Transcript http://e-irb.jhmi.edu • Tool Bar – eIRB Helpdesk  Step by step instructions and tutorials  Contact information – eIRB Survey  submit your feedback to the IRB –

http://e-irb.jhmi.edu
• Tool Bar
– eIRB Helpdesk
 Step by step instructions and
tutorials
 Contact information
– eIRB Survey
 submit your feedback to
the IRB
– What’s New
 Learn about updates to
the eIRB system, forms,
etc.
• Grey “Breadcrumb Trail”
– Tells where you are in eIRB
• Left Navigation Bar
– Account Management (Non-JHED
Users Only)
– eIRB Training
– My IRB Studies
– Create New Application
• Studies List
– Studies are listed by project type
• 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or withdrawn studies with which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
• Select My IRB Studies
on the left navigation
bar.
• Click the Create…
button to begin an eIRB
application.
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– Hide/Show Errors
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Click to split the screen, display
errors, and provide links to
screens.
Click again to hide the split screen.
– Jump To
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Displays list of required screens.
Use the list to navigate to nonconsecutive screens.
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• * Required
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• Complete all *required fields on the initial screen.
• Click Save 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.
• The Help Link icon appear
beside each question.
– Click the “?” icon to access
IRB Regulatory Guidelines
and Policies and download
forms/templates.
• Application Waiting to be
Submitted
– Purple text will disappear
upon submission of the
application.
• Study Vital Statistics
– Displays the study title,
number, PI, IRB Committee,
review type, date submitted
and last scheduled review.
• Current Status
– Displays the current status of
the application in the
submission/review process.
• 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 studyrelated 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.
• Left Navigation Bar
– Divided into two sections.
• View/Print New Application
– View/Edit 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.
• Left Navigation Bar
– Divided into two sections.
• Current Activities
– Displays a list of activities that
may be completed.
• Select My Home at the top
right and return to the
Investigator Home Page.
• Add comments or documents
for information
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.
• Upon approval by the IRB the
application will appear under
the Approved tab.
• Select View.
• This opens up the
application screens.
FSA
• Click Continue to
advance to the screen
you want.
or
• Click the down Jump To
arrow.
• Select the screen.
• 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.
• 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.
• Upon approval, IRB
staff will 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.