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Research Systems

Human Research Module: Frequently Asked Questions

Human research applications, or Protocols, are overseen by the Institutional Review Board (IRB) of the Human Research Protection Program. 

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Accessing information from a withdrawn amendment
  1. Locate and open the project. From the Study Workspace, select the Amendments tab. All amendments for the study are located under this tab. Select the withdrawn amendment. From the Amendment Workspace, and from the left column, select the Printer-Friendly Version button below the View Amendment button to copy and paste desired information into the new Amendment SmartForm.
  2. Information from the modified study of the withdrawn amendment can be copied and pasted into the modified study of the new amendment by selecting the Printer-Friendly Study button below View Study History.
How can get a transcript of my research training in eBridge?

 

  1. Login to http://ebridge.mcw.edu
  2. From your Dashboard, click on the Activity View My Researcher Profile. This will take you to your Researcher Profile Workspace.
  3. On the left side of the screen, click the link called “Print-Friendly Profile.” 
  4. The next screen will display a list of all training documented in eBridge.
  5. In the upper right of the screen, click the Print button for a hard copy, or print to PDF.
Changing the PI on a human research project

If the PI is no longer employed at MCW, have one of the Project Team Members listed on the PRO with edit access open an amendment. 

  1. Use the View/Edit Modified Study in the AME Workspace.
  2. Change the PI in question 1.3. Select Save and Exit the SmartForm.
  3. The new PI will now have the activity to submit the AME.
  • Once the AME is approved, the new PI is listed in the PRO. During the approval process the new PI will not be able to edit the study.
  • Once the AME is approved, the new PI is listed in the PRO. During the approval process the new PI will not be able to edit the study.
PRO Workflow Graphics

With the 3/23/19 eBridge Update, the Workflow Graphics feature will now display in your submission-specific workspaces, providing high-level visualizations of your progress towards approval or activation.

IRB-graphic

How can I track Department Training ?

Departmental Training Reports

Main Audience: Human Research Training Administrators (assigned per department)

Tracking Training for your Department in eBridge (PDF)

Does bank status matter in order for contributions or access?
No, a bank can be selected in eBridge in any state. However, new entries under the tabs Contributing to Bank and Accessing the Bank will not appear until the bank is in an Approved state. (Note: the availability of the tabs is dependent upon the banking project version as well.)
IRB Departmental Reports

IRB Departmental Reports

Main Audience:  ADR - Authorized Department Representative

Instructions

Accessing the Reports:

  1. Log in to eBridge.
  2. Go to the My Department Reports tab on the PDA Home Page.
  3. Under the IRB Section, click Report.
  4. Select either:
    1. IRB Protocols – Approved
    2. IRB Protocols – Presubmission
    3. IRB Protocols – Expiring or Expire
  5. In the top area, there are three 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.  
    2. Select Excel.
    3. Select Open in the File Download popup 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 are full Committees and #5 is 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 in order to have the best chance of being approved in time to prevent expiration.
  • Project Type = Clearly identifies a project as one of the following:
    • Research Study,
    • Research Study + Distant Bank,
    • Research Study + Local Bank,
    • Local Bank,
    • Treatment Use,
    • Emergency Use
    • NCI-CIRB (available once NCI-CIRB review process is approved)
  • Project Descriptors = Identifies key components of a project.  Descriptors are the following:
    • Community
    • Deceased
    • Expedited/Exempt
    • FDA IND
    • FDA IDE
    • FDA Biologic
    • FDA Other
    • International
    • Intervention
    • Lab Work
    • Multi-Site
    • Planned Emergency
  • Study Type = Pulls information from question 4.1 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 = Identifies the type of Funding Proposal
    • Federal,
    • Federal Pass-Through,
    • For Profit,
    • Internal,
    • Local,
    • Non-Profit,
      State
  • Intervention = Pulls from question 3.1.2 in the PRO SmartForm to indicate if the project involves an intervention (Yes or No)
  • FDA Phase = Pulls from question 4.2 in the PRO SmartForm, and 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 = The PRO ID number of a bank. This is only for projects which indicate they contribute to a MCW/FH IRB approved bank.
  • Contribute to Banks – Title = The title of the identified bank (Contribute to Bank – ID), the project is contributing data or specimens. 
  • Access Banks – ID = The PRO ID number of a bank. This is only for projects which indicate they are accessing a MCW/FH IRB approved bank.
  • Access Banks – Title = The title of the identified bank (Access Banks – ID), the project is accessing or obtaining data or specimens.
Is there a one-to-one relationship between a bank and a project?
No. A 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.
Linking a Protocol to a Funding Proposal

Main Audience: Principal Investigators, Proposal Team, Study Staff

When linking a Human Research Protocol (PRO) to a Funding Proposal (Grants & Contracts) budget within eBridge, you are identifying a funding source for your research. The actual linking in eBridge occurs within the PRO SmartForm and is a “real-time” connection. There are two sections to this document:

I. Step-by-Step Instructions
    Linking when in an editable state
    Linking when in a non-editable state
    Unlinking when in an editable state
    Unlinking when in a non-editable state

II. Conditions necessary to perform the linking
    What Budgets will be available to me when I perform the Linking/Unlinking activity?
    How do I determine the State of a PRO and if it is editable?
    How do I see who has Edit access to the PRO?

