Audio Transcript Auto-generated
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Hello. My name is Heather Park. May
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I am the I. R. B.
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Training coordinator at Wayne State University's
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institutional review board or I.
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R. B.
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This on demand Education is part three of a three part series about the basics.
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To help find your way through I. R. B. Review
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please watch parts one and two of the fundamentals of the I. R. B.
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Education on demand videos before completing with part three.
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In this session I will discuss details
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about data collection strategies for maintaining confidentiality
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tips to prevent noncompliance and some basic tips for getting started with your I.
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R. B. Submission in the protocol.
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Now conducting research is all about data collection.
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We can we can collect primary data for analysis which is
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generally uh generated specifically for research using methods such as surveys,
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questionnaires, observations or measurements.
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All prospective lee correct collected data.
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We can also collect secondary data which is data that has been
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generated for reasons unrelated to the research such as student records,
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medical records,
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leftover bio specimens from a standard of care
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medical procedure such as a biopsy tissue.
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Um
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In either in either case it's important to
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understand the difference between identifiable and de identified
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data so that you can develop a detailed plan for how your research will be.
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Higher research data will be generated collected,
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analyzed and stored which should be included in your research protocol and your I.
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R. B. Application.
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We have a comprehensive guide to data collection available on our I. R. B.
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Education website. I have the link here below.
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I recommend reviewing this guidance before getting started with any I. R. B.
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Submission while you are still in the process
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of planning your study and developing your protocol.
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So going a little more deep,
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a little deeper into identifiable data versus de identified data
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and identifiable data.
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Uh set is any data set that
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includes direct personal identifiers or any combination of
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data sets that would make it possible
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for the researcher to identify the participants.
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This includes coded data.
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If you must retain individual identifiers,
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you should code that data so that direct identifiers
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are kept separately and linked to your aggregate data.
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Using a code.
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The aggregate data and the master list must be stored in separate files
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in an encrypted server.
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The master list should never be shared outside of the
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university unless there is justifiable need with the data use agreement
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coded data is identifiable as long as it is possible for
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investigators to identify the participants with the data available to them.
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If the master list that links the identity of the participants to
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the aggregate data is destroyed then your data becomes de identified.
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So as long as your if if
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data available to investigators is makes it
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possible for investigators to readily ascertain the identity
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of the participants then you have identifiable data.
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Otherwise we consider it de identified.
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So one risk that exists in all human
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participant research protocols is the breach of confidentiality.
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This risk is often overlooked. So it's important to recognize the risk in I. R. B.
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Applications of your research protocol and consent document.
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If applicable steps must be taken to minimize all risks identified
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and research including the risk for a breach of confidentiality.
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So to minimize this risk,
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some things you can do here number one,
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make sure you're collecting only the minimum data necessary.
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Do not keep identifiable data if you don't need
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it do not share identifiable data with others.
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Store identifiable data on an encrypted server.
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Just a note.
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Wayne State University provides one drive for all staff students and faculty.
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This is a an encrypted server. This is a cloud based encrypted server.
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Do not use google drive.
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This is not it's not encrypted and it's not a safe way
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to store data and never store data on a personal laptop.
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So some tips to maintain compliance.
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There are several things that can be done to prevent occurrences of noncompliance
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that need to be that would need to be reported to the I.
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R. B. And an unanticipated problem report.
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So to avoid that I'm about to share with you simple steps that you can
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take to prevent some of the more common
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errors that researchers make as Benjamin franklin.
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Once said
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an ounce of prevention is worth a pound of cure
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started talking about consent.
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One common area where we see noncompliance is with the consent process.
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Informed consent is arguably the most important
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responsibility of investigators conducting human participant research.
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So there are several things that researchers can
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do before during and after consent is obtained,
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to minimize opportunities for errors.
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So what can we do before you start the process?
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Take uh make sure that the
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knowledge researcher obtaining consent is knowledgeable
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about the research protocol and able to answer the participants questions.
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This person also needs to be familiar
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with the IRB's requirements for obtaining consent
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and listed in the I. R. B.
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Approved protocol as research personnel authorized to obtain consent.
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Make sure that the participant has completed all screening procedures and
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meets the enrollment criteria before you begin the enroll the consent process
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and then make sure that the current I. R. B.
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A perversion of the consent form is available.
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When the participant arrives,
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participants should never be presented with an
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outdated version of the consent form.
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So whenever a new version of the consent form comes out and is approved by the I. R. B.
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All previous versions should be removed from circulation
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and then block plenty of time for each participant scheduled so that um you have
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enough time to discuss the consent in and ensure that the process is not rushed,
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rushed and the participants are able to have all of their questions answered.
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So taking these steps before the potential participant arrives to
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discuss the consent form will help prevent potential noncompliance.
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Now, during the consent process,
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make sure that the participants questions are answered.
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The researcher obtaining consent should be aware
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of the participants ability to understand the
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information and feel confident that their consent
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was informative and given voluntarily before proceeding.
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Before the participant leaves.
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Look over the consent form to check for any documentation errors.
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Um Some common things to look for.
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Make sure that the participant has initial the bottom of every page,
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even the signature page.
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All appropriate individuals have signed the right lines on the
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signature page and the hippo authorization page if that applies.
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Um that has a separate signature page
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and the date the participant has signed
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is within the approval period provided in the I. R. B. Approval stamp,
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participants should never sign a consent form that does not have an I. R. B.
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Approval stamp.
