Create an Application

1
Create an Application

• jhmeirb_at_jhmi.edu

2
eIRB Accounts

• All users of eIRB must be assigned an account.
• To set up an account in eIRB, select JHED User
  Self Registration or Non JHED User Self
  Registration from the eIRB Login screen at
  http//e-irb.jhmi.edu.

3
Security Certificate

• When using eIRB a security certificate may
  appear.
• You MUST accept the security certificate when
  prompted by eIRB.
• The security certificate is required for
  documents to upload.

4
Security Certificate

• Select Always trust content from this publisher.
• Click Run.
• Other security certificate windows may appear.
• Be sure to ALWAYS trust the content and click
  Run, Go, or OK.

5
JHED Users

• Login to eIRB at http//e-irb.jhmi.edu.
• Login with your JHED ID and JHED password.
• If you forgot your JHED ID or JHED password
• contact JHED directly at jhed_at_jhmi.edu or call
  the JHED IT Support Center at 410-955-HELP.

6
Non JHED Users

• Login to eIRB at http//e-irb.jhmi.edu.
• Non-JHED users login with the username and
  password you received in your email account
  confirmation.
• You will be prompted to change it at your first
  login.
• If you forgot your email address, or the password
  you selected
• email the eIRB Help Desk at jhmeirb_at_jhmi.edu
• we will reset your account.

7
Investigator Home Page

• Blue Title Bar
• My Home returns you to this screen.
• Black Tool Bar
• eIRB Helpdesk
• Step by step instructions and tutorials
• Contact information
• eIRB Survey submits your feedback to the IRB
• Blue Breadcrumb Trail
• Tells where you are in eIRB

8
Investigator Home Page

• Left Navigation Bar
• My IRB Studies
• eIRB Training
• Create a New Application button
• Investigator Tabs
• Lists studies by their current state in the
  submission/review process
• Studies List
• Studies are listed by type

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Investigator Tabs

• Action Required
• Your previously submitted studies awaiting PI
  action
• Researcher Prep
• Your studies that have never been submitted
• In Process
• Your studies awaiting Pre-IRB or IRB action
• Approved
• Your approved studies
• All My IRB Studies
• All your studies in preparation, in process,
  approved, disapproved, expired, terminated, or
  withdrawn

10
Create a New Application

• Select My IRB Studies on the left navigation bar.
• Click the Create a New Application button to
  begin an eIRB application.

11
Application Screen

• Blue Title Bar
• Application number is on the right.
• Light Blue Tool Bar
• Continue
• Saves your work and moves you through the
  application one screen at a time.
• Back
• Does not save. It takes you to the previous
  screen.
• Save
• Saves your work in progress.
• Exit
• Does not save. It returns you to the Application
  Workspace.
• Print
• Allows you to print the current section of the
  application.

12
Hide/Show Errors

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Back
• Save
• Exit
• Print
• Hide/Show Errors
• Click to split the screen, display errors, and
  provide links to screens.
• Click again to hide the split screen.

13
Jump To Drop Menu

• Blue Title Bar
• Light Blue Tool Bar
• Continue
• Back
• Save
• Exit
• Print
• Hide/Show Errors
• Displays errors and provides links to screens.
• Jump To
• Displays list of screens used.
• Use the list to navigate to non-consecutive
  screens.

14
Required Field

• Required
• The red asterisk indicates a required field
  that MUST be completed.
• The PI will not be able to submit the application
  until all required fields have been completed.
• Be sure to enter a title for the study. Never
  leave the title field blank. You need a title to
  access the application.

15
Assign Application Number

• Complete all required fields on the initial
  screen.
• Click Continue to advance to the next screen.
• eIRB will create the application and assign a
  number to it before advancing to the next screen.
• eIRB application numbers begin with NA and may
  be found in the upper right corner of the
  application screens.
• Save will not work until the application number
  is assigned by eIRB.

16
Help Tools

• Help Tools appear beside each question.

17
Help Tools

• Help Tools appear beside each question.
• Regulatory Guidelines
• Click the ? icon to access IRB Regulatory
  Guidelines and Policies.
• Download Forms.
• Information Technology
• Click the i icon to access step by step
  technologic instructions.

18
Drill Down

• Drill down screens look like a multiple document
  upload field.
• Click Add to open screens requiring additional
  information.

19
Drill Down

• Drill down screens look like a multiple document
  upload field.
• Click Add to open screens requiring additional
  information.
• Answer the questions.
• Click OK.

20
Drill Down

• Drill down screens look like a multiple document
  upload field.
• Click Add to open screens requiring additional
  information.
• Answer the questions.
• Click OK.
• Save the screen.

21
Edit Drill Down

• Click Edit to open the screens to upload
  documents, add, or revise information.
• DO NOT click Add and create a new listing to
  upload documents, add, or revise information to a
  pre-existing listing.
• Select the listing and click Delete to remove it.
• Save the screen.

22
Exit the Application

• Click Save to save the screen.
• Click Exit to return to the application workspace.

23
Application Complete

• Application Documents
• Displays all study team documents uploaded into
  the application.
• Documents MAY NOT be uploaded on this screen.
• Documents MAY be downloaded from this screen.
• Click Continue to advance to the last application
  screen.

24
Application Complete

• Click Finish
• This returns you to the Application Workspace.
• Finish indicates the last page of the
  application.
• You may continue to edit the application until it
  is submitted.

25
Application Workspace

• Application Waiting to be Submitted
• Disappears upon submission of the application by
  the PI.
• Study Vital Statistics
• Displays the study name, number, PI, IRB
  Committee, and review type.
• Application Current Status
• Displays the current state of the application in
  the submission/review process.

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Application Workspace

• Review List
• Displays the meeting date, review date, review
  type, outcome, letter, and response.
• Workspace Tabs
• Provide quick access to study-related
  information.
• Will appear as needed.
• History Log
• Reflects completed activities.

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Application Workspace

• Left Navigation Bar
• Divided into three sections.
• View/Print New Application
• View/Edit Application gives access to the
  existing application.
• Printer Friendly View displays a scrollable
  version of the application with the option to
  print.
• Uploaded documents may be opened and printed
  separately from this view.
• View Differences lists changes made to the
  application since the previous submission.

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Application Workspace

• Left Navigation Bar
• Divided into three sections.
• View/Print New Application
• Progress Application Screens
• View Data Entry Progress
• Displays a list of application screens showing
  which are complete, incomplete, or not required.
• Current Activities
• Displays a list of activities that may be
  completed.

29
Application Workspace

• View the Application Current Status box to
  monitor progress through the IRB review process.
• Select View/Edit Application to open an existing
  application.
• View completion Progress on Application Screens.
• Use the Current Activities to request study team
  participation, submit/withdraw the application,
  or submit IND Safety Reports.
• View the History Log to track activities.
• Use the Review List to retrieve the meeting
  outcome letter.

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Application Workspace

• Select My Home and return to the Investigator
  Home Page.

31
Locate an Application

• Select the Researcher Prep tab.
• Scroll down to the New Applications section.
• Select the application name.
• This opens the application workspace.

32
Create an Application

• jhmeirb_at_jhmi.edu