I. Step-by-Step Instructions

Linking a PRO to a Budget

If the PRO is in "Pre-submission" or "Changes Requested by..."

  1. Locate the Funding Proposal Budget ID
    1. If you do not have access to the Funding Proposal Budget, ask your PI or Department Administrator to find the Budget ID/Number for you.
    2. If you do have the Proposal Team role and at least View access, log in to eBridge and navigate to My Home (your Personal Workspace).
    3. From My Home Select the Proposal Team Role in the upper left area of the screen.
    4. Search for the Funding Proposal ID using the Filter by field, select the link and go to its Workspace. The budget link is located in the lower area of the Funding Proposal Workspace under the Budgets tab. Its ID/Number is to the left of its name (e.g. BU00000068). There may be more than one budget. As noted in the screen shot below, choose only the Budgets or the Budget Under ReconciliationMake a note of the Budget ID/Number (NOT the Funding Proposal ID). 



  2. Switch to the Study Staff Dashboard
  3. Select the PRO from the Pre Submission or the Action Required tab.
  4. Select the Edit Study button in the upper left area of the Workspace. This button is only available when the PRO is in an editable state. When the PRO is in the Approved state, you need to create and submit an Amendment to complete the linking. (see instructions below)
  5. Use the Jump To menu and go to Section 11, Funding Source.
  6. From Question 11.1.2 select Add. A pop-up screen appears. 
  7. From Section A choose Select. In the Filter by select Budget ID. In the search field, type the % character as a wild card, then the Budget ID/Number you jotted down in Step 1.D, using the format %43. Select Go.
  8. When the results appear, check the radio button next to the one you noted and select OK. If you do not find the Budget you need, make sure the Conditions are met.
  9. Select Save and Exit from the PRO SmartForm. This returns you to the PRO Workspace.
  10. The link will also appear in the "Funding Proposal Workspace" under the Project Information Links in the center area of the screen. Select Link from Grant to IACUC/IRB Status. It is also viewable from the Budget SmartForm Page U, Question 4.0.

If the PRO is in the state of Approved 

  1. Complete steps 1 - 3 above.
  2. Select the PRO from the Human Projects tab to go to the PRO Workspace.
  3. Select the activity Open New Amendment.
  4. Complete the Amendment SmartForm.  Save and Exit to the Amendment Workspace.
  5. The PRO will begin the copying process - this may take a few minutes.
  6. When copying is complete, select View/Edit Study.
  7. Complete steps 6 - 11 above.
  8. From the Amendment workspace, select Submit to IRB

Unlinking a PRO from a Budget

If the PRO is in Pre-submission or Changes Requested

  1. Go to the PRO SmartForm, Section 11, Question 11.1.2
  2. Click on the Delete button to remove the link. Click OK.  (see screen shot below)
  3. Click the Save button.
  4. Click Exit to return to the PRO Workspace.
  5. Check that the PRO is removed from the Budget by reviewing the Project Information Links in the "Funding Proposal Workspace."

If the PRO is in the state of Approved 

  1. Select the activity Open New Amendment from the PRO Workspace.
  2. Complete the Amendment SmartForm, Save and Exit to the Amendment Workspace.
  3. The PRO will begin the 'Copying' process - this may take a few minutes.
  4. When 'Copying' is complete, select View/Edit Study.
  5. Follow the steps 1 - 5 above.
  6. From the Amendment Workspace, select Submit to IRB

II. Conditions for Creating a Link to a Budget of a Funding Proposal

  • The PRO must be in an editable State, such as Pre-submission or Changes RequestedIf the PRO is in an approved State, an Amendment must be created. 
  • A Funding Proposal can be linked while in any state.
  • The Study Staff or the PI performing the linking must have edit access to the PRO. 

A. What Budgets will be available to me when I perform the Linking/Unlinking activity?

The Study Staff and PI will see a Funding Proposal budget in the list if either of the following is true:

  1. The PI on the PRO is the PI or Key Personnel on the Funding Proposal.
  2. The PI on the Funding Proposal is a Study Staff on the PRO.

B. How do I determine the "State" of a PRO and if it is editable?

A PRO is editable by the PI or Study Staff if:

  • It is in the State of Pre-submission.

OR

  • If changes have been requested during the Workflow and the PRO is back in your Action Required tab.

If you see Printer Friendly Version you will have to wait until either the Workflow brings it back to your Action Required tab for changes, or, if Approved, you will have to open an Amendment to edit the PRO and complete the linking. 

C. How do I see who has Edit access to the PRO?

  • Those with Edit access will be listed in the PRO SmartForm, Section 2.1.

 

Using Hide Show Errors to Check for SmartForm Errors

Using Hide/Show Errors

Main Audience: All eBridge Users

Before the Principal Investigator submits the funding proposal in eBridge for institutional approvals, the Funding Proposal, Primary Budget, Detailed Subcontract and SF424 SmartForms should be verified and corrected for errors.

