WEBVTT

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<v Permana, Paskasari A.>Be addressed by the presenter.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/290-0
00:00:20.448 --> 00:00:23.690
<v Permana, Paskasari A.>We encourage emoji reactions during
presentation,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/290-1
00:00:23.690 --> 00:00:27.968
<v Permana, Paskasari A.>and we remind you to complete the post
Webinar evaluation survey.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/301-0
00:00:28.738 --> 00:00:31.858
<v Permana, Paskasari A.>Please submit your feedback to help us
improve and determine the type of.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/317-0
00:00:32.208 --> 00:00:36.731
<v Permana, Paskasari A.>Of topics for future webinars,
the link to the webinar survey will be</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/317-1
00:00:36.731 --> 00:00:39.768
<v Permana, Paskasari A.>posted in the chat at the end of this
webinar.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/337-0
00:00:41.208 --> 00:00:45.764
<v Permana, Paskasari A.>And the webinar recording will be also be
made available at the E Pros Webinar</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/337-1
00:00:45.764 --> 00:00:48.128
<v Permana, Paskasari A.>Archive within seven days of the webinar.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/384-0
00:00:49.048 --> 00:00:55.089
<v Permana, Paskasari A.>Now this is just a reminder that to get
to receive notifications on April Ord</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/384-1
00:00:55.089 --> 00:00:59.116
<v Permana, Paskasari A.>webinars,
please e-mail Vaiko T3 training at VA Gov</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/384-2
00:00:59.116 --> 00:01:04.770
<v Permana, Paskasari A.>to be added to the distro list.
You should then receive the notification</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/384-3
00:01:04.770 --> 00:01:10.578
<v Permana, Paskasari A.>unless the presenters choose a very
specific target audience when you get.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/390-0
00:01:10.578 --> 00:01:12.248
<v Permana, Paskasari A.>A webinar notification.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/403-0
00:01:12.328 --> 00:01:16.751
<v Permana, Paskasari A.>Please accept the calendar invite,
even if tentative and you don't plan to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/403-1
00:01:16.751 --> 00:01:18.048
<v Permana, Paskasari A.>attend a live webinar.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/421-0
00:01:18.448 --> 00:01:22.654
<v Permana, Paskasari A.>So you can access the chat and have
immediate access to the recorded webinar</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/421-1
00:01:22.654 --> 00:01:24.128
<v Permana, Paskasari A.>and presentation materials.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/439-0
00:01:25.618 --> 00:01:28.311
<v Permana, Paskasari A.>In a few moments,
I'll upload the slides and release the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/439-1
00:01:28.311 --> 00:01:30.578
<v Permana, Paskasari A.>documents for today's presentation in the
chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/480-0
00:01:31.968 --> 00:01:37.372
<v Permana, Paskasari A.>So for today's presentation,
I'm excited to introduce our presenter,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/480-1
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<v Permana, Paskasari A.>Laura Caddis,
who will discuss Bears MTA DUA or Dear</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/480-2
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<v Permana, Paskasari A.>Review Board and a dua reference
documents.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/486-0
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<v Permana, Paskasari A.>So now I'm going to hand this over to the
presenter, Laura.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/490-0
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<v Dejong, Christin B.>Make sure you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/497-0
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<v Permana, Paskasari A.>Great. I. Yeah, I think I can see your.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/504-0
00:02:17.428 --> 00:02:21.188
<v Permana, Paskasari A.>Laura can use share your screen.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/509-0
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<v Kaddis, Laura J.>Oh, and I was muted.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/511-0
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<v Kaddis, Laura J.>I apologize for that, OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/520-0
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<v Kaddis, Laura J.>Wouldn't be a webinar without technical
issues?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/530-0
00:02:37.538 --> 00:02:39.578
<v Kaddis, Laura J.>OK. Can you?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/533-0
00:02:39.578 --> 00:02:40.618
<v Kaddis, Laura J.>I think I'm having issues.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/550-0
00:02:40.618 --> 00:02:44.437
<v Kaddis, Laura J.>I'm gonna turn my camera off, 'cause.
My mouse is lagging and I'm clicking on</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/550-1
00:02:44.437 --> 00:02:47.178
<v Kaddis, Laura J.>random things, so I'm gonna turn that off.
I apologize.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/551-0
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<v Permana, Paskasari A.>No worries.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/563-0
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<v Kaddis, Laura J.>Try to save some bandwidth and not anchor
the the team's gods, OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/570-0
00:02:54.248 --> 00:02:54.928
<v Permana, Paskasari A.>Yes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/568-0
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<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/571-0
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<v Kaddis, Laura J.>How's that look?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/574-0
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<v Permana, Paskasari A.>That looks great.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/580-0
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<v Kaddis, Laura J.>Great. Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/599-0
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<v Kaddis, Laura J.>Sorry about that all. So as possible said,
I'm Laura Kadis,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/599-1
00:03:01.991 --> 00:03:05.958
<v Kaddis, Laura J.>or those who don't know me.
I am ords research agreements manager.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/633-0
00:03:06.318 --> 00:03:11.401
<v Kaddis, Laura J.>Today we are going to discuss a new
there's MTA and Dua Ord Review Board and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/633-1
00:03:11.401 --> 00:03:15.758
<v Kaddis, Laura J.>a couple of recently published research,
Dua reference documents.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/635-0
00:03:15.758 --> 00:03:17.158
<v Kaddis, Laura J.>Thank you for joining us today.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/648-0
00:03:21.058 --> 00:03:24.218
<v Kaddis, Laura J.>All right.
If I can get this to go to the next slide.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/652-0
00:03:24.218 --> 00:03:25.338
<v Kaddis, Laura J.>All right, here we go.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/688-0
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<v Kaddis, Laura J.>Alright,
so specifically for the review board,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/688-1
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<v Kaddis, Laura J.>I will discuss an overview of the board,
a demonstration of submitting to the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/688-2
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<v Kaddis, Laura J.>board and ords responses and some
frequently asked questions that arose as</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/688-3
00:03:36.524 --> 00:03:38.658
<v Kaddis, Laura J.>part of our pilot program of the board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/711-0
00:03:40.138 --> 00:03:44.322
<v Kaddis, Laura J.>Then I will discuss our new DUA reference
documents that include adua decision tree</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/711-1
00:03:44.322 --> 00:03:47.658
<v Kaddis, Laura J.>and a quick reference guide or what I'm
calling a DUA CHEAT SHEET.</v>

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00:03:49.688 --> 00:03:51.986
<v Kaddis, Laura J.>And at the end,
we'll have some time for questions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/725-1
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<v Kaddis, Laura J.>which I will do my best to answer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/755-0
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<v Kaddis, Laura J.>All right,
so the new bares workspace for MTA and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/755-1
00:04:00.377 --> 00:04:04.493
<v Kaddis, Laura J.>DUA review requests.
