Florence eBinders and eConsent

Florence eBinders and eConsent

About Florence eBinders

GW has chosen to adopt Florence eBinders in order to enhance the efficiency of clinical research at our institution.  Florence eBinders is a validated, HIPAA and 21 CFR Part 11 compliant e-regulatory system that allows for the secure storage, management, and signing of electronic study documents.  Remote monitoring is also supported.  The use of Florence eBinders will enable us to move away from reliance on paper forms and physical study binders, thereby improving the clinical documentation workflow and reducing the time it takes to get required signatures.  This, in turn, will help to reduce study start-up time.

We have also adopted Florence eConsent, which can be used in conjunction with eBinders to electronically manage the consenting process for participants.  Please see the eConsent tab above for more information on this system and gaining access.

 

Log in to Florence eBinders     Training Videos     eBinders Help

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. Complete the relevant training course selection in Florence Academy.

For investigators: PI Training

For coordinators and regulatory staff: Training for Study Staff

For monitors: Training for Monitors

2. When finished, send your certificate of completion (which you can download as a PDF after finishing your courses) to oncore@gwu.edu

3. 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.

Frequently Asked Questions (FAQs)


Does OnCore integrate with eBinders?

Yes, OnCore does integrate with eBinders.  Study folders in eBinders will be created based on a field filled out in OnCore within the Annotations tab of PC Console, and links to documents stored in eBinders will exist in OnCore.

What browsers can I use to access eBinders?

Chrome and Edge are recommended.  Internet Explorer is not supported, and Safari and Firefox are not recommended.

Why can't I see the binder, folder, or document I'm trying to view?

This is likely related to not having the right permissions to view the item in question.  If you aren't seeing something in eBinders that you expect to see, please reach out to us at oncore@gwu.edu and let us know.

Where can I get help with eBinders or eConsent?

You can email us at oncore@gwu.edu with any specific questions, or you can access the Florence help portal from within eBinders or eConsent by clicking on your username in the upper right of the screen and selecting the "Need Help?" option.  The Florence help portal can also be reached here, although you will need to be logged in to eBinders or eConsent to access it.


 

 

About Florence eConsent:

Florence eConsent is a validated system compliant with 21 CFR Part 11 and HIPAA that allows for consenting participants electronically.  It is simple to use, imitates the paper consenting workflow, and includes a participant portal that enables participants to review and sign their informed consent forms on any device, at any time.  eConsent now also supports tablet-based in person signing for participants.  Clinical staff can view the progress of participants' informed consents in real time and can countersign from within the system.  In addition, the system supports remote monitoring.
 
 
Note: if you have access to both eBinders and eConsent, upon logging in you will be asked to choose which application you would like to go to.  You can switch from one to the other within either application by clicking your name in the upper right and selecting "Switch Products."

Training and Access

Gaining access to eConsent is similar to gaining access to Florence eBinders.

New users will need to:

1. Complete the relevant training course selection in Florence Academy.

Course selection for all new users: eConsent for End Users

2. When finished, send your certificate of completion (which you can download as a PDF after finishing your courses) to oncore@gwu.edu

3. Once your account is set up, you will need to electronically sign a training attestation form within eBinders.  After you've signed this form, the Site Admin will finalize your account, and you can start using eConsent.

Frequently Asked Questions (FAQs)

Does eConsent integrate with eBinders?

Yes, eConsent does integrate with eBinders.  Consent forms signed in eConsent can be moved to a specified location in eBinders.

What languages does eConsent support?

Currently, English and Spanish are supported.