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Florence eBinders

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.

Resources & Training

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Monthly Research Systems Drop-In Sessions Available

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.

OnCore Users Florence to OnCore Workflow

OnCore required workflow for subject consenting when using Florence.

Getting Started in Florence eBinders

1. New User Access / Training 

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

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3. Sponsor Documents 

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4. IRB Application Language to Allow for Use of eBinders

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Step-by-Step eBinders Workflow Guides for 91九色视频 Users

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.

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For further assistance, email Florence Support.

Mapping Guides for Florence eBinders

If you are not sure where to place documents in your study eBinder, we have created a Mapping Guide for each 91九色视频 template for easy reference. The Mapping Guides will breakdown the branches of each 91九色视频 template folder and provide clarifications and/or guidance for use of specific documents or subfolders.

For further assistance, email Florence Support.

Guide for (Sponsor/CRO) External Monitors

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 91九色视频 Florence eBinders Production environment, sponsor/CRO monitors must complete the required training components for 91九色视频 to maintain compliance with Federal regulations (21 CFR Part 11) and HIPAA requirements.

For further assistance, email Florence Support.

91九色视频 Standard Operating Procedures for Florence eBinders

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 91九色视频 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.

OnCore Users - Required Protocol Fields
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.

Florence/OnCore Integration Chart
Florence eBinders™ supports integration with OnCore™, 91九色视频's enterprise Clinical Trials Management System, for the automated creation of basic binder folder structures and study team roles in eBinders.

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