WEBVTT

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In this video,
you'll learn how to submit reportable new

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information, often referred to as RNI.

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This may be an adverse event,
potential risk,

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or any other information that the IRB
needs to know about.

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Any registered user of the IRB system can
report new information.

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There are three places where you can
create an RNI submission.

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The first is from the dashboard.

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Click the Create button and the Report
New Information button.

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The second is on the IRB tab.

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Click Submissions,
then click Report New Information.

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The third is from an active study
workspace.

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I'll go to an active workspace and you
can see the button on the left side

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Report New Information.

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For this video I'm going to start from
the dashboard.

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This will take you to the RNA form.

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The form is titled Reportable New
Information and it will walk you through

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several key questions.

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Question 1 asks for a short title.

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Give it a brief descriptive name to help
identify this report later.

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Next,
list the date that you became aware of

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the new information.

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Click on the calendar to choose the date.

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Question 3.

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This is where you identify the categories
that represent the new information.

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Check all the categories that apply.

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These may include things like risk
information,

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unanticipated adverse device effects,
protocol violations, suspensions,

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complaints, or more.

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I'll choose risk next.

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Briefly describe the new information.

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Provide a clear,
concise summary of what happened or what

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you've learned.

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Questions 5 through 6 ask for your
opinion.

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You'll answer the three questions.

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Does the information indicate a new
increased risk or safety issue?

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Click on this?

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If you want a little help with this field,
this will provide you some guidance on

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whether it indicates a new or increased
risk or safety issue.

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I'm going to answer yes.

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Does the study need revision?

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I'll select no.

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Does the consent need revision?

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I'll also select no.

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If I had clicked yes,
I would have needed to list revisions

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that are required up in the description
here for question 8.

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If this relates to any current studies or
modifications,

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you can choose them here by clicking on
the Browse button.

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If any supporting information is needed,
you can click Add to attach that here.

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Click Continue.

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You have now reached the final page.

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Click Finish to finish the form.

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This now brings you to the RNI workspace.

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This is in the pre submission state so
that means you still need to submit the

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RNI.

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Click the Submit RNI button on the left
side.

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This will bring up the verification
window.

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Click OK to verify the above statement.

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The RNI is shifted to the pre review
state now that it's been submitted.

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After you've submitted your RNI,
if you want to find it again,

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click the IRB tab in the top navigator
and then the New Information Reports tab.

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Here we can see the RNI we just submitted.

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Congratulations,
you have now completed the process of

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creating and submitting an RNI or
reportable new information.

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For more information,
please check out the training site.

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Thanks for watching.