eIRB Login - Johns Hopkins Medicine
Download
Report
Transcript eIRB Login - Johns Hopkins Medicine
http://www.hopkinsmedicine.org/institutional_review_board
http://e-irb.jhmi.edu
[email protected]
410-955-HELP
[email protected]
• 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
• 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or withdrawn studies with which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 a NEW
eIRB application.
• 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.
• 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.
• 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.
• Left Navigation Bar
– Divided into two sections.
• 2 - Current Activities
– Displays a list of activities that
may be completed.
*
• * Required
•
•
•
*
• 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.
•
–
•
–
–
–
–
–
– Hide/Show Errors
Click to split the screen, display
errors, and provide links to
screens.
Click again to hide the split screen.
– Jump To
Displays list of required screens.
Use the list to navigate to nonconsecutive screens.
• The Help Link icons appear
beside each question.
– Click the help icon to access
IRB Regulatory Guidelines and
Policies and download
forms/templates.
• Example: Click the Help
Link icon for guidance.
• Helpful information will
appear above or below the
question.
[email protected]
New
Revised
Submitted
Deleted
• Remember to change the status to “Submitted” before clicking “OK”.
–
–
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.
If you upload the wrong document…
• Remember to change the status of the updated document to
“Submitted” before clicking “OK”.
New
Revised
Submitted
Deleted
• Remember to change the status to “Submitted” before clicking “OK”.
–
–
–
–
• Click Add to upload the completed consent form.
• Only one version of each consent form should be visible.
• 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.
• 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.
• Select My Home at the top
right and return to the
Investigator Home Page.
• Study team members may
complete the Agree to
Participate activity without
having received the courtesy
email notification.
• The PI may submit without
having received the courtesy
email notification, once all
study team members have
completed the Agreed to
Participate activity.
• 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.
• Add comments or documents
for information
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.
• For Applications in
Researcher Prep
• For Applications in PI
Response – Pre/Post IRB,
• 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 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.