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JHMeIRB. eIRB 101: Prepare and Submit an eIRB Application. Topics. Accounts and Websites Investigator Home Screen Application Workspace Application Screens Study Proposal Consent Form Application Complete Respond to Reviewer Notes Create a Further Study Action.

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eIRB 101: Prepare and Submit an eIRB Application


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topics
Topics
  • Accounts and Websites
  • Investigator Home Screen
  • Application Workspace
  • Application Screens
  • Study Proposal
  • Consent Form
  • Application Complete
  • Respond to Reviewer Notes
  • Create a Further Study Action
irb website http www hopkinsmedicine org institutional review board
IRB Website http://www.hopkinsmedicine.org/institutional_review_board
compliance training
Compliance Training
  • All compliance training courses are available online through the Hopkins myLearning website.
  • Be sure to save and print your certificates at the time you complete each course.
technical training
Technical Training
  • eIRB Tutorials and Registration for Upcoming Training
  • Must have a myLearning account to register.
eirb login
eIRB Login
  • Login to eIRB at http://e-irb.jhmi.edu.
eirb accounts jhed users
eIRB Accounts: JHED Users
  • If you forget your JHED ID or JHED password:
    • Use the links (i.e., Forgot Password?) below, or
    • contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP.
eirb accounts non jhed users
eIRB Accounts: Non-JHED Users
  • Non-JHED Users must email the eIRB help desk (jhmeirb@jhmi.edu) to set up an account.
investigator home page
Investigator Home Page
  • Left Navigation Bar
    • Account Management (Non-JHED Users Only)
    • eIRB Training
    • My IRB Studies
    • Create New Application
  • Welcome Message
    • Link to Archive eIRB website
  • Studies List
    • Studies are listed by project type
investigator tabs
Investigator Tabs
  • Action Required (default tab)
    • Studies that have been returned for PI response
  • Researcher Prep
    • Studies that have never been submitted
  • In Process
    • Studies awaiting Pre-IRB or IRB review
  • Approved
    • Studies that have been Approved
  • All My IRB Studies
    • All approved, disapproved, expired, terminated, disapproved or withdrawn studies with which you are associated.
investigator workspace1
Investigator Workspace
  • Studies List
    • Your studies are listed by type.
      • New Application
      • Change in Research
      • Continuing Review
      • Protocol Event
      • Termination Report
      • Emergency Use
    • Click the study name to open the study workspace.
create a new application
Create a New Application
  • Select My IRB Studies on the left navigation bar.
  • Click the Create… button to begin a NEW eIRB application.
application workspace1
Application Workspace
  • Current Status
      • Displays the current status of the application in the submission/review process.
  • Study Vital Statistics
      • Displays the study title, number, PI, IRB committee, review type, date submitted and last scheduled review.
  • Application Waiting to be Submitted
      • Purple text will disappear upon submission of the application.
application workspace2
Application Workspace
  • IRB Review List
      • Displays the review date, review type, outcome, and letter sent (only if the application has undergone IRB review – not IRB pre-review).
  • Workspace Tabs
      • Provide quick access to study-related information.
      • Will appear as needed.
      • History Log
        • Reflects completed activities.
      • Reviewer Notes
        • Displays a collective list of IRB issues that require a response by the study team.
application workspace3
Application Workspace
  • Left Navigation Bar
      • Divided into two sections.
  • 1 – Project Editor
      • “View/Edit” provides editing access to the application.
      • “Printer Friendly” 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.
application workspace4
Application Workspace
  • Left Navigation Bar
      • Divided into two sections.
  • 2 - Current Activities
      • Displays a list of activities that may be completed.
1 general information
1 – General Information
  • Clicking the “Create…” button on the Investigator Home Page will bring you to the first page of the application.
required field
* 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.
assign application number
Assign Application Number
  • Complete all *required fields on the initial screen.
  • Click Save or Continue to create the application and assign it an IRB number.
  • eIRB application numbers begin with “IRB” and may be found in the upper right corner of the application screens.
1 general information1
1 – General Information
  • eIRB application numbers begin with “IRB”.
  • Located in the upper right corner of the application screens.
  • Save will not work until the application number is assigned by eIRB.
application screen
Application Screen
  • Title Bar
    • Application number is on the right.
  • Light Blue Tool Bar
    • 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.
    • Continue
      • Saves your work and moves you through the application one screen at a time.
hide show errors
Hide/Show Errors
    • Hide/Show Errors
  • Click to split the screen, display errors, and provide links to screens.
  • Click again to hide the split screen.
jump to drop menu
Jump To Drop Menu
    • Jump To
  • Displays list of required screens.
  • Use the list to navigate to non-consecutive screens.
help link
Help Link
  • The Help Link icons appear beside each question.
    • Click the help icon to access IRB Regulatory Guidelines and Policies and download forms/templates.
select principal investigator
Select Principal Investigator
  • Example: Clickthe Help Link icon for guidance.
select principal investigator1
Select Principal Investigator
  • Helpful information will appear above or below the question.
2 study team compliance training
2 - Study Team Compliance Training

