Florence eBinders

Monthly Research Systems Drop-In Sessions

Stop by our live monthly Q&A drop-in sessions and talk with the Florence Support Team.

No RSVP needed – Add to your calendar today!

Every second Wednesday of the month from noon - 1:00 p.m.

Add to your calendar (ICS)

OnCore required workflow for subject consenting when using Florence.

View Workflow (PDF)

1. New User Access / Training 

• Staff eBinder Training Companion Guide (PDF)
• Investigator eBinder Training Companion Guide (PDF)
• Attestation Form (PDF)
• Individual Signature Log (PDF)
• ePrinter Installation (PDF)

2. eBinders Justification Links (also available in Central Resources binder in Florence)

• MCW Florence eBinder Use (PDF)
• MCW Florence eBinder Fee Justification (PDF) Login Required
• MCW Florence eRegulatory Justification (PDF)

3. Sponsor Documents 

• Letter of Nonrepudiation (PDF) 
• 21 CFR Part 11 External Audit Certificate (PDF) 
• eBinder Compliance Summary Memo (PDF)

4. IRB Application Language to Allow for Use of eBinders

• Collaborative Guidance Regarding Impact of Use on MCW IRB Applications  (PDF) 
• SmartForm & Consent Inclusions (PDF)

Quick references to complete the most frequently requested Florence eBinder functions. Reminder, if you do not locate a guide for the function you are seeking, go to the 'Need Help?' section in Florence to review up to date articles, videos and other references on completing the many Florence e-Binder functions.

• Document Restrictions (PDF)
• eSignatures Workflows Guidance (PDF)
• Create a Certified Copy in Florence (PDF)
• Procedure to Modify FDA Forms (PDF)
• Process of Signing Using Different Options (PDF)
• Training Companion: Manage Your Study eBinders (PDF)

For further assistance, email Florence Support.

If you are not sure where to place documents in your study eBinder, we have created a Mapping Guide for each MCW template for easy reference. The Mapping Guides will breakdown the branches of each MCW template folder and provide clarifications and/or guidance for use of specific documents or subfolders.

For further assistance, email Florence Support.

Basic Footprint Mapping Guide (PDF)

Florence eBinders will provide an accessible, transparent, cloud-based central repository for all essential regulatory documents to accelerate new study startup and support sponsor access for remote monitoring.

Prior to being provided access to the MCW Florence eBinders Production environment, sponsor/CRO monitors must complete the required training components for MCW to maintain compliance with Federal regulations (21 CFR Part 11) and HIPAA requirements.

For further assistance, email Florence Support.

View Guide (PDF)

This Standard Operating Procedure (SOP) describes the identification and storage of regulatory Essential Documents for clinical research studies and trials in Florence eBinders™ and to establish the process by which an MCW Principal Investigator (PI) or their designee delegates study-related responsibilities to applicable personnel and by which necessary information about each team member’s involvement in the study is maintained.

View SOP (PDF)

Florence eBinders™ is a secure, FDA Part 11 and HIPAA-compliant system that replaces paper forms and physical binders, giving research teams an efficient, compliant way to electronically sign, manage, store, and collaborate on study documents and to facilitate remote monitoring.

• View Tips on Announcements (PDF) 
• View Tips on Audit Trails (PDF) 
• View Tips on Bulk Signature Requests (PDF) 
• View Tips on Creating Documents (PDF) 
• View Tips on eLogs (PDF) 
• View Tips on ePrinter (PDF) 
• View Tips on Permissions (PDF) 
• View Tips on Tasks (PDF)

The required fields must always be entered (either by study staff or OnCore support staff) to create the protocol shell. For more info, please see linked support documentation.

Protocol Fields Required (PDF)

Florence eBinders™ supports integration with OnCore™, MCW's enterprise Clinical Trials Management System, for the automated creation of basic binder folder structures and study team roles in eBinders.

View Integration (PDF)