It is titled VAORDDUA and MTA reviews</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/755-2
00:04:04.493 --> 00:04:05.888
<v Kaddis, Laura J.>Washington DCI know.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/760-0
00:04:06.488 --> 00:04:07.488
<v Kaddis, Laura J.>It's very long.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/769-0
00:04:07.488 --> 00:04:10.388
<v Kaddis, Laura J.>Hopefully that'll help you find it more,
find it better and maybe remember it</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/769-1
00:04:10.388 --> 00:04:10.648
<v Kaddis, Laura J.>better.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/772-0
00:04:12.458 --> 00:04:13.778
<v Kaddis, Laura J.>All right.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/776-0
00:04:13.778 --> 00:04:14.658
<v Kaddis, Laura J.>So or who, what, when and where?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/799-0
00:04:16.298 --> 00:04:22.476
<v Kaddis, Laura J.>So our VA facilities engage in research,
will submit new requests for Ord review</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/799-1
00:04:22.476 --> 00:04:24.458
<v Kaddis, Laura J.>of research, MTA and DUAS.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/843-0
00:04:25.968 --> 00:04:30.554
<v Kaddis, Laura J.>Board was launched earlier this week,
so we're able to start using it,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/843-1
00:04:30.554 --> 00:04:35.399
<v Kaddis, Laura J.>but all sites who are requesting Ord
review of these agreements must start</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/843-2
00:04:35.399 --> 00:04:40.824
<v Kaddis, Laura J.>using it by January 1st, 2026. And again,
you'll submit in bears using your your VA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/843-3
00:04:40.824 --> 00:04:41.728
<v Kaddis, Laura J.>Bears account.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/867-0
00:04:42.248 --> 00:04:45.364
<v Kaddis, Laura J.>I just want to note.
So if I'm currently working with you on</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/867-1
00:04:45.364 --> 00:04:48.326
<v Kaddis, Laura J.>an MTA or DUI over e-mail,
up now up through January 1st,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/867-2
00:04:48.326 --> 00:04:50.368
<v Kaddis, Laura J.>please continue that conversation there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/875-0
00:04:51.098 --> 00:04:53.338
<v Kaddis, Laura J.>Don't submit it to the board just so
there isn't any confusion.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/890-0
00:04:56.738 --> 00:04:59.117
<v Kaddis, Laura J.>And the most important W is the Y.
Of course,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/890-1
00:04:59.117 --> 00:05:00.978
<v Kaddis, Laura J.>we've had so many changes this year.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/891-0
00:05:00.978 --> 00:05:01.018
<v Kaddis, Laura J.>Y.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/892-0
00:05:01.018 --> 00:05:02.258
<v Kaddis, Laura J.>Another one.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/897-0
00:05:02.378 --> 00:05:03.898
<v Kaddis, Laura J.>Well, a few reasons.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/930-0
00:05:04.338 --> 00:05:07.106
<v Kaddis, Laura J.>First,
many sites already use theirs to manage</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/930-1
00:05:07.106 --> 00:05:10.581
<v Kaddis, Laura J.>these agreements,
so being able to complete the Ord review</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/930-2
00:05:10.581 --> 00:05:15.351
<v Kaddis, Laura J.>within various will allow them to keep
the whole execution process in the system</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/930-3
00:05:15.351 --> 00:05:19.178
<v Kaddis, Laura J.>without having to jump back and forth
between irbnat and e-mail.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/952-0
00:05:21.448 --> 00:05:25.475
<v Kaddis, Laura J.>It also helps to streamline the process.
Gives all of our inboxes a break if we</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/952-1
00:05:25.475 --> 00:05:28.344
<v Kaddis, Laura J.>can just submit these packages back and
forth on theirs,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/952-2
00:05:28.344 --> 00:05:30.608
<v Kaddis, Laura J.>then there will be less emails for
everyone.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/993-0
00:05:32.798 --> 00:05:37.075
<v Kaddis, Laura J.>It also improves records keeping so every
iteration of the agreement,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/993-1
00:05:37.075 --> 00:05:40.130
<v Kaddis, Laura J.>every negotiation round between Ord and
the site,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/993-2
00:05:40.130 --> 00:05:44.835
<v Kaddis, Laura J.>any conversations that they had with
their the non VA entity that show up in</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/993-3
00:05:44.835 --> 00:05:49.478
<v Kaddis, Laura J.>the agreements will be able to get figure
out how we got from version A to.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1008-0
00:05:49.478 --> 00:05:52.135
<v Kaddis, Laura J.>Version Z.
