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Florence eBinders: Roles and Permissions
- Mapped roles
- How is mapped role defined?
- What is the current status of mapped roles?
- When should users with mapped roles be added to OnCore?
- Where can I go for additional information about the roles in OnCore?
- Who is responsible for user access using mapped roles?
- How do eBinders and OnCore roles, and eBinders training relate for mapped roles?
- What permissions are associated with the mapped eBinders roles?
- How do I properly update a study team member's mapped role?
- Un-mapped (manual) roles
- See Also
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.
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.
When should users with mapped roles be added to OnCore?
Users who are being assigned mapped roles in OnCore must have the correct training type completed and documented prior to being added to OnCore. You can use the UW Florence eBinders Access & Training Documentation Lookup to review which training type has been completed and when.
Note: It is acceptable to exceed the eBinders training requirements noted in this document; however it is unacceptable to have insufficient training. The training types in order from least to most comprehensive are as follows:
- Read Only User (may also be referred to as Basic training)
- View and Sign User (may also be referred to as Investigator or PI training)
- Super User (may also be referred to as eReg user training)
If more advanced training is needed for the role you are giving a user in OnCore, submit an updated single access form request (REDCap).
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.
Who is responsible for user access using mapped roles?
Application support is responsible for creating user accounts after receiving user access requests from study teams and ensuring training has been completed.
Responsibility transfers to study teams when using mapped roles in OnCore. Here is an outline of their responsibilities:
- OnCore users with Protocol or Subject Edit permissions are responsible for the use of mapped roles and must understand when users with mapped roles should be added to OnCore.
- Those being added to mapped roles are responsible for accessing binders only AFTER they have completed the appropriate training.
- Study teams are responsible for addressing monitor, sponsor, FDA inspector, etc. questions about whether adequate training was completed and why users were given specific mapped roles.
- Study teams are responsible for understanding that deleting row entries in the OnCore Staff tab for mapped users does NOT end their access to the study binder, while entering a Stop Date does.
- If someone was given a mapped role in error, you must submit a Jira ticket requesting removal of their access to the binder after you have deleted the row entry from OnCore.
- If someone changes mapped roles, refer to the updating a study team member's mapped role section of this document for more information.
- Study teams are responsible for submitting user deactivation requests through Jira to terminate eBinders access and accounts when applicable.
How do eBinders and OnCore roles, and eBinders training relate for mapped roles?
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
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.
- Refer to the table above, and verify that the current and new roles in OnCore map to the same role in eBinders.
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.
- Refer to the table above, and verify that the current and new roles in OnCore map to different roles in eBinders.
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 start date
- Due to connection setup with OnCore/eBinders, start date must be entered and must be a date AFTER Stop Date for previous role.
- 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.
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, or institutes. 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 following teams have this role:
- UW Health Research Compliance and Billing
- UWCCC Billing Compliance
- CTI and UWCCC Finance
- UWCCC Nurse Navigators
- General View Only + Sign: This role is similar to the one above, and also includes the ability to execute eSignatures. For example, the following teams have this role:
- Pharmaceutical Research Center (PRC)
- Cancer Pharmacology Laboratory (CPL)
- Clinical Research Imaging Core (CRIC)
- 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.