MCW eBridge Human Research Module: Frequently Asked Questions

The Workflow Graphic feature displays in your submission workspaces, providing a high-level summary of the submission's progress towards approval.

1. Locate and navigate to the project (PRO).
2. From the PRO Workspace, select the Amendments tab. All amendments for the project are located under this tab. 
3. Select the withdrawn amendment. 
4. From the Amendment Workspace, select Printer-Friendly Version on the left side to access information within the withdrawn Amendment SmartForm. Navigate to the page to copy information.
5. From the Amendment Workspace, select Printer-Friendly PRO on the left side to access information in the withdrawn copy of the PRO SmartForm. Navigate to the page to copy information.

The Principal Investigator (PI) can be changed via an Amendment (AME). Any person listed on the Project Team with edit access can open an amendment.

1. From the PRO Workspace, click  Open New Amendment and complete the AME SmartForm.
2. From the Amendment Workspace, click View/Edit PRO SmartForm. 
3. Change the Principal Investigator in Section 1.
4. Update the existing responses in Section 1 so that they are relevant to the new PI.
5. Select Save.
6. Select Exit.
7. The new PI  and the current PI will now have the Submit Application activity to submit the AME for review.

• During the AME review process, the new PI will not have access to the Approved PRO workspace.
• Once the AME is approved, the new PI will be listed in the PRO SmartForm and gain access to the activities in the PRO Workspace.

Funding sources managed within eBridge can be selected within the PRO SmartForm to identify support for the project activities. This link is created in “real-time” and is displayed within both the PRO SmartForm and the selected Budget SmartForm.

 A Funding Proposal/Budget will display to be selected from the list within the PRO SmartForm if any of the following is true:

• The PI on the PRO is the PI on the Funding Proposal.
• The PI on the PRO is Key Personnel on the Funding Proposal
• The PI on the Funding Proposal is a Project Team Member on the PRO. 

To create a link:

• The Project Team Member or the PI must have the Budget ID, the FP ID, or the name of the Funding Proposal (FP) available.
• The Project Team Member or the PI performing the linking must have edit access to the PRO.
• The PRO must be in an editable state, such as Pre-submission or Changes Requested. If the PRO is in an Approved state, a new Amendment must be created.
  • A Funding Proposal/Budget can be linked to while the FP is in any state. 

Linking from a new PRO

(PRO state is either PreSubmission or Changes Requested…)

1. Locate and navigate to the PRO Workspace.
2. Select Edit PRO SmartForm on the left side of the Workspace to access the PRO SmartForm.
   • Note: If “View PRO SmartForm” is displayed on the left side, this means that the SmartForm is not in an editable state during the review. Please contact the IRB Coordinator listed in the PRO Workspace who can request changes to route the PRO to you so that the SmartForm is editable.
3. In the PRO SmartForm, navigate to Section 11. Funding Source.
4. From Question 11.1.2, select Add. A new pop-up screen appears.
5. From Section A: click the ellipses (…) next to Budget in eBridge. A new pop-up screen appears.
6. Use Filter by Budget ID to search for the budget.
7. Select the radio button for the Budget from the list provided.
8. Select  OK.
9. Confirm that you see the selected Budget ID displayed in Budget in eBridge.
10. Select OK at the bottom of the screen.
11. Select Save and Exit from the PRO SmartForm. This returns you to the PRO Workspace. 

Linking from a PRO that has been Approved, Registered or Processed Relying on an External IRB

1. Locate and navigate to the PRO Workspace.
2. Select Open New Amendment from the left side.
3. Complete the Amendment SmartForm.  
4. Save and Exit to the Amendment Workspace.
5. Select View/Edit PRO SmartForm from the left side of the AME Workspace.
   • Note: a copy of the PRO SmartForm is created with an amendment.  This may take a few minutes.  If ‘View/Edit PRO SmartForm’ text is not available, then the copying is still in progress.  The text will be available when the copying has completed. You will need to refresh the browser after 1-2 minutes.
6. In the PRO SmartForm, navigate to Section 11. Funding Source.
7. From Question 11.1.2, select Add. A new pop-up screen appears. 
8. From Section A: click the ellipses (…) next to Budget in eBridge. A new pop-up screen appears.
9. Use Filter by Budget ID to search for the budget.
10. Select the radio button for the Budget from the list provided.
11. Select OK.
12. Confirm that you see the selected Budget ID displayed in Budget in eBridge.
13. Select OK at the bottom of the screen.
14. Select Save and Exit from the PRO SmartForm. This returns you to the Amendment Workspace.
15. From the Amendment workspace, the PI will need to select Submit Application. 
    

Related FAQ

Who has edit access to the PRO?

• Project Team Members with edit access will be listed in the PRO SmartForm, Section 2.1.
• The Principal Investigator of the PRO (does not need to be listed in Section 2.1)

How do I determine if a PRO is editable?

