Florence eBinders
Florence eBinders is a cloud-based platform designed for clinical trials, that is a fully validated FDA 21 CFR Part 11, HIPAA, ICH-GCP and GDPR-compliant service. It includes tools like digital signatures, redaction, eLogs and placeholder reporting.
Florence eBinders offers a range of project management tools. The electronic format allows for forwarding correspondence directly into eBinders via email, eSignatures, redacting/de-identifying and annotating source documents, and setting expiration dates on documents to improve efficiency and reduce duplication. Customisable Roles and Permissions allow for greater oversight of document management.
All international investigator initiated clinical trials sponsored by MCRI must use Florence eBinders to ensure that they are fully FDA 21 CFR Part 11 and GDPR compliant.
Key benefits of Florence eBinders
- Eliminate paper binders
- Electronic signature and log requests
- Multi-site management
- Save time
- Remote monitoring
- Easy digital archiving
Interested in using Florence eBinders for your research?
Sign up to access Florence eBinders for your clinical trial research. Sign up.
Contact us
For any questions, please email us at [email protected].
Resources
According to MCTC100 | Florence User Policy, all users must complete three steps before gaining access to their study binder:
- Training: Complete training on how to use Florence eBinders.
- Wet Ink Signature: Create an original record of the user’s wet ink signature and provide both digital and hard copy to Florence Administrator.
- Wet Ink Signature Page (MCRI / RCH staff – originals sent to MCTC, South Building Level 4)
- Monitor We Ink Signature Page (Site Monitors – original sent to MCTC South Building Level 4 during first visit)
- Wet Ink Signature Log (Non MCRI/RCH staff based at external sites– originals kept with Site Coordinator)
- Role and Permissions: Organise appropriate roles and permissions with the Organisation Administrator via email or the project’s Binder Administrator. Contact [email protected] for support.
For additional guidance on completing Florence training, including wet-ink signature pages and accessing your binder, please refer to the MCTC225 | Florence External User Handbook.
The below filing structure guidance documents and table of contents provide a clear, standardised framework for organising essential trial documents within a binder. They ensure consistency, completeness, and regulatory compliance by guiding what documents belong in each section.
The MCTC225 | Florence External User Handbook provides guidance for Florence eBinders™ users on the consistent and appropriate use of the Florence platform for clinical research studies conducted at the Melbourne Children’s Campus. It consolidates practical guidance, tips, and best practice instructions into a single, accessible reference to support efficient and compliant document management.
The Handbook covers the following topics:
- Requesting a New Florence
- New User Accounts
- Navigating Florence eBinders
- Access Management
- Document Management
- Annotations, Redactions and Signing
- eLogs
- Reporting Tools