If in case there's an issue and we need</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1008-1
00:05:52.135 --> 00:05:53.958
<v Kaddis, Laura J.>to figure out why we did something.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1017-0
00:05:56.168 --> 00:05:58.128
<v Kaddis, Laura J.>And finally, it ensures continuity.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1045-0
00:05:58.128 --> 00:06:02.956
<v Kaddis, Laura J.>So if I ever win the lottery,
or what's more likely in Baltimore,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1045-1
00:06:02.956 --> 00:06:07.929
<v Kaddis, Laura J.>get hit by a city bus. My way,
in my Orde colleagues can access the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1045-2
00:06:07.929 --> 00:06:08.368
<v Kaddis, Laura J.>board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1069-0
00:06:08.368 --> 00:06:10.496
<v Kaddis, Laura J.>See exactly what agreements I'm working
on.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1069-1
00:06:10.496 --> 00:06:14.461
<v Kaddis, Laura J.>The status of those agreements and what
needs to be done so that you are not left</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1069-2
00:06:14.461 --> 00:06:14.848
<v Kaddis, Laura J.>hanging.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1088-0
00:06:15.448 --> 00:06:20.267
<v Kaddis, Laura J.>I just want to emphasize the only only
change to the Ord review process of</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1088-1
00:06:20.267 --> 00:06:23.928
<v Kaddis, Laura J.>research duas and Mtas is how the
agreements get to Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1093-0
00:06:24.578 --> 00:06:26.738
<v Kaddis, Laura J.>Nothing else is changing about how.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1096-0
00:06:26.928 --> 00:06:27.808
<v Kaddis, Laura J.>The how?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1114-0
00:06:27.808 --> 00:06:31.918
<v Kaddis, Laura J.>The review will go which agreements need
to come to to Ord nothing else,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1114-1
00:06:31.918 --> 00:06:33.888
<v Kaddis, Laura J.>just how they are submitted to Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1151-0
00:06:36.368 --> 00:06:41.730
<v Kaddis, Laura J.>And our bonus H the how? As always,
I'd like to stress Ord does not review</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1151-1
00:06:41.730 --> 00:06:45.590
<v Kaddis, Laura J.>all of research,
MTA's and duas your research office.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1151-2
00:06:45.590 --> 00:06:50.808
<v Kaddis, Laura J.>Or if you have another local research
agreements authority. I know some.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1156-0
00:06:50.848 --> 00:06:51.728
<v Kaddis, Laura J.>Sometimes it's the RDC.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1172-0
00:06:51.728 --> 00:06:54.883
<v Kaddis, Laura J.>Sometimes there's an individual subject
matter expert,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1172-1
00:06:54.883 --> 00:06:59.128
<v Kaddis, Laura J.>whoever that is at your facility,
they should first review the agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1186-0
00:07:00.618 --> 00:07:05.338
<v Kaddis, Laura J.>If they identify any potential policy,
intellectual property or legal issues.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1197-0
00:07:05.768 --> 00:07:08.048
<v Kaddis, Laura J.>That can't be resolved at the site level.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1200-0
00:07:08.168 --> 00:07:10.608
<v Kaddis, Laura J.>Those agreements can come to Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1219-0
00:07:13.008 --> 00:07:16.821
<v Kaddis, Laura J.>As far as who submits the agreement in
theirs, it really can be anyone.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1219-1
00:07:16.821 --> 00:07:18.568
<v Kaddis, Laura J.>Your facility can determine this.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1231-0
00:07:18.568 --> 00:07:22.648
<v Kaddis, Laura J.>It can be the Pi research Coordinator and
other research team member.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1245-0
00:07:22.728 --> 00:07:26.552
<v Kaddis, Laura J.>It should be someone who's familiar
enough with the agreement and the project</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1245-1
00:07:26.552 --> 00:07:27.728
<v Kaddis, Laura J.>to answer Ord questions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1246-0
00:07:27.728 --> 00:07:28.568
<v Kaddis, Laura J.>That's all I ask.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1273-0
00:07:30.218 --> 00:07:34.927
<v Kaddis, Laura J.>So whoever the submitter is using their
VA var's account will submit a new</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1273-1
00:07:34.927 --> 00:07:39.825
<v Kaddis, Laura J.>package in the project that includes the
redline agreement and the MTA or DUA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1273-2
00:07:39.825 --> 00:07:40.578
<v Kaddis, Laura J.>intake form.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1298-0
00:07:41.278 --> 00:07:45.779
<v Kaddis, Laura J.>And I will touch on those intake forms on
the next slide if your project is not</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1298-1
00:07:45.779 --> 00:07:49.267
<v Kaddis, Laura J.>already in there. So say maybe it's an,
it's an animal study,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1298-2
00:07:49.267 --> 00:07:51.798
<v Kaddis, Laura J.>you will need to still create a new
project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1306-0
00:07:51.878 --> 00:07:53.438
<v Kaddis, Laura J.>It's very simple to do.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1312-0
00:07:53.478 --> 00:07:56.558
<v Kaddis, Laura J.>There is University is a great,
great resource for this.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1335-0
00:07:56.558 --> 00:08:00.384
<v Kaddis, Laura J.>I'd like to it later in this in these
slides to be able to access it that way</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1335-1
00:08:00.384 --> 00:08:03.278
<v Kaddis, Laura J.>step by step videos,
PowerPoints and how to do everything.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1348-0
00:08:03.278 --> 00:08:06.606
<v Kaddis, Laura J.>It's also just very easy to create a new
project, so don't stress.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1348-1
00:08:06.606 --> 00:08:07.798
<v Kaddis, Laura J.>It's easy to figure out.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1364-0
00:08:10.008 --> 00:08:13.139
<v Kaddis, Laura J.>Alright,
so I've talked about the DUI intake forms</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1364-1
00:08:13.139 --> 00:08:13.568
<v Kaddis, Laura J.>before.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1387-0
00:08:13.648 --> 00:08:17.840
<v Kaddis, Laura J.>We've been using them for over a year now,
so I know a ton of you are probably</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1387-1
00:08:17.840 --> 00:08:21.448
<v Kaddis, Laura J.>already familiar with them,
but I do just want to recap real quick.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1399-0
00:08:22.018 --> 00:08:26.382
<v Kaddis, Laura J.>So the intake forms is a short form.
It should take less than 10 minutes to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1399-1
00:08:26.382 --> 00:08:26.898
<v Kaddis, Laura J.>complete.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1434-0
00:08:27.178 --> 00:08:32.085
<v Kaddis, Laura J.>It contains information that we need for
Ord review and it must accompany any</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1434-1
00:08:32.085 --> 00:08:36.237
<v Kaddis, Laura J.>request for Ord review.
