WEBVTT

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In this video,
you'll learn how to create and submit a

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modification for an active study in the
IRB system.

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There may be times when you need to
update parts of your study after it's

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already been approved,
whether that's changes to the protocol,

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consent forms, study team members,
or other study details.

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When that happens,
you'll submit a modification through the

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system.

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We'll now walk through the process step
by step.

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To get started,
you'll need to navigate to the study you

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want to modify.

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Click the IRB tab in the top navigator,
then the Active tab,

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and click on the study name to open the
study workspace.

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From the study workspace,
click the Create Modification slash CR

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button on the left side.

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This opens the Creating New IRB
submission form.

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You'll see the question What is the
purpose of this submission?

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Click Modification slash Update.

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Next,
we'll need to define the modification

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scope.

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This is where you select which parts of
the study you'd like to modify.

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Your options may include other parts of
the study, study team member information,

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or more.

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Select the appropriate scope and clip.

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Continue.

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An important thing to note here,
if you've already submitted A

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modification that's currently under
review,

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you'll need to wait for that review to be
completed before you can submit another

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modification of the same type.

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You'll see here there is an active
modification going for the study.

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The modification type was study team
member information,

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so Study team member information is not
listed as one of the selections you can

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choose from for the modification scope.

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Once you've selected your modification
scope, you can click Continue.

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Next,
you're taken to the Modification

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Information page.

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Fill out this page with a summary of what
you're changing and why.

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This helps the IRB understand the purpose
of your modification.

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Once you have completed this page,
click Continue.

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Since the modification scope we selected
was other parts of the study,

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it'll allow us to make changes to all of
the study pages.

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Go through each of the different pages
and make your modifications click and

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continue to move to the next page.

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Take your time here to ensure all of the
changes are accurately reflected.

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When you finish making all of your
updates, click Finish.

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After clicking Finish,
you'll be taken to the Modification

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workspace.

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This is where you'll officially submit
your changes to the IRB.

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Click the Submit button,
then click OK to confirm the verification

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statement.

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Congratulations,
your modification has been successfully

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submitted.

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The system will move it into the pre
review state, seen here,

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where the IRB will begin processing your
request.

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After you've submitted,
you may want to check on the status of

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your modification.

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There's two ways to do this.

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Option one is to click on the IRB tab in
the top navigator,

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then select the In Review tab.

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Right here you'll see your modification
listed here.

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Click on the name to open it and check
the status.

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Option 2 is to use the breadcrumb trail
at the top of the page to navigate back

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to the original study,
then click on Follow on Submissions.

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This tab shows all modifications,
continuing reviews,

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and other follow on submissions
associated with your study.

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One more thing to keep in mind is if you
try to modify the study again while your

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current modification is still active,
you'll only be able to modify the areas

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you didn't just modify.

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This is because the system prevents
overlapping modifications to the same

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sections.

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Once your submitted modification is
reviewed and completed,

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those sections will become available for
editing again.

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You have now completed the process of
creating and submitting A modification.

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For more information,
please check out the training site.

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Thanks for watching.