A PRO is editable by the PI or Project Team Members listed in Section 2 with edit access if:

• The PRO is in the state of Pre-Submission. The PRO will be displayed on the Research Submissions tab of the Dashboard.

OR

• If changes have been requested during the review. The PRO will be displayed in PI/Project Team Member’s Action Required tab of the Dashboard. The state will begin with “Changes...”.

Where do I find the Budget ID?

The Budget ID is located within the Funding Proposal Workspace labeled Primary Budget ID.

• If you have access to the Funding Proposal, then the Budget ID can be found in the Summary area of the Funding Proposal Workspace. Example: Primary Budget ID: BU00000068. Make a note of the Budget ID/Number (NOT the Funding Proposal ID).
  • Note: The Budget ID can also be found under the Budgets tab of the Funding Proposal Workspace. However, there may be more than one budget and you will need to select the Awarded Budget. It is simpler to use the Primary Budget ID in the Workspace.
• If you do not have access to the Funding Proposal/Budget, ask the PI or Department Administrator to provide the Budget ID to you.

Removing a link from a new PRO

• The Project Team Member or the PI removing the linking must have edit access to the PRO.
• The PRO must be in an editable state, such as Pre-submission or Changes Requested.

1. Locate and navigate to the PRO
2. Select Edit PRO SmartForm in the left side of the Workspace to access the PRO SmartForm.
   • Note: If View PRO SmartForm is displayed on the left instead, then this means that the SmartForm is not in an editable state during the review. Please contact the IRB Coordinator listed in the PRO Workspace who can request changes to route the PRO to you so that the SmartForm is editable.
3. In the PRO SmartForm, navigate to Section 11. Funding Source.
4. In question 11.1.2, click the X to remove the link.
5. Select OK to confirm deletion. 
6. Select Save to save the SmartForm page.
7. Select Exit to return to the PRO Workspace. 

Removing a link from a PRO that is Approved, Registered or Processed Relying on an External IRB

• The Project Team Member or the PI removing the linking must have edit access. 
• The Amendment must be in an editable state, such as Pre-Submission or Changes Requested.

1. Select Open New Amendment from the left side of the PRO Workspace.
2. Complete the Amendment SmartForm.
3. Save and Exit to the Amendment Workspace.
4. Select View/Edit PRO SmartForm from the left side of the AME Workspace.
   •  Note: a copy of the PRO SmartForm is created with an amendment. This may take a few minutes. If View/Edit PRO SmartForm text is not available, then the copying is still in progress. The text will be available when the copying has completed. You will need to refresh the browser after 1-2 minutes.
5. In the copy of the PRO SmartForm, navigate to Section 11. Funding Source.
6.  In question 11.1.2, click the X to remove the link.
7.  Select OK to confirm the deletion.
8.  Select Save to save the SmartForm page.
9.  Select Exit to return to the Amendment Workspace.
10. From the Amendment Workspace, the PI will need to select Submit Application. 

The Update My Project activity is available to make the following types of changes on an approved PRO:

• Add/Remove Project Team Members
• Update the Primary Contact
• Update a Project Team Member’s role, MRI Involvement, EPIC access, Human Source Material Involvement, Significant Financial Interest, edit access, permission to receive eBridge emails
• Add or correct the ClinicalTrials.gov number for the project
• Update the phone/page number (not applicable for all project types)
• Update the project end date (not applicable for all project types)
  

Any new human subjects research projects (PRO) will be routed to a representative from the Principal Investigator’s department. The department review will occur after the new PRO is submitted and before the new PRO is received by the IRB Office.

A department review is not required on Amendments, Continuing Progress Reports or Reportable Events.

The submission activity includes a PI Attestation that only the Principal Investigator is required to complete.

After initial submission, if the project requires changes, anyone on the project team with edit access can make and submit the changes.

Human Subject Research (HSR) training is required for the PI, all Key Personnel and Project Staff on a PRO Project Team.

• “Non-research clerical staff” can be added to the PRO Project Team, but are not required to complete Human Subject Research training. 

eBridge verifies the HSR (CITI) training recorded on a person’s Researcher Profile. Each individual listed on the study as PI, Key Personnel or Project Staff should:

• Have their CITI ID documented on their eBridge account.
• Be affiliated with MCW within the CITI system to ensure that the person’s training records are automatically added into eBridge from CITI.

More information about CITI training can be found on the HRPP website.

1. Login to eBridge.
2. From your Dashboard, click on View My Researcher Profile under Activities on the left side of the screen. This brings you to your Researcher Profile workspace.
3. On the left side of your Researcher Profile Workspace, click Print Training Profile. 
4. In the upper right of the screen, click Print to print all training documented in eBridge to a PDF.

eBridge has several roles that help Medical College of Wisconsin (MCW) departments monitor and track training required for study teams involved in research.

Roles include:
• Safety Training Administrator
• Human Research Training Administrator
• Compliance Training Administrator

Features:
• These roles can be assigned to multiple people in a department.
• Training Administrators receive notifications about expiring training for all people in their department for safety, human subject research, and compliance (the FCOI-R required training).
• Training Administrators can read or export reports.

