WEBVTT

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In this video,
we'll walk through the process of

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developing research protocol,
starting from where to locate the

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protocol templates,
how to locate the correct template,

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and finally how to fill it out and upload
the protocol to the study form.

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A research protocol is the CORG document
in your IRB submission.

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It provides a complete description of
your study, what you're doing,

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how you'll conduct it,
and how you'll protect participants.

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The research protocol is the only
document that is required to be attached

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when submitting a study for IRB review.

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To find the protocol documents,
start by clicking on the IRB tab,

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then the Library tab.

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The protocol documents will appear under
the Templates tab.

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The templates that will be available to
you may differ slightly from what you see

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on the screen here.

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For information about which template to
choose,

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check out the HRPP Toolkit section of the
IRB Reference Guide for Campus and HRPP.

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To fill out the protocol template,
first click on the name of the document

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you want to open.

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This will automatically download the file
to your computer.

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Open the file to begin making edits.

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Carefully read over the instructions at
the top, making note of the following.

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For any sections not applicable to your
research, mark as NA.

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As you're writing the protocol,
remove the instructions and italics after

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you've completed this section so it's not
in your final version amid the starred

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sections.

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If this is the activation of a protocol
as a new site or sites that will be

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overseen by a principal investigator who
will take separate and full

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responsibility for that site or those
sites,

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go through each of the sections and fill
out the information about your study.

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Replace the information in italics with
what it describes here.

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You'll notice in question 11 it mentions
reviewing a checklist to find what it's

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referencing.

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Go back to the Library section and click
on the Checklist tab to locate what the

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protocol template is referencing.

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Go back and continue to fill out the
protocol template.

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In question 22,
it references an SOP document.

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This stands for Standard Operating
Procedure.

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To find this,
go back to the Library tab and click on

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Standard Operating Procedures.

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Click on the documents to download them
to your computer.

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In question 23, it references a template.

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To find the template,
go back to the Library tab and click on

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the Templates tab.

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Here you can see all the templates
available to you.

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Continue filling out your protocol.

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Once you have finished,
save an electronic copy.

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You'll need this to modify the copy when
making changes.

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Once you've completed and saved your
protocol,

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upload your protocol to Question 8 on the
Creating New IRB submission form where it

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asks you to attach to the protocol.

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You have successfully created and
uploaded your study protocol.

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For more information,
please visit the training site.

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Thanks for watching.