Introduction

Introduction

Congratulations! You have successfully accessed the ResearchGo Virtual Regulatory Binder sponsored by the UCLA CTSI Office of Regulatory Affairs. We thank Partners Healthcare for providing this invaluable resource so it could be modified for use at UCLA. This binder is applicable for behavioral, FDA, and non-FDA regulatory compliance.

Purposes of the Binder

The ResearchGo Virtual Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:

1. Guidance for organization and record keeping.
2. Assistance with proper study documentation and successful study management, including guidance on electronically stored records. 
3. Links to on-line resources, such as the UCLA Institutional Review Board (IRB) policies, guidelines, and forms, the Clinical Research Resource ResearchGo, institutional policies, good clinical practices, and Federal Regulations.

Whom to Contact for Help

UCLA CTSI Regulatory Affairs provides individual consultation and educational offerings to both new and experienced members of the research community, including investigators and study staff. To schedule a binder consultation for FDA and non-FDA regulated research, please contact Uma Ganapati.
 

Florence eBinders

Florence eBinders, an electronic regulatory binder system designed to streamline management of study regulatory binders and enhance efficiency.  Available for use as of April 22, 2024.

Benefits of Florence eBinders for Clinical Research:

1. Enhanced Accessibility: Access regulatory documents anytime, anywhere, with secure cloud-based storage, ensuring seamless collaboration among research study team members and external monitors.
2. Improved Efficiency: Say goodbye to manual paperwork and tedious document searches. Florence eBinders automates document management and workflows, saving time and reducing errors.
3. Real-Time Tracking: Track document status, assigned tasks & signatures, and changes in real-time, empowering you to stay informed and in control of your regulatory compliance efforts.
4. Advanced Security: Rest assured knowing your sensitive regulatory documents are protected by robust security features, access controls, and audit trails.
5. On Demand Support: Get help when needed. In addition to accessing online reference materials and videos, you can engage in instant messaging with the vendor support team.

Take a sneak peek at Florence eBinders in action! Click on the following link to watch a video demonstration:

• Florence eBinders Overview

How to obtain eBinders Access:

• Study Team users can obtain eBinders access once they are authorized for access by their department authorizer, have taken applicable access specific training, and are listed as active staff under applicable roles for the study.
  
  • eBinders Access Levels & Training
• External Monitors can obtain eBinders access once they have taken applicable training, have submitted all required forms to the CTSI-ORA team, and have had their access window set by the Regulatory Coordinator in eBinders.
  
  • Sponsor Monitoring and Auditing for Clinical Research Studies
  • Remote and On-Site Monitoring FAQs
• Please review the eBinders FAQs linked below for additional information.

What to expect starting April 22^nd, 2024:

• eBinders training will become available for study team users to complete in Cornerstone.
• Departments can work with their department authorizers to submit eBinders access authorization for approved users.
  
  • Department Authorizer Lookup
  • For Department Authorizers: Research Authorization Forms for OnCore & eBinders Access
• Regulatory Coordinators and Program Managers who are provisioned with Level – 4 access in eBinders can begin to interface their studies from OnCore into eBinders and manage their department central folders, assign eISF structure templates to their study folder, and start managing their regulatory binder in eBinders for their assigned studies.
  
  • Regulatory Coordinator Tasks & Responsibilities for eBinders
• Study team users who are provisioned for eBinders access can begin to reference and perform role specific tasks on their applicable studies in the application.

Questions?

A list of Frequently Asked Questions (FAQs) is available and linked below, to provide more information about Florence eBinders and how it can benefit study teams.

• Florence eBinders FAQs

For additional assistance with eBinders, please email CRIShelpdesk@mednet.ucla.edu.