Guide to the IRB Departmental Reports

Main Audience:  PDA - Primary Department Administrator

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. Click “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 by this icon 
    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.

Contact eBridge
Help Desk

Monday - Friday
8 a.m. to 5 p.m.

414-955-8476

help-ebridge@mcw.edu

Help Desk Tips

To better serve you and to expedite the request process, please have available the following information prior to contacting the Help Desk. You will receive a response to your initial inquiry within four hours (during standard business hours).

SmartForm ID: What is the ID Number?

  • Human Submissions ID (PRO, AME, CPR, RE)
  • Animal Submissions ID (AUA, AA, AR)
  • Funding Proposal ID (FP, BU)
  • IBC Applications ID (IBCYear#)

Location: Where are you in eBridge?

  • Activity
  • Workspace
  • SmartForm
  • Section/Page Number

Problem/Guidance: What were you doing or trying to do?

  • Description of issue
  • What you were doing when the issue occurred
  • Screen shot of error message, if applicable

 

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