If the package you submit for the initial</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1434-2
00:08:36.237 --> 00:08:41.018
<v Kaddis, Laura J.>review of request does not have an intake
form, I will kick it back to you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1450-0
00:08:41.058 --> 00:08:44.585
<v Kaddis, Laura J.>You can access the forms in the Bears
forms and templates library and I'll show</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1450-1
00:08:44.585 --> 00:08:45.378
<v Kaddis, Laura J.>you that in a bit.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1454-0
00:08:46.298 --> 00:08:48.858
<v Kaddis, Laura J.>So the first question on both the DUI and.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1463-0
00:08:49.608 --> 00:08:52.728
<v Kaddis, Laura J.>MTA intake forms is is the research
office aware of this consultation?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1473-0
00:08:53.238 --> 00:08:56.518
<v Kaddis, Laura J.>Your request that is probably the number
one most important question on the form.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1481-0
00:08:56.518 --> 00:08:58.678
<v Kaddis, Laura J.>That's why it's the number one question
on the forum.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1499-0
00:08:58.958 --> 00:09:02.196
<v Kaddis, Laura J.>Again, if this says,
if your answer says no Ord will kick the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1499-1
00:09:02.196 --> 00:09:06.478
<v Kaddis, Laura J.>agreement back and send you back to your
research office or agreements authority.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1522-0
00:09:06.638 --> 00:09:11.730
<v Kaddis, Laura J.>You should not submit an MTI or DUA for
Ord review unless directed by that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1522-1
00:09:11.730 --> 00:09:14.038
<v Kaddis, Laura J.>agreement's authority and for DUA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1533-0
00:09:14.038 --> 00:09:17.572
<v Kaddis, Laura J.>So here this is a screenshot of some of
the first questions of the DUA intake</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1533-1
00:09:17.572 --> 00:09:17.798
<v Kaddis, Laura J.>form.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1544-0
00:09:18.528 --> 00:09:21.885
<v Kaddis, Laura J.>You can see the second question has the
Privacy Officer been consulted and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1544-1
00:09:21.885 --> 00:09:22.288
<v Kaddis, Laura J.>approved?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1566-0
00:09:22.678 --> 00:09:26.110
<v Kaddis, Laura J.>The data or sorry yeah,
been consulted and approved the data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1566-1
00:09:26.110 --> 00:09:29.428
<v Kaddis, Laura J.>transfer request.
If that is no again I will kick back the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1566-2
00:09:29.428 --> 00:09:29.878
<v Kaddis, Laura J.>request.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1577-0
00:09:30.278 --> 00:09:32.523
<v Kaddis, Laura J.>It's not necessarily that they have to
review the DUA,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1577-1
00:09:32.523 --> 00:09:34.318
<v Kaddis, Laura J.>but they have to review the actual
request.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1589-0
00:09:34.638 --> 00:09:37.029
<v Kaddis, Laura J.>Why?
Because this saves everyone a headache</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1589-1
00:09:37.029 --> 00:09:38.278
<v Kaddis, Laura J.>and unnecessary effort.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1613-0
00:09:38.398 --> 00:09:43.150
<v Kaddis, Laura J.>It's important to confirm ahead of time,
one that the privacy authority for the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1613-1
00:09:43.150 --> 00:09:46.476
<v Kaddis, Laura J.>data transfer,
if there's anything being disclosed that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1613-2
00:09:46.476 --> 00:09:48.198
<v Kaddis, Laura J.>the Privacy authority exists.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1622-0
00:09:48.928 --> 00:09:50.408
<v Kaddis, Laura J.>And two, the type of data involved.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1626-0
00:09:50.408 --> 00:09:52.368
<v Kaddis, Laura J.>This will affect the type of DUI used.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1656-0
00:09:55.618 --> 00:09:58.046
<v Kaddis, Laura J.>OK,
getting back to the board and a look at</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1656-1
00:09:58.046 --> 00:10:01.963
<v Kaddis, Laura J.>the review process once submitted.
So again the site will submit a new</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1656-2
00:10:01.963 --> 00:10:05.218
<v Kaddis, Laura J.>package in the project with the agreement
and intake form.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1672-0
00:10:06.688 --> 00:10:09.808
<v Kaddis, Laura J.>As always,
Ord will review and coordinate any other</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1672-1
00:10:09.808 --> 00:10:11.728
<v Kaddis, Laura J.>reviews with their legal issues.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1694-0
00:10:11.768 --> 00:10:15.768
<v Kaddis, Laura J.>I'll coordinate reviews with OGC Star.
If there's anything of potential</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1694-1
00:10:15.768 --> 00:10:18.768
<v Kaddis, Laura J.>intellectual property issues then I will
contact TTP.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1707-0
00:10:19.488 --> 00:10:21.953
<v Kaddis, Laura J.>Again,
this has not changed from the previous</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1707-1
00:10:21.953 --> 00:10:24.579
<v Kaddis, Laura J.>process.
The only change is how these agreements</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1707-2
00:10:24.579 --> 00:10:25.168
<v Kaddis, Laura J.>get to Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1729-0
00:10:27.008 --> 00:10:29.554
<v Kaddis, Laura J.>Once all of the necessary reviews are
complete,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1729-1
00:10:29.554 --> 00:10:34.008
<v Kaddis, Laura J.>Ord will return the agreement as a board
document and note what actions are needed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1738-0
00:10:34.088 --> 00:10:36.903
<v Kaddis, Laura J.>It might sound weird,
but once once I do a demonstration,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1738-1
00:10:36.903 --> 00:10:37.728
<v Kaddis, Laura J.>it'll make sense.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1791-0
00:10:40.578 --> 00:10:44.096
<v Kaddis, Laura J.>So if changes are needed,
please address the comments and then</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1791-1
00:10:44.096 --> 00:10:47.222
<v Kaddis, Laura J.>resubmit the revised document as part of
a new package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1791-2
00:10:47.222 --> 00:10:50.684
<v Kaddis, Laura J.>If you have questions while you're
addressing those comments,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1791-3
00:10:50.684 --> 00:10:53.922
<v Kaddis, Laura J.>you can contact our DV of theirs mail or
just e-mail Ord,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1791-4
00:10:53.922 --> 00:10:57.048
<v Kaddis, Laura J.>central policy and regulatory with the
various package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1795-0
00:10:57.048 --> 00:10:58.258
<v Kaddis, Laura J.>Number at that e-mail below.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1830-0
00:11:00.618 --> 00:11:04.380
<v Kaddis, Laura J.>If no changes are needed,
you'll see that the note it's sorry that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1830-1
00:11:04.380 --> 00:11:08.534
<v Kaddis, Laura J.>the note states to route the agreement
for signatures per your facilities</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1830-2
00:11:08.534 --> 00:11:12.745
<v Kaddis, Laura J.>processes. Once that is complete,
please submit an executed agreement as a</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1830-3
00:11:12.745 --> 00:11:13.418
<v Kaddis, Laura J.>new package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1862-0
00:11:13.418 --> 00:11:17.157
<v Kaddis, Laura J.>I want to copy that final agreement so
that we know when the agreements are</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1862-1
00:11:17.157 --> 00:11:20.354
<v Kaddis, Laura J.>getting done and just that everyone had
was agreed on the final,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1862-2
00:11:20.354 --> 00:11:23.453