2 – Study Team Compliance Training

  • Verify compliance training information (Q1)
  • Do not send compliance training certificates in advance of an eIRB submission.
  • If compliance training dates are incorrect or missing,upload copies of training certificates into Q2.
  • IRB Staff will enter the dates into the eIRB system upon submission.
2 study team compliance training1
2 - Study Team Compliance Training
  • Non-Hopkins affiliated study team members are also required to upload a copy of their human subjects research (HSR) compliance training certification.
8 support information monetary and material
8 - Support InformationMonetary and Material

Funding or material source not listed?

Email jhmeirb@jhmi.edu with the name of the funding or material source and we will add it to eIRB.

add update delete documents
Add/Update/Delete Documents

Add Documents

You must select “Add ” to:

  • Upload a NewDocument
add update delete documents1
Add/Update/Delete Documents

UpdateDocuments

You must select “Update” to:

  • Upload a Reviseddocument
  • View the history of a document
  • Delete a document (4. change dropdown from “Submitted” to “Deleted”)
add update delete documents2
Add/Update/Delete Documents

Delete Documents

  • Use “Update” to change the status of the document to “Deleted”
  • Click “OK”
  • A “strikethrough” will appear through the document name.
  • Click “Update” to upload the correct document
    • Remember to change the status to “Submitted” before clicking “OK”.
documents and forms
Documents and Forms
  • Things to remember…
    • IRB templates/forms must be downloaded from within the eIRB application/IRB site. Use the Help Link icon to download the latest versions of templates/forms.
    • Only electronic documents/forms are accepted in eIRB.
drill downs
Drill Downs
  • Drill downs are pages within pages.
  • Click Add to open screens requiring additional information.
drill downs1
Drill Downs
  • Answer the questions.
  • Scroll down.
  • Click OK at the bottom right corner.
drill downs2
Drill Downs
  • Save the screen or Click continue to save and move forward.
update drill downs
Update Drill Downs
  • Click Update 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.
  • Save the screen.
6 protocol information
6 – Protocol Information
  • Q1 - Select the type of protocol you wish to submit.
  • Click the icon to download the JHM-IRB eForm A (if applicable)
download eform a
Download eForm A
  • Right click the link to JHM IRB eForm A.
  • Save the template to your local drive.
      • Use a simple naming convention, including the upload date.
      • ex. eFormA_010114.doc
  • Complete the form and save it to your local drive.
upload protocol
Upload Protocol
  • Q3 - Click Add to upload the completed eForm A.
upload protocol1
Upload Protocol
  • Use the “Browse” button to locate the document.
  • Once the document is located, select the document and click “open”.
  • Click“OK” when finished.
upload protocol2
Upload Protocol
  • For new applications that have not been submitted, only a clean copy of the protocol is required.
  • Save the screen.
upload revised protocol
Upload Revised Protocol
  • Q: What happens when the IRB wants me to make changes to my protocol?
  • Download the previously uploaded protocol – make a tracked changes copy and a new clean copy.
    • Q3. Click Update to upload a new clean version.
    • Q4. Click ADD to upload the tracked changes version.
delete documents
Delete Documents

