Florence

Florence e-Consent

Florence e-Consent is a 21 CFR Part 11, HIPAA, CCPA, and GDPR compliant system that is easy to use for researchers, subjects, and research monitors. With Florence you can easily invite participants into the e-Consent platform, monitor the status of participants’ informed consent in real-time, update to latest consent versions for new protocol amendments, distribute and track re-consenting in the same application, and more!

If you are interested in utilizing e-Consent for your future studies, please follow the steps below:

  1. E-mail Melissa Vliet (mvliet@mfa.gwu.edu) requesting an account be set up for you. The account has to be set up using your GW email! 
  2. A member of the OCR regulatory team will register your account 
  3. Register for ‘Florence Basics for Remote Site Access’ and complete the training here.
  4. Download the completion certificate, store it in your regulatory files, and send a copy to mvliet@mfa.gwu.edu.
  5. After the certificate is received by the OCR, an Attestation of Florence e-Consent Training Completion will be routed through Florence for your e-signature. Again, please download the document and save it in your regulatory files.

Florence eBinders

The OCR has brought Florence eBinders to the George Washington University as part of its ongoing commitment to streamline and enhance the way research is conducted. Florence e-binder is a tool that replaces paper forms and physical binders, giving research teams an efficient, compliant way to electronically sign, manage, store, and collaborate on study documents. Florence e-binder is validated 21 CFR Part 11 and HIPAA compliant service that manages bother regulatory and source documents.

Florence e-consent was implemented in the summer of 2023, which can be used in conjunction with e-binders to electronically manage the consenting process for participants.

Features

  • Remote data access: Access study files and binders from anywhere in a secure, user-friendly way.
  • Remote monitoring: Give monitors the documents and tasks they need to securely monitor studies from anywhere (on- or off-site).
  • Reduced administrative burden: 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.
  • Streamlined document updating: 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.
  • Electronic signatures: 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.
  • OnCore interoperability: OnCore will interface with eBinders, making it easier to create new binders and ensure appropriate access credentials are pushed to binders.
  • Eased compliance: 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.
  • Simple filing: 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.

Users

  • PIs
  • Clinical research coordinators
  • Project managers
  • Regulatory specialists
  • Monitors

Training and Access

Before you can access Florence eBinders, you will need to have completed training.  See below for training requirements based on your role.  In addition, investigators and other study staff members will need to have GW credentials established (a GW UserID and email address) in order to log in to the system.

New users will need to:

  1. Email mvliet@mfa.gwu.edu with your GW UserID.
  2. Complete the relevant training course selection in Florence Academy.
    1. For investigators: PI Training
    2. For coordinators and regulatory staff: Training for Study Staff
    3. For monitors: Training for Monitor
  3. When finished, send your certificate of completion (which you can download as a PDF after finishing your courses) to mvliet@mfa.gwu.edu.
  4. Once your account is set up, you will need to electronically sign a training attestation form within the system.  You will receive an email at your GW email address prompting you to access eBinders in order to sign the form (you will also be prompted to set up a signing PIN).  After you've signed the training attestation form, the Site Admin will finalize your account, and you can start using eBinders.

For technical issues, please complete the System Assistance Request Form.