<v Kaddis, Laura J.>the final agreement and I know I just
said agreement 20 times.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1862-3
00:11:23.453 --> 00:11:24.338
<v Kaddis, Laura J.>But that's my job.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1876-0
00:11:26.368 --> 00:11:29.408
<v Kaddis, Laura J.>All right, so as I said,
there are detailed written instructions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1882-0
00:11:29.408 --> 00:11:31.604
<v Kaddis, Laura J.>Maybe I didn't say that so,
but there are detailed written</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1882-1
00:11:31.604 --> 00:11:32.088
<v Kaddis, Laura J.>instructions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1928-0
00:11:32.438 --> 00:11:37.252
<v Kaddis, Laura J.>On the submission process in Fine Pro,
and I do link to those later in this as</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1928-1
00:11:37.252 --> 00:11:40.055
<v Kaddis, Laura J.>well,
but I'd also like to show some examples</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1928-2
00:11:40.055 --> 00:11:42.858
<v Kaddis, Laura J.>of submitting to the board and Ords
response,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1928-3
00:11:42.858 --> 00:11:46.758
<v Kaddis, Laura J.>so I'm going to switch over to irbnet let
me stop sharing this.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1935-0
00:11:48.288 --> 00:11:50.768
<v Kaddis, Laura J.>Please give me a moment as I transfer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1938-0
00:12:01.668 --> 00:12:01.948
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1955-0
00:12:01.948 --> 00:12:05.404
<v Kaddis, Laura J.>Can someone just give me a thumbs up if
that's large enough for whether I should</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1955-1
00:12:05.404 --> 00:12:06.428
<v Kaddis, Laura J.>zoom in a little closer?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1959-0
00:12:08.358 --> 00:12:09.558
<v Kaddis, Laura J.>OK, cool. Thank you so.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1967-0
00:12:11.088 --> 00:12:13.248
<v Kaddis, Laura J.>I'm going to sign into a researcher's
account.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1969-0
00:12:15.518 --> 00:12:16.678
<v Kaddis, Laura J.>As an example.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1981-0
00:12:17.718 --> 00:12:20.838
<v Kaddis, Laura J.>Alright, so once I sign in,
you'll I'll see as the researcher.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/1986-0
00:12:20.838 --> 00:12:22.558
<v Kaddis, Laura J.>I'll see my projects here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2007-0
00:12:22.558 --> 00:12:27.671
<v Kaddis, Laura J.>This is the IRB net account of Clare
researcher who has submitted various</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2007-1
00:12:27.671 --> 00:12:30.918
<v Kaddis, Laura J.>packages for Doctor Jane Doe for her
research.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2047-0
00:12:31.478 --> 00:12:35.861
<v Kaddis, Laura J.>So the very first thing I wanna show you
is the forms and templates library where</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2047-1
00:12:35.861 --> 00:12:39.388
<v Kaddis, Laura J.>you can find some of the relevant
agreements or or the documents.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2047-2
00:12:39.388 --> 00:12:42.862
<v Kaddis, Laura J.>I've already spoken about.
So on the left here under other tools</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2047-3
00:12:42.862 --> 00:12:44.198
<v Kaddis, Laura J.>just forms and templates.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2051-0
00:12:45.288 --> 00:12:46.808
<v Kaddis, Laura J.>When you select a library.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2076-0
00:12:47.278 --> 00:12:50.162
<v Kaddis, Laura J.>In your count,
there will likely be many more just in</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2076-1
00:12:50.162 --> 00:12:53.527
<v Kaddis, Laura J.>this training account,
we will Scroll down to the VAORDDUA and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2076-2
00:12:53.527 --> 00:12:57.318
<v Kaddis, Laura J.>MTA Reviews library that will be called
the same in your list as well.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2111-0
00:12:59.278 --> 00:13:02.960
<v Kaddis, Laura J.>So you see here you can access the DUA
and MTA intake forms.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2111-1
00:13:02.960 --> 00:13:06.944
<v Kaddis, Laura J.>The research dua template.
So the DE identified data limited data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2111-2
00:13:06.944 --> 00:13:11.169
<v Kaddis, Laura J.>set and Phi for use when the BA is
providing data and instructions to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2111-3
00:13:11.169 --> 00:13:12.678
<v Kaddis, Laura J.>complete those templates.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2133-0
00:13:12.838 --> 00:13:15.658
<v Kaddis, Laura J.>Also,
the detailed instructions for submitting</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2133-1
00:13:15.658 --> 00:13:20.398
<v Kaddis, Laura J.>MTA's and Duas in theirs and accompanying
lists of frequently asked questions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2157-0
00:13:21.318 --> 00:13:24.881
<v Kaddis, Laura J.>So once you're once an,
if your research office determines that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2157-1
00:13:24.881 --> 00:13:28.388
<v Kaddis, Laura J.>Ord review is needed,
you'll download the relevant intake form</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2157-2
00:13:28.388 --> 00:13:29.278
<v Kaddis, Laura J.>and complete it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2161-0
00:13:29.948 --> 00:13:31.908
<v Kaddis, Laura J.>Which will accompany your package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2179-0
00:13:33.368 --> 00:13:38.168
<v Kaddis, Laura J.>So I first want to show you how to submit
an initial request for Ord review.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2196-0
00:13:38.728 --> 00:13:42.658
<v Kaddis, Laura J.>So let's check out Doctor Doe's very
important project here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2196-1
00:13:42.658 --> 00:13:46.008
<v Kaddis, Laura J.>Quantifying this required to access
Tootsipop core.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2200-0
00:13:46.048 --> 00:13:47.168
<v Kaddis, Laura J.>Again, very important.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2225-0
00:13:47.848 --> 00:13:52.949
<v Kaddis, Laura J.>So once you access your project overview
in order to I know I have worked very</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2225-1
00:13:52.949 --> 00:13:56.435
<v Kaddis, Laura J.>hard on that,
probably too hard in order to access in</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2225-2
00:13:56.435 --> 00:13:58.888
<v Kaddis, Laura J.>order to create a new project package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2235-0
00:13:59.558 --> 00:14:02.955
<v Kaddis, Laura J.>You'll go on the left here under project
administration. The very bottom.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2235-1
00:14:02.955 --> 00:14:03.918
<v Kaddis, Laura J.>Create a new package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2241-0
00:14:05.688 --> 00:14:07.968
<v Kaddis, Laura J.>And then you will attach new document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2286-0
00:14:11.168 --> 00:14:16.275
<v Kaddis, Laura J.>I don't know if you can see my pop up
that lets me select my documents here as</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2286-1
00:14:16.275 --> 00:14:20.218
<v Kaddis, Laura J.>I'm sharing my screen,
but you'll you will select the intake</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2286-2
00:14:20.218 --> 00:14:24.613
<v Kaddis, Laura J.>form and a word version of the agreement
and it should be redlined.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2286-3
00:14:24.613 --> 00:14:27.328
<v Kaddis, Laura J.>Any changes to the agreement should be in.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2291-0
00:14:27.328 --> 00:14:28.528
<v Kaddis, Laura J.>Redline, not counting the.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2298-0
00:14:28.718 --> 00:14:31.598
<v Kaddis, Laura J.>The fillable fields,
the yellow and green highlights.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2314-0
00:14:32.878 --> 00:14:36.968
<v Kaddis, Laura J.>For document type please select other.