If you upload the wrong document…

  • Use “Update” to change the status of the document to “Deleted”
  • Click “OK”
  • A “strikethrough” will appear through the document name.
  • The status of the document will read “Deleted”.
delete documents1
Delete Documents
  • Click “Update” to upload the correct document
  • Remember to change the status of the updated document to “Submitted” before clicking “OK”.
document history
Document History
  • Click Update to the left of the document name.
  • Click History to the right of the document name.
  • This opens the document history window.
document history1
Document History
  • Select the uploaded file name to open the document.
add upload delete documents
Add/Upload/Delete Documents

Things to remember…

  • You must select “Add ” to:
    • Upload a NewDocument
  • You must select “Update” to:
    • Upload a Reviseddocument
    • View the history of a document
    • Delete a document (4. change dropdown from “Submitted” to “Deleted”)
  • Use “Update” to change the status of the document to “Deleted”
  • Click “OK”
  • A “strikethrough” will appear through the document name.
  • Click “Update” to upload the correct document
    • Remember to change the status to “Submitted” before clicking “OK”.
13 consent and waivers
13 – Consent and Waivers
  • Select the type of consent planned for your study.
  • Click Continue.
  • You will only see the screens relating to your selection.
download consent form template
Download Consent Form Template
  • Right click the consent form template link.
  • Save the form to your local drive.
      • Use a simple name including the upload date.
      • Consent Sample_010114.doc
      • The IRB will modify the name you give your approved consent form.
      • The modified name will appear in all letters.
  • Complete the consent form and save it to your local drive.
upload consent form
Upload Consent Form
  • Click Add to upload the completed consent form.
  • Only one version of each consent form should be visible.
upload consent form1
Upload Consent Form
  • Use the “Browse” button to locate the document.
  • Once the document is located, select the document and click“open”.
  • Click“OK” when finished.
upload revised consent form
Upload Revised Consent Form
  • Click Update to upload the tracked changes version into the consent form field.
  • This replaces, but does not delete, the previous version of the same consent.
  • A clean version of the consent form is not needed.
locate approved consent form
Locate Approved Consent Form
  • The IRB will upload a clean, approved consent directly into this application question.
  • This consent is to be used with changes in research.
  • Remember: Only one version of each consent form should be visible.
19 supplemental study documents
19 - Supplemental Study Documents
  • You may be using other documents that require IRB approval.
  • Upload supplemental study documents that require the JHM IRB approval logo into Q1.
19 supplemental study documents1
19 - Supplemental Study Documents
  • Upload supplemental study documents that do not require the JHM IRB approval logo into Q2.
  • All supplemental documents will be listed in the approval letter.
application documents
Application Documents
  • This page displays all study team documents uploaded into the application.
  • Documents can be downloaded from this screen but not uploaded on this screen.
  • Click Continue to advance to the last application screen.
application complete1
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.
application workspace5
Application Workspace
  • Select My Home at the top right and return to the Investigator Home Page.
request study team participation
Request Study Team Participation
  • Select RequestStudyTeamParticipation from the Current Activities section.
  • This opens the Request Study Team Participation Window.
request study team participation1
Request Study Team Participation
  • Optional comments may be entered into the text box.
  • Click OK. This sends out an email notification to everyone on the study team asking them to login to eIRB and complete the Agree to Participate activity.
  • Study team members may complete the Agree to Participate activity without having received the courtesy email notification.
request study team participation2
Request Study Team Participation
  • The PI will receive an email notification when all study team members have agreed to participate.
  • The History Log may also be checked to determine when all study team members have agreed to participate.
  • The PI may submit without having received the courtesy email notification, once all study team members have completed the Agreed to Participate activity.
agree to participate
Agree to Participate
  • Study team members may complete the Agree to Participate activity without having received the courtesy email notification.
  • Select the Agree to Participate activity from the Current Activities section of the left navigation bar.
  • This opens the Agree to Participate window.
slide72

