WEBVTT

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Welcome to the training on how to create
and submit a single site study.

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In this video,
we'll walk through how to create and

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submit a single site study,
from getting started to successfully

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submitting it for review.

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Let's begin.

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Before creating your study,
take a few moments to gather the files

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and information you'll need.

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This may include your study protocol,
consent forms,

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or any other study specific documents.

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To create a study,
start from the dashboard.

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Click the Create menu and select Create
New Study.

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This will open up the submission form.

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Fill out the title of the study,
The short title.

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The short title will be the title that
appears in the IRB system and a brief

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description.

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In the description,
summarize the central question the

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research is intended to answer,
the primary objectives,

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and the methods used.

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For the sake of time,
I'll just write in something brief.

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Select the review pathway you're
requesting for the question.

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What kind of study is this?

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Select Single Site Study Answer Yes or no
for if an external IRB will act as the

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IRB of record.

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Select the local principal investigator.

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Your name will automatically be added
here, but if you'd like to change this,

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click on the three dots to select another
person to serve as the principal

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investigator.

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Attach the protocol.

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If the sponsor's protocol is not provided,
there's a protocol template provided in

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the Library tab.

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For information on where the Library tab
is located, see the Intro to IRB video.

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If an ancillary review is required,
select the group that will complete the

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ancillary review.

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Click Continue to move to the next page
on the Study Funding Sources page.

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Identify all external funding sources
such as industry sponsors and government

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agencies by clicking Add.

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Here you can have the information about
the funding organization.

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Click Continue to move to the next page
on the Local Study Team Members page.

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Identify each additional person involved
in the design, conduct,

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or reporting of the research by clicking
Add.

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You do not need to add the Principal
Investigator here since you already did

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this on the Basic Study Information page.

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Adding the external team member
information here.

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Click Continue to move to the next page
on the Study Scope page.

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Answer Yes or No to identify any factors
involved in the study that might require

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review of additional details.

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If you answer yes,
additional pages will appear on the study

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form to show you what that looks like.

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I'll click yes for question 2.

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As you can see,
the device page has appeared.

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For the sake of time,
I'm going to go back and click no on the

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Local Research Locations page.

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Identify locations where research
activities will be conducted or overseen

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by the local investigator by clicking Add
and choosing a location.

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If the location is not listed in this
drop down,

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you can enter the information here.

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Click Continue on the local site
documents page.

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Upload documents specific to your study,
such as consent forms and recruitment

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materials.

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When you reach the final page,
click Finish.

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It's important to know that Click and
Finish does not submit the study to the

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IRB.

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At this point,
the study remains in the pre submission

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state.

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You're now taken back to the study
workspace where you can continue to make

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edits using the Edit Study button until
you're ready to submit.

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When your study is complete and ready for
review,

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it must be submitted by the Principal
Investigator or an assigned Pi proxy from

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the workplace.

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Click Submit,
review these terms and click OK to agree.

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Your study has now been successfully
submitted and has moved into the pre

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review state.

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You can safely log out of the system.

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Congratulations,
you have successfully created and

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submitted a single site study for IRB
review.

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For additional information,
please check out the training site.

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Thanks for watching.