eIRB 101: Prepare and Submit an eIRB Application
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Transcript of eIRB 101: Prepare and Submit an eIRB Application
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• 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
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• 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expired, terminated, disapproved or withdrawn studies with which you are associated.
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• Select My IRB Studies on the left navigation bar.
• Click the Create… Create… button to begin a NEW eIRB application.
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• 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.
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• 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.
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• 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.
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• Left Navigation Bar– Divided into two
sections.• 2 - Current Activities
– Displays a list of activities that may be completed.
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• 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.
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– Hide/Show Errors Click to split the screen,
display errors, and provide links to screens.
Click again to hide the split screen.
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– Jump To Displays list of required
screens. Use the list to navigate to
non-consecutive screens.
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• The Help Link icons appear beside each question.– Click the help icon to
access IRB Regulatory Guidelines and Policies and download forms/templates.
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• Example: Click the Help Link icon for guidance.
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• Helpful information will appear above or below the question.
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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.
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• Click Add to upload the completed consent form.• Only one version of each consent form should be
visible.
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• 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.A clean version of the consent form is not needed.
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• 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.
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• Select My Home at the top right and return to the Investigator Home Page.
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• 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.
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• 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.
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• 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.
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