Agree to Participate

  • Read the Agree to Participate window content.
  • Click Yes.
  • Select whether or not you wish to receive all study-related notifications.
  • Click OK.
  • Performing this activity is the equivalent of an electronic signature.
  • The Principal Investigator does not complete the Agree to Participate activity.
  • Submitting the change in research confirms the agreement of the PI.
slide73

Agree to Participate

  • View the History Log to see that you completed the Agree to Participate activity.
  • Select My Home to return to the Investigator Home Page.
application waiting to be submitted
Application Waiting to be Submitted
  • The PI will receive an email notification when all study team members have agreed to participate.
  • The PI may submit without having received the courtesy email notification, once all study team members have completed the Agreed to Participate activity.
submit the application
Submit the Application
  • Select Submit from the Current Activities section.
  • Only the PI will have the Submit activity.
  • This opens the submit window.
submit the application1
Submit the Application
  • Submit Window
  • Add comments or documents ONLY for information NOT included in the application.
  • Click OK to submit.
  • This is the equivalent of an electronic signature.
  • The PI does not complete the Agree to Participate activity.
  • Submitting the application is the PI’s agreement to participate.
application submitted
Application Submitted
  • Select the In Process tab.
  • Scroll down to the New Applications section.
  • Monitor the progress of your application through IRB Review (Current State).
  • Upon approval by the IRB the application will appear under the Approved tab.
reviewer notes1
Reviewer Notes
  • All applications are subject to a Pre-IRB review as well as an IRB reviewer.
  • Issues that require a response are referred to as “Reviewer Notes”.
locate an application fsa
Locate an Application/FSA
  • Scenario:
    • You received an email like this  from an IRB staff member.
  • Click on the “Link To Study Workspace” to open the application, or…
locate an application fsa1
Locate an Application/FSA
  • Select the Action Required tab.
  • Scroll down to the New Applications section.
  • Click on the study name to open the application workspace.
reviewer notes2
Reviewer Notes
  • IRB staff will add reviewer notes to the applicable sections of the eIRB application.
  • The PI/study team must respond to each reviewer note and make revisions to the application (if applicable)
  • Select “Click here to respond…” to enter a response.
reviewer notes3
Reviewer Notes
  • Click “Ok” to save your response. Your response will be highlighted in green when complete.
reviewer notes4
Reviewer Notes
  • To edit your response, click on “Study Team Response”.
  • Click OK to save.
reviewer notes5
Reviewer Notes
  • You can also track and respond to reviewer notes using the “Reviewer Notes” tab on the Application Workspace.
re submit the application
Re-Submit the Application
  • Select Submit from the Current Activities section.
  • Only the PI will have the Submit activity.
  • This opens the submit window.
submit the application2
Submit the Application
  • Submit Window
  • Add comments or documents ONLY for information NOT included in the application.
  • Click OK to submit.
  • The PI has 60 days to respond to IRB reviewer notes.
  • Failure to respond will result in an administrative withdraw of the application.
  • The PI can request an extension to respond to IRB issues.
request extension pre irb
Request Extension – Pre IRB
  • An application may be returned as incomplete after assignment to an IRB and before going to an IRB Committee for review.
  • The Principal Investigator has 60 days to resubmit the application.
  • You may seek a 60 day extension of this time limit.
application workspace pre irb
Application Workspace – Pre IRB
  • Click Request Extension - Pre IRB from the Current Activities section.
  • This opens the Request Extension – Pre IRB window.
request extension pre irb1
Request Extension – Pre IRB
  • Request Extension - Pre IRB window
  • Click OK.
  • Completing this activity automatically grants a 60 day extension to respond to the IRB.
request extension post irb
Request Extension – Post IRB
  • You may seek an extension for the submission of a response to the IRB issues waiting to be addressed.
  • You must submit a request in eIRB before the original response due date.
  • Responses cannot be accepted beyond the deadline without a JHM IRB approved extension.
