• New account and access requests
• Study binder access request for each monitoring visit
• Physical location of monitors
• Access and permissions overview
• Account deactivation summary

New account and access requests

For monitors who are new to the UW-Madison SMPH instance of Florence eBinders^TM, the request process consists of 2 steps. For returning monitors, refer to the Study binder access request for each monitoring visit section.

Step 1: Request TRAINING

1. If a monitor has completed eBinder training for another institution you must still request training for them so they can attest to completing the UW instance-specific training
2. A monitor-specific training report is available from the UW Florence eBinders Access & Training Documentation Lookup KB page to check if training has been requested for and/or completed by monitor
3. Use the first link ("I need to request eReg TRAINING for a Monitor") on the REDCap survey
4. The requester will be copied on the email that is generated to the monitor
5. The requester will receive an email once the monitor has completed the training

Step 2: Request ACCESS to eReg binder by referring to the instructions in the Study binder access request for each monitoring visit section.

Study binder access request for each monitoring visit

1. Once the monitor has completed the training, use the second link ("I need to request Monitor ACCESS to an eReg Binder") on the REDCap survey
2. Submit access requests at least 1-2 business days prior to the scheduled session to allow time to set up the access
3. The requester will be copied on the email that is generated to the monitor
4. Access can only be granted to an individual monitor for a specific study for one time period, which is typically the duration of the monitoring visit. If that monitor has multiple visits scheduled for the same study, wait until just prior to each visit to request access.
5. A monitor can have access to multiple studies at one time. 
6. If monitor will be working on multiple studies during the same period of time (such as oncology cooperative group auditors), it is acceptable to include multiple study numbers in the same access request. If the visits do not have the same exact monitoring periods, submit separate requests. 

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Physical location of monitors

Monitors do not need to be physically located within the United States (US) to access Florence eBinders; however, this is a requirement for Health Link (HL) access. Because of this discrepancy, study teams would need to print and certify documentation from HL into eBinders for monitoring purposes. Refer to Electronic Certified Copies for more information. 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. 

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Access and permissions overview

The following are included when access is granted to monitors:

• Study-specific binder access
• _Central Documents binder access
• Permission to view study document audit trails, including those for electronic logs (effective for new studies created on or after 12/5/2024)
• Permission to view and download documents from either of the above if they do NOT contain PHI (i.e., if they are NOT marked as containing PHI)
• Permission to view documents in study-specific binders that DO contain PHI (i.e., are marked as containing PHI)
  • Note: This does not apply to the _Central Documents binder as documents containing PHI are not to be filed there as noted in the Florence eBinders: Central Documents eBinder UW User Guide.

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Account deactivation summary

Monitor account deactivation is managed by Application Support because they are able to see whether individual monitor accounts are eligible for deactivation. UW users are NOT responsible for identifying monitor accounts that are eligible for deactivation because they are unable to see whether a monitor they work with also works on other studies. The steps taken to ensure only eligible accounts are deactivated are summarized below.

• User access report is routinely reviewed to identify monitors who have not accessed the UW-Madison SMPH instance of eBinders for over 365 days.
  • If applicable, Application Support reviews all monitor roles assigned to the monitor to ensure each one meets the above threshold.
• Upon confirmation of eligibility, Application Support takes the following actions:
  • Removes monitor account from eBinders
  • Removes monitor name from the monitor-specific training report available from the UW Florence eBinders Access & Training Documentation Lookup KB page
• Note: If a monitor begins monitoring again after account deactivation per the above, users facilitating their visit must follow the New account and access request instructions.

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