It really isn't anything else fitting,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2314-1
00:14:36.968 --> 00:14:38.278
<v Kaddis, Laura J.>so just select other for.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2322-0
00:14:39.728 --> 00:14:41.768
<v Kaddis, Laura J.>This and that is all you need for this
package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2336-0
00:14:41.808 --> 00:14:46.128
<v Kaddis, Laura J.>So then you'll come back over to the left
here, under project administration.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2337-0
00:14:46.168 --> 00:14:48.608
<v Kaddis, Laura J.>About Midway submit this package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2371-0
00:14:51.938 --> 00:14:56.987
<v Kaddis, Laura J.>Now to find the correct board you need to
deselect only show my default boards and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2371-1
00:14:56.987 --> 00:15:01.731
<v Kaddis, Laura J.>then if you just search MTA it will bring
up the board you're looking for the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2371-2
00:15:01.731 --> 00:15:05.258
<v Kaddis, Laura J.>review board. So just select that board,
select continue.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2378-0
00:15:06.848 --> 00:15:07.448
<v Kaddis, Laura J.>Are you sure?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2381-0
00:15:07.448 --> 00:15:08.648
<v Kaddis, Laura J.>Yes, OK, submission type.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2393-0
00:15:08.648 --> 00:15:12.202
<v Kaddis, Laura J.>This is a new a request for a new review
of a new agreement,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2393-1
00:15:12.202 --> 00:15:14.008
<v Kaddis, Laura J.>so please select new agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2409-0
00:15:14.448 --> 00:15:17.879
<v Kaddis, Laura J.>You don't need to enter any comments if
there is anything you want to communicate</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2409-1
00:15:17.879 --> 00:15:19.804
<v Kaddis, Laura J.>or do.
There's a specific section that you're</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2409-2
00:15:19.804 --> 00:15:20.808
<v Kaddis, Laura J.>just like, I don't know.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2415-0
00:15:21.158 --> 00:15:21.918
<v Kaddis, Laura J.>What to do with this?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2418-0
00:15:21.918 --> 00:15:22.558
<v Kaddis, Laura J.>It's kind of funky.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2423-0
00:15:22.558 --> 00:15:24.798
<v Kaddis, Laura J.>Please feel free to add comments in there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2426-0
00:15:24.798 --> 00:15:25.878
<v Kaddis, Laura J.>But you don't have to add anything.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2440-0
00:15:28.548 --> 00:15:32.668
<v Kaddis, Laura J.>OK. And then once submitted,
it goes straight to the Ord group.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2443-0
00:15:33.028 --> 00:15:33.948
<v Kaddis, Laura J.>I am the group right now.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2450-0
00:15:33.948 --> 00:15:35.748
<v Kaddis, Laura J.>I'll go straight to Ord for review.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2454-0
00:15:35.788 --> 00:15:37.668
<v Kaddis, Laura J.>So again, super simple.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2470-0
00:15:37.988 --> 00:15:41.733
<v Kaddis, Laura J.>So now I want to show you what happens
once Ord reviews and they find that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2470-1
00:15:41.733 --> 00:15:44.428
<v Kaddis, Laura J.>modifications are needed and send the
agreement back.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2473-0
00:15:44.908 --> 00:15:46.428
<v Kaddis, Laura J.>We'll check out another project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2489-0
00:15:49.358 --> 00:15:53.546
<v Kaddis, Laura J.>Assessing Woodchuck woodchucking
abilities and limits. Again, I'm so sorry.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2489-1
00:15:53.546 --> 00:15:54.758
<v Kaddis, Laura J.>I spent a lot of time.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2492-0
00:15:54.758 --> 00:15:56.238
<v Kaddis, Laura J.>There's probably too much time on this.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2532-0
00:15:57.848 --> 00:16:03.625
<v Kaddis, Laura J.>So for this Clare researcher has already
submitted the initial package to Ord,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2532-1
00:16:03.625 --> 00:16:06.916
<v Kaddis, Laura J.>has reviewed and has returned the
agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2532-2
00:16:06.916 --> 00:16:12.181
<v Kaddis, Laura J.>So down you'll see here the package is
here and the board action states</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2532-3
00:16:12.181 --> 00:16:16.568
<v Kaddis, Laura J.>modifications are required.
If you click on review details.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2538-0
00:16:18.128 --> 00:16:19.968
<v Kaddis, Laura J.>You will be able to see the board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2552-0
00:16:20.318 --> 00:16:22.593
<v Kaddis, Laura J.>Document so here I won't.
