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Florence eBinders: Roles and Permissions

This document contains information about the Florence eBindersTM roles and permissions.

Mapped roles

How is mapped role defined?

Mapped roles are eBinder roles that are associated with (also known as mapped from) the roles assigned to users within our Clinical Trials Management System (CTMS) called OnCore.

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What is the current status of mapped roles?

The main mapped roles were established during the initial implementation of eBinders. As more departments, centers, institutes, and research groups start using eBinders, we are developing additional roles, some of which may be mapped from OnCore. We will continue to update applicable eBinders resources as these roles are developed.

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Where can I go for additional information about the roles in OnCore?

For more information about roles in OnCore, visit OnCore: Protocol Roles. Roles in OnCore that are not included in the table below (middle column) are not currently mapped.

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How do eBinders and OnCore roles, and eBinders training relate for mapped roles?

The table below shows which eBinders role (first column on left) a user will be assigned based on their OnCore role (middle column). It also shows which eBinders training type is needed based on the roles (minimum requirement) (last column from left).
eBinders Roles Mapped OnCore Roles eBinders Training Type Requirement
Study Coordinator
  • Study Coordinator
  • Primary Study Coordinator
  • Research Nurse
  • Data Coordinator
  • Protocol Administrative Coordinator
  • Data Manager
  • Program Manager
 Super User (may also be referred to as eReg user training)
Regulatory Staff
  • Regulatory Coordinator
  • Primary Regulatory Coordinator
  • Protocol Coordinator
  • Multi-site Coordinator
  • Research Administrator
 Super User (may also be referred to as eReg User training)
Study Investigator
  • Principal Investigator
  • Sub-Investigator
  • Co-Investigator
  • Fellow/Trainee
  • Statistician
  • Treating Physician
 View and Sign User (may also be referred to as Investigator or PI training)
Internal Compliance/DSMC Coordinator
  • Compliance and Monitoring Coordinator
 Read Only User (may also be referred to as Basic training)

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What permissions are associated with the mapped eBinders roles?

Study Coordinator

Study-specific binder permissions summary:

    • Create, duplicate, rename, and move folders
    • Upload/download, replace, move, duplicate, and delete documents with and without PHI
    • Sign and annotate (e.g., add text, highlight, redact) documents
    • Manage due dates and expiration dates on documents
    • Fill and finalize forms
    • Create, edit, sign, strikethrough row entries, and delete elogs
    • Request signatures from others on documents and elogs
    • Mark/unmark PHI
    • Assign tags, create shortcuts, and fill placeholders
    • View and download audit trails

Central Documents binder permissions summary:

    • Same as above, except things related to PHI, as there should not be any PHI in this binder
Regulatory Staff

Study-specific binder permissions summary:

    • Create, duplicate, rename, and move folders
    • Upload/download, replace, move, duplicate, and delete documents with and without PHI
    • Sign and annotate (e.g., add text, highlight, redact) documents
    • Manage due dates and expiration dates on documents
    • Assign document types
    • Fill and finalize forms
    • Create, edit, sign, strikethrough row entries, and delete elogs
    • Request signatures from others on documents and elogs
    • Mark/unmark PHI
    • Assign tags, create shortcuts, and fill placeholders
    • View and download audit trails

Central Documents binder permissions summary:

    • Same as above, except things related to PHI, as there should not be any PHI in this binder
Study Investigator

Study-specific binder permissions summary:

    • Sign, annotate (e.g., add text, highlight, redact), and download documents with and without PHI
    • Fill and finalize forms
    • View audit trails
    • Sign elogs

Central Documents binder permissions summary:

    • Sign, annotate (e.g., add text, highlight, redact), and download documents without PHI
Internal Compliance/DSMC Coordinator

Study-specific binder permissions summary:

    • View and download documents with and without PHI
    • View and download audit trails

Central Documents binder permissions summary:

    • View and download documents without PHI

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How do I properly update a study team member's mapped role?

The instructions below include role mapping and training verification, and how to update the OnCore Staff tab.

