Training Environment and Videos

Question: What can I use the TRAINING environment to do?
Answer: Within the TRAINING environment, also called UAT (User Acceptance Testing), you can use the EREGPRACTICE - Boysen, Erin binder to complete training activities and practice using the system. There are mock subject documents available in this Box folder with which you can practice. Similarly, there are mock regulatory documents available in this Box folder.

Question: Is the TRAINING environment cleared for the inclusion of PHI? 
Answer: No, do not upload/enter PHI into the TRAINING environment. This is primarily due to how the access to has to be set up. As noted above, use the mock documents to practice in this space to avoid accidentally uploading/entering PHI. 

Question: I was practicing in the TRAINING environment and now my documents and elogs disappeared - what happened?
Answer: The TRAINING environment is cleaned out every 30 days or so (typically the first week of the month) to ensure there is not a build up of documents and to remove any PHI that may have been added erroneously.

Question: Is the TRAINING environment connected to OnCore in any way?
Answer: As of 9/1/2024, the TRAINING environment is no longer connected to OnCore. If you need help understanding how eBinders interfaces with OnCore (both production environments), refer to the Connection with OnCore section of the Florence eBinders: Resource Library.

Question: Is the investigator training video available for viewing? Also, how long is it?
Answer: Yes, the approximately 10 minute UW-specific investigator training video is available for viewing (requires multiple clicks and UW NetID to login.

Question: Is the monitor training video available for viewing?
Answer: Yes, the approximately 10 minute, UW-specific monitor training video is available for viewing (requires multiple clicks and UW NetID to login).

Connection with OnCore

Question: How long does it take for things (e.g., new binder creation, mapped roles) to send from OnCore to eBinders?
Answer: It may take up to 3.5 hours for the above actions. If you have been waiting longer than 3.5 hours, submit a Jira ticket.

Question: How long does it take for things (e.g., deeplinks) to send from eBinders to OnCore? 
Answer: It may take up to 30 minutes for the above actions. If you have been waiting longer than 30 minutes, submit a Jira ticket. 

Question: Is the TRAINING environment connected to OnCore in any way?
Answer: As of 9/1/2024, the TRAINING environment is no longer connected to OnCore. If you need help understanding how eBinders interfaces with OnCore (both production environments), refer to the Connection with OnCore section of the Florence eBinders: Resource Library.

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: Is using eBinders to manage our department, center, institute, or research group standard operating procedures (SOPs) allowed? 
Answer: No, SOP management, including drafting, routing for review, approval, or eSignatures, and long-term storage is not allowed. If evidence of these activities is found, the study team will be contacted and given 2 business days for deletion. The study team may also have their binders closely monitored thereafter. It is acceptable to use your study-specific binder in eBinders as a temporary, short-term shared location to provide sponsors/monitors with copies of SOPs. Departments, centers, institutes, or research groups are responsible for having procedures in place for the sharing process, which typically occurs at the time of monitoring visits. The study team must delete the SOPs from eBinders after the short-term sharing period.

Question: If SOP management in eBinders is not allowed, why are there SOPs in the Central Documents binder for select ancillary services?
Answer: Select SOPs for some ancillary services are allowed in the Central Documents binder because they are frequently shared with sponsors/monitors across a large swath of studies. Leadership determined that dedicating resources to the management of this limited number of SOPs was worth the benefit in time saved across study teams. Refer to the Florence eBinders: Central Documents eBinder UW User Guide for more information.

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.

Question: Do monitors need to be physically located in the US to access eBinders?
Answer: Monitors do not need to be physically located within the United States (US) to access eBinders; however, this is a requirement for Health Link (HL) access. Because of this discrepancy, research groups would need to print and certify documentation from HL into eBinders for monitoring purposes. We recommend each department, center, institute, or research group have a way to track international access requests in the event that they need to renegotiate monitoring fees because of the extra burden this creates. 

eBinders and PHI

Question: Can I put documents containing PHI into eBinders?
Answer: Yes, you can put documents containing PHI into the PRODUCTION environment of eBinders, and it is imperative that you mark those documents as CONTAINING PHI, as that impacts who can view and/or download them. Do NOT put documents containing PHI into the TRAINING environment of eBinders.

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 binder?
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

Question: Does monitor access to eBinders include access to the Central Document binder?
Answer: Yes, and for more on this topic, refer to Florence eBinders: Monitor Account and Access Management.

eBinder Structure Template

Question: I have an idea I would like to share to improve a structure template, how do I share it? 
Answer: Submit a Jira ticket with your idea and the rationale. Your idea will undergo an evaluation at UW and may be submitted to the vendor if it passes that evaluation.

Question: Is there a schedule for structure template updates?
Answer: Yes, structure templates are eligible for updates approximately quarterly, as determined by the vendor.

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 Pharmacy folder within the Subjects folder, when there is already a Drug or Device Accountability Records folder?
Answer: The Pharmacy 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 Pharmacy 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 Pharmacy 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: There is an empty duplicate folder in one of my study binders, how did it get there and what should I do?
Answer: When binder structure backfills occur, folders may be duplicated to recreate the template structure. Backfills may occur when the middleware or binder structure undergo updates. If you see a duplicate folder, ensure you have identified the one that is new (and is empty) and then delete it. If you have questions, submit a Jira ticket.

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 will not display properly.

Question: I uploaded a spreadsheet into eBinders and when I look at the preview, some of the content is missing. What is going on?
Answer: The preview function respects the print settings of the spreadsheet, which includes the print area. The first thing to try if content is missing, is to go into the spreadsheet and clear the print area. This can be done by downloading the spreadsheet, selecting the Page Layout tab, Print Area in the Page Setup group, selecting Clear Print Area, and saving. It is recommended that you preview it prior to uploading it back into eBinders by selecting File, then Print. 

Question: Why is my PDF preview not working correctly?
Answer: Refer to this article from Florence Support for more information (sign-in required).

Additional Resources

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