Live since March 1st, 2024
The UW Medicine Clinical Trials Office (CTO) has implemented UW Florence, the University of Washington’s electronic regulatory management platform, for clinical research studies conducted at UW, excluding hematology and oncology studies. UW Florence includes both Florence eBinders and Florence eConsent.
The UW Florence eBinders system integrates with OnCore CTMS, enabling automated study binder creation and user permission assignments based on information maintained in OnCore.
eBinder creation is managed through this integration and is determined by the study’s designated OnCore Management Group through the selection of the appropriate binder type. As part of the integration, protocol-specific Florence eBinders roles are automatically assigned based on mapped staff roles in OnCore.
Florence serves as the system of record for regulatory documentation. While use of the Florence platform is strongly encouraged due to its efficiency and support for regulatory compliance, adoption is not mandatory. Study teams may determine whether and when to implement Florence for their studies.
Project Goals & Timeline
FILE MANAGEMENT
- Eliminate paper binders. Manage and store regulatory, source, business, and other clinical research documentation securely in a 21 CFR Part 11 compliant system.
- Easily assign user roles and set up study binders with a consistent filing structure based on preset templates.
- Efficiently produce, sign, and manage electronic Delegation of Authority and other logs.
- Allow the system to keep track of and remind users about document expiration dates, renewals, and other due dates.
- Locally manage access to files and functional permissions, keeping user data safe and secure.
TIME MANAGEMENT
- Shifting to a web-based platform allows Investigators (PIs) and study teams to manage binders, review, and electronically sign documents securely from anywhere, using any device.
- No more waiting to corner PIs in clinic hallways with papers to sign that they have no time to review. PIs can review and sign documents on their own schedule.
- The electronic signature process is easy and quick.
- Documents are always updated in real-time and across all study binders where applicable.
REMOTE MONITORING
- Efficiently enable compliant, secure, and permission-controlled remote monitor access.
- Full audit trails assist with monitoring and verification of changes.
TRAINING AND TECHNICAL SUPPORT RESOURCES
- Robust online training library and resources.
- Focused training for PIs makes onboarding quick and easy, approximately 15 minutes.
UW Florence Resources
- UW Florence Website for UW-specific information and FAQs
- Florence Vendor Help Desk for articles and how-to guides
- UW Florence Request Form for UW Florence questions and requests
Note: The Hematology & Oncology Division utilizes the Fred Hutch instance of Florence.