If you have one of the above training administrator roles, you can access and run training reports for your department. To access the reports for each training administration area:

1. Log in to eBridge.
2. Click on the Dashboard tab at the top left.
3. Select the Reports tab.
4. This tab will display all reports to which you have access.
5. Click on the specific report you are interested in running.

The (ADR) administrative department representative, department chair or division chief can request any or all the training administrator roles to be added to someone’s account from their department using the Authorized User Update Form. 

Main Audience:  ADR - Authorized Department Representative

Instructions

Accessing the Reports:

1. Log into eBridge.
2. Go to the Reports tab on the Dashboard.
3. Under the Departmental Reports Section, click Human Subject Research Reports.
4. Select either:
   1. IRB Protocols for Department – Approved
   2. IRB Protocols for Department – Presubmission
   3. IRB Protocols for Department – Expiring or Expired Protocols
5. In the top area, there are drop-down menus that enable you to tailor the information you wish to access.
   1. Select the Department or Departments (if you are PDA for multiple departments).
   2. Select the Division(s) (if you wish to focus the report). The default is to include all Divisions within the Department.
   3. Select the time period you would like to access data for by using the Start and End Dates.
      1. The default start date is 12/31/2005 (you can adjust this back for projects approved prior to 2005)
      2. The default end date is today
6. Select View Report on the far right of the screen.
7. Once the data appears on your screen, you have the option to review it there or export it to Excel
8. To export to Excel
   1. Click the down arrow in the top right.  
   2. Select Excel.
   3. Select Open in the File Download pop-up window.

 

Interpreting the Reports:

The report displays the following information for each PRO in the various reports that were selected. Please note that not all the fields are present in each report:

• IRB ID = PRO ID #, e.g., PRO00000001
• IRB Title = Title of the PRO
• Status = State of the PRO (i.e., Approved, Expired, or Presubmission)
• PI Last Name
• PI First Name
• Division = PI’s division within the department
• Department = PI’s department
• Review Type = Identifies the type of review that project received (Full IRB review, Expedited, Exempt)
• Committee = Identifies which IRB Committee has reviewed the project (#1-4 & 8 are greater than minimal risk Committees and #5 & 7 are minimal risk)
• Date Originally Approved Date = date that the PRO was originally approved by the IRB
• Approved Date = the most recent approval date from the IRB (or re-approval date) 
• Expiration Date = the date by which the next Continuing Progress Report (CPRs) must be approved by the IRB. CPRs should be submitted approximately 60 days before this date to have the best chance of being approved in time to prevent expiration.
• Project Type = category that best describes the type of research project.
• Project Descriptors = Identifies key components of a project.
• Study Type = Pulls information from question 3.2 in the PRO SmartForm. Typically provides additional aspects about a project, and may contain some carryover data from SmartForm V1
• Funding Source = Indicates whether a project is receiving funding (Yes or No)
• FP ID = Identifies the FP# linked to the project
• FP Type = Categorizes the type of funding
• Intervention = Indicates if the project involves an intervention (Yes or No)
• FDA Phase = Identifies the phase of the study (I, II, III, IV)
• Drug/Device/Biologic = Indicates if the project contains an FDA regulated Drug, Device or Biologic
• MCW Coord Center = Indicates if MCW is serving as the Coordinating Center for the project
• Ancillary Review = Indicates which additional institutional reviews are required with this project
• Safety Review = Indicates which safety reviews are required with this project
• Contribute to Banks – ID = This is only for projects which indicate they contribute to an IRB approved bank. The PRO ID number displayed here is for a bank.
• Contribute to Banks – Title = The title of the identified bank that the project is contributing data or specimens. 
• Access Banks – ID = This is only for projects which indicate they are accessing an IRB approved bank. The PRO ID number displayed here is for a bank.
• Access Banks – Title = The title of the identified bank that the project is accessing data or specimens.

No. A research project can access or contribute to multiple banks. Likewise, a bank may allow access for multiple projects as well as receive contributions from multiple projects and other banks.

View Differences will show changes made to the SmartForm.

1. These changes can be viewed by selecting, View Differences in the workspace. Locate View Differences under the State in the upper left of the workspace.
2. This will open the SmartForm.
3. Compare is selected in the upper left corner of the Navigation Panel.
4. Select the version you want to compare to the most current changes. The version selected will be compared to the most recently edited version of the application.
5. The sections with the pencil icon in the left navigation pane will indicate which sections have been changed.
6. Select Section titles with a pencil icon to navigate to different sections of the SmartForm. 
7. Use the color coding and strikethrough features to identify the modifications:
   Text in green = added text
   Text in red = original text
   Text with strikethrough = deleted text
8. To exit Compare Mode, select the Menu button in the Navigation Panel.    

You can also access Compare mode within the SmartForm at any time, by selecting Compare in the upper left of the Navigation Panel.