Paper forms and physical study binders will soon be replaced by an electronic regulatory binder tool, thanks to the implementation of Florence eBinders at CTSI. The tool gives PIs and study teams an efficient, secure way to electronically sign, manage, store, and collaborate on a study’s regulatory documents.
Starting August 3, eBinders will be used for all new studies supported by CTSI’s regulatory specialists.
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.
Simplifying study tasks
Florence eBinders streamline workflows for study teams, while making it easier for them to perform key activities from anywhere:
Electronic signatures: Simplifies the regulatory binder signature process, 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: Gives monitors the documents and tasks they need to securely monitor studies from anywhere.
Updating documents: Makes it easy to identify expired documents and other items that are approaching compliance deadlines, thanks to reminders and a user-friendly dashboard. Plus, documents and credentials can be pushed to multiple study binders, further streamlining updates.
Study start-up: OnCore will interface with eBinders, making it easier to create new binders and ensure appropriate access credentials are pushed to binders.
Demo: July 29
To see a demo, we invite you to attend our eBinders seminar on July 29 at 12pm.
CTSI’s regulatory specialist team will provide training details and other information to study teams who begin a new study supported by their team after August 3. In the meantime, study teams do not need to take action.
eBinders will become available to all health sciences studies at the University of Minnesota in Fall 2020.
To ensure a successful UMN-wide rollout, the tool is being piloted within CTSI and the Masonic Cancer Center’s Clinical Trials Office (CTO) in late summer 2020. A small pilot will ease adoption for other groups, ensure the tool and its integrations are working appropriately, help to define workflows, and build expertise among our regulatory team so they can support other users as they go live. Ultimately, a pilot enables us to implement the tool across UMN as quickly as possible.