teams a faster, easier way to electronically sign, manage, store, and collaborate on a study’s regulatory documents.

CTSI helped 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.

Simplifying study tasks

Florence eBinders streamline workflows for study teams, while making it easier for them to  perform key activities from anywhere.

“Since implementing Florence, the majority of our forms have been completed and signed within hours,” says Erica Orcholski, CCRP, Regulatory Manager of the Masonic Cancer Center’s Clinical Trials Office. “In addition to being fast, eSignatures eliminated the risk of formatting errors and lost forms.”

Benefits include:

  •     Remote access to regulatory files and binders.
  •     Reduced administrative burden.
  •     Ability to obtain electronic signatures while ensuring 21 CFR part 11 compliance.
  •     Remote monitoring capabilities.
  •     Streamlined document updating; CVs, medical licenses, and other documents can be uploaded once and pushed to multiple study binders.
  •     OnCore interoperability, which makes it easier to create new binders and ensure appropriate access credentials are pushed to binders.

Achieving efficiencies

Currently, there are multiple processes for storing, maintaining, and archiving regulatory documentation across both paper binders and various electronic secure file storage systems.

With Florence eBinders, the University of Minnesota can standardize processes and data storage, achieve greater efficiencies, and better manage risk.

Accessing eBinders

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

  • Online training is assigned to faculty and staff by their department’s designated superuser.
  • Interested staff and faculty take the training at training.umn.edu.

Contact [email protected] if you have questions.