Roles:  Principal Investigator (PI), Proposal Team (PT), Budget Specialist (BS)

Steps:

  1. After logging in to eBridge 
  2. Make sure the Proposal Team Dashboard is selected.
  3. Select the Funding Proposal Name from My Inbox or Funding Proposals tab.

From the Funding Proposal SmartForm:

  1. From the "Funding Proposal Workspace", select the Edit Funding Proposal button from top-left corner to navigate to the Funding Proposal SmartForm.
  2. From the middle menu at the top or bottom of the screen, select Hide/Show Errors. Note any errors in the lower section of the page.
  3. For each error, select the associated Jump To link and make the appropriate corrections.
  4. To remove the corrected error from the Error/Warning Messages section, select Save in the Jump To menu & then select the Refresh button on the right side of the Error/Warning Messages section.
  5. When all errors are corrected, select Exit and Save.

From the Budget SmartForm:

  1. From the Funding Proposal Workspace, scroll down, and from the Budgets tab, select the SmartForm [Open] drop-down menu and select T. Budget General to navigate to the first page of the Budget SmartForm.
  2. From the middle menu at the top or bottom of the screen, select Hide/Show Errors. Note any errors in the lower section of the page.
  3. For each error, select the associated Jump To link and make the appropriate corrections.
  4. To remove the corrected error from the Error/Warning Messages section, select Save in the Jump To menu & then select the Refresh button on the right side of the Error/Warning Messages section.
  5. When all errors are corrected, select Exit and Save.

From the Detailed Subcontracts SmartForm (if applicable):

  1. From the Funding Proposal Workspace, scroll down, and from the Budgets tab, select the budget's Name link to navigate to the Budget Workspace.
  2. Select the Subcontracts tab.
  3. At the bottom of the Subcontracts tab, select each subcontractor's Name link.
  4. From each Subcontract Workspace, select the Edit Subcontract Budget button from the left column to navigate to the Subcontract SmartForm.
  5. From the middle menu at the top or bottom of the screen, select Hide/Show Errors. Note any errors in the lower section of the page.
  6. For each error, select the associated Jump To link and make the appropriate corrections.
  7. To remove the corrected error from the Error/Warning Messages section, select Save in the Jump To menu and then select the Refresh button on the right side of the Error/Warning Messages section.
  8. When all errors are corrected, select Exit and Save.

 From the SF424 SmartForm (if applicable):

  1. Generate a SF424, if not already done, by selecting the View SF424 link from the left column in the Funding Proposal Workspace. Select OK.
  2. In the middle of the Funding Proposal Workspace, from the Submissions to Sponsor section, select the [Open] drop-down menu, and select the first page to navigate to the SF424 SmartForm. 
  3. From the middle menu at the top or bottom of the screen, select Hide/Show Errors. Note any errors in the lower section of the page.
  4. Extend the Error/Warning Messages section from the top to view the entire Error/Warning Message section. 
  5. Using the Alt + Print/Screen keys on your keyboard, print the page.
  6. Go back to the Funding Proposal SmartForm and/or Budget SmartForm to make the appropriate corrections.
  7. Re-generate the SF424 application by selecting the View SF424 link from the left column.
  8. Confirm that all errors were corrected by following Steps #2 - #3 above. If not all errors are corrected, continue following the remaining steps above, #4 - #7.
What is a bank?
A bank is a collection of data, information, and/or different types of bio specimens, in which the contributing subjects have consented to future unspecified research so that the bank contents can be used without re-consenting subjects.
What is the difference between a local and distant bank?

The terms local and distant refer to control of the bank rather than geographic location. Local banks are under the supervision of the MCW IRB, and managed by an MCW PI, regardless of their geographic location. Distant banks are not under the control and supervision of MCW. 

 
When can I use the Update My Approved Study activity
You can use the Update My Approved Study activity in an approved protocol to make changes to the Project Team Members listed in Section 2 of the Study SmartForm. You can also use this activity to update the phone/pager number. This activity is available regardless of whether an amendment or conversion CPR is open, and either the Principal Investigator (PI) or a project team member with edit access can use it. Some changes are automatically made in the SmartForm and other changes are routed for IRB Staff Review.
Who can access an existing bank?
The PI in charge of the bank defines who has access by filing bank policies and procedures with the IRB. To access a bank a researcher needs to have the permission of the bank’s PI, as well as MCW IRB approval. If a PI wishes to change the criteria for those allowed access to the bank, an Amendment to the Banking Protocol will need to be submitted.
Why does the department have to review new studies?
The department has to review new studies to attest that the faculty member submitting the research project is in good standing, and that the department is willing to commit the resources necessary for conducting the research.
Why is the PI the ONLY one who can submit?
The PI has to submit initially because he/she must attest to the project's accuracy. The PI is personally responsible for the project and all its related activities. After the initial submission, if the project requires changes, anyone on the study team (with edit access) may resubmit following editing.