OnCore roles that map to the SAME eBinders role (e.g., sub-investigator and principal investigator)

Role verification:

    • Refer to the table above, and verify that the current and new roles in OnCore map to the same role in eBinders.
      • For example, if a sub-investigator is taking over as principal investigator, both of these OnCore roles map to the Study Investigator role in eBinders.
    • If they map to the same eBinders role, continue to the next step. If they do not, go to the OnCore roles that map to different eBinders roles collapsing panel.

Training verification:

    • Refer to the table above, and verify that the current and new roles require the same training type for eBinders.
    • Refer to the eBinders training lookup to ensure the individual meets or exceeds the training requirement.
    • If the training requirement is met, continue to the next step. If not, submit a change in access request to have the individual complete the required training.

Updating OnCore Staff tab:

    • In the OnCore Staff tab, select the Update button.
    • Navigate to the current row entry for the applicable individual and select the Edit hyperlink in the Edit column.
    • In the pop-up window, change the current role to the new role. Do not enter a Stop Date.
    • Select the Submit button.
    • Verify the individual's role updated properly, then select the Close button on the Staff tab.
OnCore roles that map to DIFFERENT eBinders roles (e.g., data coordinator and regulatory coordinator)

Role verification:

    • Refer to the table above, and verify that the current and new roles in OnCore map to different roles in eBinders.
      • For example, if a data coordinator is becoming a regulatory coordinator, these OnCore roles map to different role in eBinders (Study Coordinator and Regulatory Staff, respectively).
    • If they map to different eBinders roles, continue to the next step. If they map to the same roles, go to the OnCore roles that map to the same eBinders role collapsing panel.

Training verification:

    • Refer to the table above, and verify whether the training type requirement for the current and new roles is the same for eBinders.
    • Refer to the eBinders training lookup to ensure the individual meets or exceeds the training requirement for the new role.
    • If the training requirement is met, continue to the next step. If not, submit a change in access request to have the individual complete the required training.

Updating OnCore Staff tab:

    • In the OnCore Staff tab, select the Update button.
    • Navigate to the current row entry for the applicable individual and select the Edit hyperlink in the Edit column.
    • In the pop-up window, enter the Stop Date.
    • Select the Submit button (this is what terminates their current role in eBinders).
    • At the top of the Staff tab, enter their new role, their name, and their (optional) start date.
    • Select the Add button (this is what gives them their new role in eBinders).
    • Verify the new role entry saved properly, then select the Close button on the Staff tab.

Deviations from above process:

    • If deviations from the above process are discovered during routine eBinders access quality control activities, the applicable parties are notified and are responsible for making corrections within the communicated timeframe (approximately one (1) week) or risk loss of access to eBinders.

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Un-mapped (manual) roles

In addition to the mapped roles above, there are several roles in eBinders that are NOT associated with OnCore. These roles are referred to as un-mapped or manual roles. Other than monitors, they are NOT assigned to specific studies because they are intended to serve users who access studies across many or all departments, centers, institutes, or research groups. Here are some examples of these roles:

  • Monitor: More information is available here: Florence eBinders: Monitor Account and Access Management.
  • Note: To lookup whether a UW user already has an active eBinders account, you can use this lookup tool.
  • General View Only: This role is assigned to users who need to access non-PHI containing study documents like protocols, IRB approvals, and manuals. For example, the UW Health Research Compliance and Billing team has this role.
  • General View Only + Sign: This role is similar to the one above, and also includes the ability to execute eSignatures. For example, the Pharmaceutical Research Center (PRC) has this role.
  • Team Administrator: This role is for those serving in an administrator role for the University of Wisconsin instance of eBinders, such as the application support team.

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See Also


Keywords:
permission, table, OnCore, mapped, map, eReg, training, needed, unmapped, unmap 
Doc ID:
119475
Owned by:
Jill K. in SMPH Research Informatics
Created:
2022-07-08
Updated:
2024-11-07
Sites:
SMPH Research Informatics , SMPH Research Informatics TEST