I won't download it,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2552-1
00:16:22.593 --> 00:16:24.238
<v Kaddis, Laura J.>so it might slow down my computer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2570-0
00:16:24.238 --> 00:16:26.862
<v Kaddis, Laura J.>So here if you click on the document
under view,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2570-1
00:16:26.862 --> 00:16:30.718
<v Kaddis, Laura J.>it'll download the Word document that has
ords comments embedded in it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2588-0
00:16:31.358 --> 00:16:35.765
<v Kaddis, Laura J.>So you will read those comments again if
you have any questions you can contact</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2588-1
00:16:35.765 --> 00:16:37.638
<v Kaddis, Laura J.>Ord via project mail or just over.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2589-0
00:16:37.638 --> 00:16:38.718
<v Kaddis, Laura J.>E-mail is fine.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2605-0
00:16:39.238 --> 00:16:43.325
<v Kaddis, Laura J.>So you'll address the comments and then
once you are done with the revised</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2605-1
00:16:43.325 --> 00:16:46.158
<v Kaddis, Laura J.>document, again,
you'll come over to the left here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2609-0
00:16:47.048 --> 00:16:48.488
<v Kaddis, Laura J.>Create a new package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2618-0
00:16:49.858 --> 00:16:52.378
<v Kaddis, Laura J.>Attach new document just like the initial
submission.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2624-0
00:16:58.928 --> 00:17:00.128
<v Kaddis, Laura J.>And that is all you would need.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2637-0
00:17:00.128 --> 00:17:03.369
<v Kaddis, Laura J.>Well, let me sorry.
Let me put other for type of document and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2637-1
00:17:03.369 --> 00:17:04.728
<v Kaddis, Laura J.>then that is all you need.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2654-0
00:17:04.808 --> 00:17:08.125
<v Kaddis, Laura J.>You don't need to submit the intake form
for any of the subsequent packages,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2654-1
00:17:08.125 --> 00:17:09.288
<v Kaddis, Laura J.>just the initial agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2668-0
00:17:09.848 --> 00:17:13.477
<v Kaddis, Laura J.>So then again back over to project
administration on the left,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2668-1
00:17:13.477 --> 00:17:15.608
<v Kaddis, Laura J.>halfway down and submit this package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2676-0
00:17:17.248 --> 00:17:19.528
<v Kaddis, Laura J.>Find the Ord du 8 MTA review board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2707-0
00:17:22.618 --> 00:17:25.793
<v Kaddis, Laura J.>So now this is a response to Ords initial
review,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2707-1
00:17:25.793 --> 00:17:30.744
<v Kaddis, Laura J.>so please select response and follow up
if you have any comments feel free to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2707-2
00:17:30.744 --> 00:17:32.458
<v Kaddis, Laura J.>enter them and then submit.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2710-0
00:17:32.578 --> 00:17:33.698
<v Kaddis, Laura J.>So simple as that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2726-0
00:17:34.378 --> 00:17:39.238
<v Kaddis, Laura J.>So now moving on to what happens once Ord
reviews and determines that no changes</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2726-1
00:17:39.238 --> 00:17:39.898
<v Kaddis, Laura J.>are needed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2732-0
00:17:42.398 --> 00:17:44.718
<v Kaddis, Laura J.>So next package, next project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2739-0
00:17:44.718 --> 00:17:47.464
<v Kaddis, Laura J.>Sorry,
effects of Rose name on sweetness of</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2739-1
00:17:47.464 --> 00:17:47.838
<v Kaddis, Laura J.>smell.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2769-0
00:17:49.448 --> 00:17:52.860
<v Kaddis, Laura J.>So for this project,
clear researcher has already submitted</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2769-1
00:17:52.860 --> 00:17:57.068
<v Kaddis, Laura J.>their initial review to Ord received
request to make modifications, made.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2769-2
00:17:57.068 --> 00:17:59.968
<v Kaddis, Laura J.>Those modifications,
resubmitted them in an ordin.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2785-0
00:18:01.648 --> 00:18:06.495
<v Kaddis, Laura J.>Ance were needed so here for this package.
The board action is going to state review</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2785-1
00:18:06.495 --> 00:18:07.008
<v Kaddis, Laura J.>complete.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2793-0
00:18:07.688 --> 00:18:10.858
<v Kaddis, Laura J.>So again,
if you select review details you will see</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2793-1
00:18:10.858 --> 00:18:11.528
<v Kaddis, Laura J.>there is a.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2795-0
00:18:12.358 --> 00:18:12.398
<v Kaddis, Laura J.>A.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2800-0
00:18:12.398 --> 00:18:14.438
<v Kaddis, Laura J.>Board a board document here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2808-0
00:18:14.478 --> 00:18:16.958
<v Kaddis, Laura J.>The description states no changes needed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2826-0
00:18:16.958 --> 00:18:21.303
<v Kaddis, Laura J.>Route for signatures and submit a copy of
the signed DUA as a new package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2826-1
00:18:21.303 --> 00:18:23.678
<v Kaddis, Laura J.>So you will download that board document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2854-0
00:18:24.288 --> 00:18:28.015
<v Kaddis, Laura J.>Likely, if there were no changes needed,
it'll probably be exactly the same as you</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2854-1
00:18:28.015 --> 00:18:30.035
<v Kaddis, Laura J.>submitted.
If there were some small changes,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2854-2
00:18:30.035 --> 00:18:32.728
<v Kaddis, Laura J.>maybe some formatting things,
or you may have changed that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2865-0
00:18:32.728 --> 00:18:36.128
<v Kaddis, Laura J.>So please just download from the board
documents and use that one.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2866-0
00:18:36.168 --> 00:18:36.768
<v Kaddis, Laura J.>Clean it up.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2886-0
00:18:36.768 --> 00:18:39.887
<v Kaddis, Laura J.>Just accept all the changes,
remove the document, or sorry,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2886-1
00:18:39.887 --> 00:18:43.889
<v Kaddis, Laura J.>remove the comments and then circulate it
for signatures per your facilities</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2886-2
00:18:43.889 --> 00:18:44.408
<v Kaddis, Laura J.>processes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2903-0
00:18:45.918 --> 00:18:48.685
<v Kaddis, Laura J.>Alright,
so once we do that so once let's say skip</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2903-1
00:18:48.685 --> 00:18:50.638
<v Kaddis, Laura J.>ahead, we got all of our signatures.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2912-0
00:18:50.678 --> 00:18:53.518
<v Kaddis, Laura J.>So again, we will go to new projects.
