WEBVTT

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Welcome to the training on creating and
submitting a multi site study.

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

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submit a multi site study,
including how to manage participating

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sites and submit the study for IRB review.

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Let's get started.

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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.

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And a brief 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 something short.

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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 multi site or collaborative study.

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Answer yes or no for Will an external IRB
act as the IRB of record for the study?

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Click no for this question Will your IRB
act as a single IRB of record for other

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participating sites?

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Answer yes or no.

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I'm going to answer yes.

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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.

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On the Study Funding Sources page,
identify all external funding sources,

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such as industry sponsors and government
agencies.

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To add a funding source,
click Add and fill out the information

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here.

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For the sake of time,
I'm going to leave this blank.

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Click Continue 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 don't 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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Add any external team member information
here,

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and do this by clicking Add for both.

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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.

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For the sake of brevity,
I'm going to answer no to both.

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Click Continue on the 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 the drop
down, you can enter the information here.

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To keep things short,
I'm not going to add a research location.

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On the Study Related Documents page,
add any forms that are specific to the

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study, then click Continue.

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Do the same on the Local Site Documents
page.

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On the final page, click Finish.

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It's important to note here that the
study has not been submitted yet,

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as you can see by the status being in the
pre submission state.

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After creating the study,
you can begin managing participating

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sites.

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While the study is in the Pre Submission
or Pre Review clarification requested

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states you can add or delete sites.

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Once the study reaches Pre Review
completed, you can still add sites,

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but you can no longer delete them.

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Instead,
sites can be deactivated if needed.

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To manage participating sites,
start on the study workspace and click

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Manage Participating Sites.

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Click Add, then use the...

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to select an institutional profile and
assign a principal investigator.

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Repeat this process to add any additional
institutions, then click OK When finished.

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The sites will remain in a pending
creation state until the study is

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submitted.

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You can view these sites by clicking on
the Sites tab.

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Once the study reaches Pre Review
Completed,

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the participating sites are automatically
created.

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You can also add sites later using Add
Participating Sites following the same

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steps.

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Keep in mind,
once participating sites are added,

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the study cannot be withdrawn until all
sites are inactive or discarded.

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Now that your study is created and
participating sites are managed,

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it's time to submit the study for review
from the workspace.

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Click Submit,
Review the terms and click OK to agree.

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Now that the study has been submitted,
it's moved into the pre review state.

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At the same time,
the principal investigators and primary

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contacts were all invited.

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Participating sites have been notified.

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You can now safely log out of the system.

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Congratulations,
you have successfully created and

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submitted a multi 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.