  • Only the Principal Investigator may submit the request. 
application workspace post irb
Application Workspace – Post IRB
  • Click Request Extension – Post IRB from the Current Activities section.
  • This opens the Request Extension – Post IRB window.
request extension post irb1
Request Extension – Post IRB
  • Request Extension – Post IRB window
  • Enter your reasons for requesting an extension.
  • Click OK.
  • Completing this activity sends an email notification to the IRB office to consider your request.
  • You will receive an email response from the IRB.
withdraw application
Withdraw Application
  • The PI can opt to withdraw the application prior to IRB submission or after initial IRB review.
  • Only the PI may withdraw an application.
  • For Applications in Researcher Prep, click PI Withdraw Study from the Current Activities section.
  • This opens the Withdraw window.
withdraw application1
Withdraw Application
  • Click OK.
  • This inactivates the application in eIRB.
  • If you wish to pursue this study in the future, a new eIRB Application must be created and resubmitted for IRB review.
  • The study will appear as read-only under the All My IRB Studies tab on the Investigator Home Page.
pi response pre post irb
PI Response – Pre/Post IRB
  • Request Withdraw – PI Response – Pre/Post IRB
  • Only the PI may withdraw an application.
  • For Applications in PI Response – Pre/Post IRB, Click Request Withdraw from the Current Activities section.
  • This opens the Request Withdrawal window.
pi response pre post irb1
PI Response – Pre/Post IRB
  • Click OK.
  • Completing this activity sends an email notification to the IRB office to consider your request.
  • You will receive an email notification confirming the withdrawal.
  • If you wish to pursue this study in the future, a new eIRB Application must be created and resubmitted for IRB review.
  • The study will appear as read-only under the All My IRB Studies tab on the Investigator Home Page.
locate unstamped documents
Locate Unstamped Documents
  • Upon approval, IRB staff will provide you with clean, unstamped versions of your documents.
  • Documents are uploaded directly into the application under the appropriate questions.
locate unstamped documents1
Locate Unstamped Documents
  • These documents are to be used with changes in research.
  • Only one version (clean on top, tracked and previous versions underneath) of each document should be visible.
locate stamped documents
Locate Stamped Documents
  • Upon approval, IRB staff will also provide you with IRB stamped versions of your documents.
  • Select the Stamped Documents tab .
  • Click on the document name to open.
  • Use these stamped documents with study participants.
further study actions
Further Study Actions
  • All actions on an Approved study fall under the umbrella term Further Study Action (FSA).
  • This includes:
    • Continuing Review
    • Changes in Research
    • Protocol Event
    • Emergency Use Request
    • Termination Report
further study actions1
Further Study Actions
  • A second FSA of the same type for the same study may not be submitted until the first has completed its review.
  • Protocol Events may be submitted at any time.
create a further study action
Create a Further Study Action
  • Select My IRB Studies from the left navigation bar.
  • Select the Approved tab on the Investigator Home Screen.
  • Scroll down to the New Applications section.
  • Select the currently approved study.
  • This opens the application workspace.
create a further study action1
Create a Further Study Action
  • Under Current Activities, locateCreate Further Study Action.
  • Click Create...
create a further study action2
Create a Further Study Action
  • Select the type of FSA to be createdand select Continue.
  • You can only select one FSA at a time.
  • Once the FSA has been created, you can return to this screen, following the previous steps, to select a different type of FSA.
locate a further study action
Locate a Further Study Action

Option 1 – FSA Tab

  • Select the Further Study Actions tab on the Application Workspace.
  • This displays a list of ALL FSAs.
  • Select the FSA name to open the FSA workspace.
locate a further study action1
Locate a Further Study Action

Option 2 – Investigator Workspace

  • Select My IRB Studies from the left navigation bar.
  • Select the appropriate tab (i.e., Action Required).
  • Scroll down to the FSA projects.
  • Select the FSA name to open the FSA workspace.