Clinical Trial Management System Operations
Florence eBinders
The Florence eBinders system provides a comprehensive digital solution to streamline documentation, facilitate compliance, and ultimately foster a more efficient research environment. This effort underscores a shared commitment to advancing research innovation and improving operational workflows across all related departments and units. 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.
The CTSC is helping to bring Florence eBinders to UC Davis Health as part of our ongoing commitment to enhance and optimize research processes, leading the deployment and integration of this advanced tool across the entire UC Davis Health campus. Note that the UC Davis Comprehensive Cancer Center Office of Clinical Research (OCR) has their own Florence environment. Reach out to the OCR Florence contacts Annika Bryant at abryant@ucdavis.edu, or Kevin Chun at kcchun@ucdavis.edu, for cancer related studies.
The use of Florence e-Binders for your research studies is optional.
Common Users:
PIs
Clinical Research Coordinators
Clinical Research Supervisors
Project Managers
Regulatory Specialists
Monitors
Features
OnCore will interface with eBinders, making it easier to create new binders and ensure appropriate access credentials are pushed to binders.
Access study files and binders from anywhere in a secure, user-friendly way.
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.
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.
Give monitors the documents and tasks they need to securely monitor studies from anywhere (on- or off-site).
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.
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.
Information and Resources
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Rates and Budget Justification
Sponsor industry trials will cost of $1,200 per study. You can add this cost as a line item in your study budget. To help justify and negotiate this line item in your study budget, please refer to the Sponsor Memo Template.
There will be no cost for investigator-initiated trials or federally funded trials. Please reach out to the Florence team for additional recharge information.
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Training and Access
All users are required to complete Florence eBinders training before granted access to the UC Davis Health Florence environment.
For training and registration, please reference the Florence End-User Training Guide and Florence eBinders Training Account Registration.
A dedicated training web page is coming soon.
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Florence eBinder Request Instructions
To request an eBinder for your study, use the OnCore Intake Form and select Florence eBinders as your service request.
- If your study requires OnCore entry and you would like to request an eBinder, submit the eBinder request via the OnCore Intake Form when you are ready to request the OnCore build. Best practice is to submit a request during the study startup phase.
- If your study does not require OnCore entry and you would like an eBinder, submit the eBinder request via the OnCore Intake Form and only select Florence eBinder.
You may submit your eBinder request at any time for studies that do not require OnCore entry. For guidance on completing the OnCore intake form, please refer to the working instructions for Redcap intake form.
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Resources
A dedicated resource web page is coming soon. In the meantime, Florence Help Desk offers further instructions and helpful articles.
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Florence Office Hours
Bi-weekly on Fridays, beginning January 24, 2025, noon to 1 p.m. via Zoom
Reference the CTSC event calendar for specific dates.The CTSC Clinical Trial Management System Operations Office offers Florence office hours to provide complimentary assistance with the following:
- What is Florence and how it can benefit you
- How to get started, training and access
- How to request Florence eBinders
Drop in to bi-weekly office hours or email HS-FLORENCEeBINDERS@ucdavis.edu to schedule an appointment.
Email questions in advance to HS-FLORENCEeBINDERS@ucdavis.edu. -
Florence Team
JoAnna Leon
CTMS Ops Intake Project Manager & Florence Implementation Lead
jclramirez@ucdavis.eduApril Cuellar, CCRP
QA/QC Program Manager & Florence Implementation Lead
ammedina@ucdavis.eduSuzan K. Bruce, CPC
CTMS Associate Director & Florence Administrator
skbruce@ucdavis.eduErinn Watson
CTMS Ops - Research Administrator III & Florence Administrator
eamwatson@ucdavis.edu