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Things you can do after the consent is
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documented after you've completed the initial consent process.
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Your job is not over one provide the participant with
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a copy of the of the signed consent form securely store
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the consent form in a manner that will allow you
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to easily locate it in the event of an audit.
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And then if you find there are consent errors.
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Um minor errors such as a page that was not initialed or the
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participant may have signed on the wrong line or other minor documentation errors.
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They can be noted uh in a documented in a note to file,
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Make sure that that describes the minor error and
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it gets a signature from the person who discovered the
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error and um prepared the note to file as well
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as the person who obtained consent and the P.
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I.
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More significant errors
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do need to be reported to the I. R. B.
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By submitting an unanticipated problem for him.
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Some examples of that include an outdated,
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the use of an outdated consent form or consent obtained during a lapse of I.
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R. B.
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Approval or if consent was obtained by research personnel
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that has not yet been approved by the I.
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R. B. Those are more significant errors. They need to be submitted uh notified.
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The army needs to be notified through an unanticipated problem report
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and then continue consent is also important if there are
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any changes to the study after the participants sign this
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consent form that involves changes in risks or any other
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change that could impact the participants willingness to continue.
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Uh such as an additional follow up visit um that might conflict with their schedule.
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You know, the participants continue consent needs to be reaffirmed.
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So when we talk about regulatory compliance, these things here really seem basic.
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But it is the often the rudimentary procedures that
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are not given enough attention that should be prioritized.
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So consistency is key here really. Communication is important.
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Make sure that there's clear and consistent communication
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with everyone involved in the research.
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Communication on the Research Protocol procedures,
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things that are going on uh and regulatory issues.
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If there's ever a lapse in approval.
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Um The research coordinator or individual responsible for regulatory reporting,
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needs to notify the entire study team
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that all research related activities needs cannot continue
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until that the IRB has approved
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the continuing view and extended the expiration date
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and then write it down. Everything used to be documented.
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If it didn't get documented it didn't happen.
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And conduct regulatory,
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regular scheduled quality checks on all aspects of the research if you
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get ahead of it and you're looking through all your regulatory reporting,
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your consent documentation,
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research procedures and data safety monitoring etcetera uh and
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making sure that things are being done correctly.
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Then you can catch problems that may arise before you know,
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a regulatory agency finds it
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and promptly report unanticipated problems to the I. R. B. Uh to do that.
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Just make sure that you're familiar with our policy
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uh and uh and that's posted on our website.
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All of our policies are posted on our website.
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So just make sure you have a basic understanding of where to find that
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documentation revisiting again, Revisiting the doctor.
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The basics is helpful uh consistency is important.
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So doing these things consistent consistently can create a clear
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picture of how things are done with your research.
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Meticulous documentation and organization will prevent
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some mistakes from being made.
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Could identify some mistakes that need to be addressed and will assure any I. R. B.
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Sponsors sponsor monitor or regulatory auditor that
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things are being done correctly and responsibly.
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Study management is also important.
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Um You don't want important dates and study milestones to sneak
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up on you so make sure that more than one member of
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the research team is receiving and monitoring notifications that would alert
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you to uh important dates such as the study expiration date or
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the city training expiration dates.
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Many lapses of I. R. B.
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Approval occur when the research personnel responsible for keeping track of the I.
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R. B. S.
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Exploration leaves the institution without designating somebody
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else to take on that role.
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So if um if you do not stop all research activity on
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the day of the study expires you are conducting research without I.
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R. B. Approval and that is serious noncompliance.
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So something to keep in mind.
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Now jumping into E. Protocol tips. Some things to keep in mind. This is R. E.
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Protocol as RB submission system and management system.
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The system can be tricky to navigate for the first few times that you use it.
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So don't fear we have a great deal of
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support to assist you through the submission system.
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And so here are some tips to help uh these
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can help you troubleshoot through any problems that you encounter.
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Um
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Here's where you can access the login information.
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You can go to our website and just click E. Protocol.
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The link that has a little star next to it,
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click log in and uh and that will get you to where you need to be
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some instructions to get you started. Number one login.
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Use your user name and password that would be your wayne state University access I.
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D. And the password associated with that
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click create protocol and then you know work through the application provide the
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information that's asked and then once your
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submission is complete you have everything you
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need there do the check for completeness one of the uh you'll find that
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blue tab located near the bottom of the right hand side of the window
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um that will pop up and flag anything that yet need has yet to be addressed.
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And uh and then make sure that the investigator
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conflict of interest disclosure and signatures are all completed.
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You've got your departmental approval done and then you can submit to the I. R. B.
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So some helpful resources we have available um
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to get started we've got live E protocol support available every Tuesday at one PM
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monthly I. R. B. Update webinars take place on the last Tuesday of every month.
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We have our education website is where you'll
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find are you Well you've probably been there
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because that's where I are beyond demand training
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video library is where you access this video.
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We have guidance documents there on a number of
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topics and eat protocol guidance tools and submission checklists.
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This is also where you'll find the information that you need to
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connect to our E protocol office hours on Tuesdays and our I.
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R. B. Update webinars
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and then you can email guidance and support to the following address is here and uh,
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and so that summarizes things for for us.
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Um, there's references where all the information was found.
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If you have any questions, feel free to shoot them to.
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I r B questions at wayne dot e d u,
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I am the person that monitors that inbox and
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I'll be happy to help answer those questions or
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find somebody who can
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thank you for your time today.
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I hope you found this information useful and I
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look forward to answering your questions in the future.