Florence eBinders: Non-Oncology FAQs

Logging in to eBinders

Question: What can I use the Training environment to do?
Answer: UAT (User Acceptance Testing) can be used to complete training activities and practice using the system.

Question: Is UAT connected to the OnCore training environment?
Answer: Yes, UAT is currently connected to the OnCore training environment.

eBinders Utilization

Question: Who should be using eBinders?
Answer: Oncology began piloting the use of eBinders in December 2021. It was rolled out to Non-oncology in Summer 2022.

Question: I see Regulatory and Subject folders in the eBinders templates and my role does not typically fall under either of those umbrellas. Where do I put documents related to things like activation and sponsor/CRO monitoring?
Answer: Regulatory is a bit of a misnomer and it is best to think of the Regulatory folder as containing things that are not subject related, as opposed to regulatory agencies/bodies. The documents contained in the question belong in the Regulatory folder.

Question: To what extent is eBinders taking over the use of physical binders and other electronic storage locations (e.g., shared network drive)?
Answer: The answer to this question is complex, and it may be best to think about eBinders as replacing the physical binders we once kept. In other words, if you have a final version of a document that you would have filed in the physical binder and provided to a monitor/auditor/inspector, it would get filed in eBinders, but if you have a temporary or working copy, or something you would not make readily available to monitors/auditors/inspectors, you'd likely keep it in the shared network drive. Two examples include:

• IIT protocol in development - maintain this in the shared network drive as it is being developed. File the final version of the IRB-approved protocol in eBinders for access via a deeplink within the Documents tab in OnCore.
• Your working copy of draft HealthLink (Beacon) Build - maintain this in the shared network drive because it is a working copy. File the final version in eBinders upon completion.
• Internal audit or review report - maintain this in the shared network drive because it doesn't need to be readily available to monitors/auditors/inspectors, and could be provided to them upon request, as applicable.

eBinders and PHI

Question: Can I put documents containing PHI into eBinders?
Answer: Yes and it is imperative that you mark those documents as CONTAINING PHI, as that impacts who can view and/or download them.

Question: Can monitors view and/or download documents marked as containing PHI?
Answer: Monitor permissions allow them to VIEW documents marked as containing PHI, but they CANNOT download them. Again, this makes it imperative that you mark PHI containing documents as such.

Question: A document marked as containing PHI isn't showing a preview for the monitor, but it says "Download to view." Can they download the document?
Answer: No, the italics show that the word Download is NOT a hyperlink and nothing will happen if they try to click it. For users who can download documents containing PHI, the message would be "Download to view," and the word Download would be a clickable hyperlink.

Question: Can you mark FOLDERS as containing PHI?
Answer: Unfortunately, this is NOT possible in eBinders. Instead, each PHI containing document must manually be marked as such.

Central Documents eBinder

Question: What documents are maintained in the Central Document eBinder?
Answer: Central Documents includes:

• eBinders administrative documents including templates and statement of use
• Lab documentation (e.g., CAPS, CLIAs)
• Folders for training documentation for study team members, including clinical staff and investigators

eBinder Structure Template

Question: What do I do if my study has pre-screening and main consents but there is only one consent placeholder in the consent folder?
Answer: It is acceptable to upload more documents than what is outlined in the placeholders created by the folder structure templates. The placeholders are intended to show people where things should be filed, if applicable, and NOT to limit the contents.

Question: What is the purpose of the "PRC" folder within the Subjects folder, when there is already a Drug or Device Accountability Records folder?
Answer: The "PRC" folder could be used for other non-subject specific communications with PRC. For example, during the activation process of an IIT that requires a pill diary, you send it to PRC for their review, you would file their response here. The "Drug or Device Accountability Records" folder is used, specifically, for accountability records.

Question: What is the rationale for having a "HealthLink Builds" sub-folder under PRC in eBinders?
Answer: Historically, these documents were typically filed on the shared network drive (e.g., G drive or J drive) and with the implementation of eBinders, they should be filed in the folder noted above instead. This also allows auditors to view these documents as needed, which was previously done by uploading them to OnCore as needed.

Question: What is the rationale for having a "Drug Order Forms" sub-folder under PRC in eBinders? Which groups and/or studies use this?
Answer: If a study provides electronic or paper copies of drug order forms, such as those that outline the IVRS/IWRS questions or instructions.

Question: What is the rationale for uploading ICF/HIPAA documents into eBinders when they already get scanned into the electronic medical record (EMR) and stored on paper?
Answer: There are several reasons for this:

• Ease of locating - finding these documents in the EMR can be challenging if the uswer does not already have the date on which the consent was signed.
• "Interim" versions - ideally, only the completely signed (e.g., by the prospective participant and person obtaining consent) would be uploaded into the EMR. Because the consent process can include "interim" versions that do not yet have all the required signatures, especially in the remote setting, these will be maintained within eBinders.
• Some studies have consent forms that do not get uploaded into the EMR, such as healthy volunteers or caregivers, and this way we can be consistent in putting them into eBinders.

Question: What do I do if my study binder has two Financial Disclosure Form folders?
Answer: There are several studies that have Financial Disclosure Form folders in both the Regulatory and the Regulatory > Personnel Qualification and Training folder. If you encounter this, it is acceptable to delete the redundant folder in the Regulatory > Personnel Qualification and Training folder. If you do not have permission to delete folders, contact the study Regulatory team member who can assist.

File Formats in eBinders

Question: If I plan to upload a PDF created from an email into eBinders, should I create it using "Save as Adobe PDF" or "Print" to PDF?
Answer: Use "Print" to PDF. PDFs created by using "Save as Adobe PDF" become PDF Portfolio files and these are incompatible with eBinders and won't display properly.

Additional Resources

• Florence eBinders Informational Session Recording (06/22/22)
• Florence eBinders Informational Session Slide Deck (06/22/22) (PDF)