We want to submit.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2923-0
00:18:53.908 --> 00:18:56.348
<v Kaddis, Laura J.>A fully executed version for records
purposes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2925-0
00:18:56.348 --> 00:18:58.308
<v Kaddis, Laura J.>So new project on the side.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2928-0
00:18:59.838 --> 00:19:01.158
<v Kaddis, Laura J.>Attach a new document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2944-0
00:19:03.388 --> 00:19:06.468
<v Kaddis, Laura J.>I know it's it's repetitive just because
it's it's very easy to submit.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2947-0
00:19:06.468 --> 00:19:07.508
<v Kaddis, Laura J.>It's all the same.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2952-0
00:19:07.508 --> 00:19:09.188
<v Kaddis, Laura J.>You're just submitting different
documents each time.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2975-0
00:19:10.718 --> 00:19:13.766
<v Kaddis, Laura J.>All right.
So then I selected my PDF of my executed</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2975-1
00:19:13.766 --> 00:19:17.106
<v Kaddis, Laura J.>DUI. Here again,
just select other for type of agreement</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2975-2
00:19:17.106 --> 00:19:18.278
<v Kaddis, Laura J.>or type of document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2978-0
00:19:20.158 --> 00:19:21.038
<v Kaddis, Laura J.>Submit this package.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2987-0
00:19:28.688 --> 00:19:31.808
<v Kaddis, Laura J.>And submission type will be final
executed agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2991-0
00:19:34.038 --> 00:19:34.918
<v Kaddis, Laura J.>And that's it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/2994-0
00:19:34.998 --> 00:19:36.318
<v Kaddis, Laura J.>Nothing else to do for that one.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3003-0
00:19:37.798 --> 00:19:41.238
<v Kaddis, Laura J.>So once you have submitted that final
executed agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3033-0
00:19:43.388 --> 00:19:48.800
<v Kaddis, Laura J.>As has been done for the project,
behavioral limits for Klondike bar reward,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3033-1
00:19:48.800 --> 00:19:54.212
<v Kaddis, Laura J.>you will see Ord will just look at the
agreement and the board action return</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3033-2
00:19:54.212 --> 00:19:55.828
<v Kaddis, Laura J.>will state acknowledge.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3046-0
00:19:55.908 --> 00:19:58.788
<v Kaddis, Laura J.>You can click on review details there,
but there isn't anything else.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3050-0
00:19:58.788 --> 00:20:00.028
<v Kaddis, Laura J.>There's no board document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3056-0
00:20:00.028 --> 00:20:03.028
<v Kaddis, Laura J.>There's no other actions for you to take.
That's it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3067-0
00:20:03.068 --> 00:20:05.730
<v Kaddis, Laura J.>So from start to finish your initial
submission,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3067-1
00:20:05.730 --> 00:20:08.228
<v Kaddis, Laura J.>your resubmission if there are
modifications.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3077-0
00:20:08.958 --> 00:20:13.918
<v Kaddis, Laura J.>Your receipt of the final review and then
route it for signature.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3094-0
00:20:14.068 --> 00:20:19.846
<v Kaddis, Laura J.>And then upload the final executed
agreement and receive the acknowledged</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3094-1
00:20:19.846 --> 00:20:20.548
<v Kaddis, Laura J.>from Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3098-0
00:20:21.068 --> 00:20:21.628
<v Kaddis, Laura J.>So that's it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3101-0
00:20:21.628 --> 00:20:22.548
<v Kaddis, Laura J.>It's really not.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3123-0
00:20:22.588 --> 00:20:26.169
<v Kaddis, Laura J.>Not a lot if you already use bears,
which I know, like almost all of you do.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3123-1
00:20:26.169 --> 00:20:29.285
<v Kaddis, Laura J.>If you're if you're a human research or
human subjects researcher,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3123-2
00:20:29.285 --> 00:20:30.308
<v Kaddis, Laura J.>it's it's nothing new.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3125-0
00:20:30.308 --> 00:20:32.068
<v Kaddis, Laura J.>It's just selecting a new board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3134-0
00:20:33.618 --> 00:20:34.978
<v Kaddis, Laura J.>All right. So I hope that helped.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3138-0
00:20:34.978 --> 00:20:36.858
<v Kaddis, Laura J.>I'm going to switch back to my PowerPoint.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3143-0
00:20:38.678 --> 00:20:40.318
<v Kaddis, Laura J.>Theoretically, if I can get it to work.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3147-0
00:20:44.328 --> 00:20:45.368
<v Kaddis, Laura J.>OK, cool. Here we are.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3173-0
00:20:47.798 --> 00:20:52.178
<v Kaddis, Laura J.>Maybe. OK, so as I said earlier,
so Ord is actually running a pilot test</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3173-1
00:20:52.178 --> 00:20:55.238
<v Kaddis, Laura J.>of this,
the Bears program for the Bears board for</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3173-2
00:20:55.238 --> 00:20:57.758
<v Kaddis, Laura J.>over a year with with about 10 facilities.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3184-0
00:20:57.758 --> 00:21:01.518
<v Kaddis, Laura J.>So these sites provided invaluable input
on the use of the board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3220-0
00:21:01.878 --> 00:21:05.505
<v Kaddis, Laura J.>Sorry how the board was organized and the
submission instructions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3220-1
00:21:05.505 --> 00:21:09.781
<v Kaddis, Laura J.>so I was able to make changes based on
their evaluations and really try to get</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3220-2
00:21:09.781 --> 00:21:13.678
<v Kaddis, Laura J.>this as easy and and like streamlined as
possible for our sites to use.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3223-0
00:21:14.228 --> 00:21:15.068
<v Kaddis, Laura J.>I'm surprised.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3233-0
00:21:15.068 --> 00:21:17.428
<v Kaddis, Laura J.>I'd like to express my deepest
appreciation to these sites.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3242-0
00:21:17.428 --> 00:21:20.588
<v Kaddis, Laura J.>I emailed them all out of the blue and
asked, can you please do this for me?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3271-0
00:21:20.588 --> 00:21:22.933
<v Kaddis, Laura J.>This big change again,
it's only one change,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3271-1
00:21:22.933 --> 00:21:26.998
<v Kaddis, Laura J.>but because when you do something one way
for so long, which was over e-mail,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3271-2
00:21:26.998 --> 00:21:29.708
<v Kaddis, Laura J.>to make even a small change feel like a
big change.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3273-0
00:21:29.708 --> 00:21:30.868
<v Kaddis, Laura J.>So I appreciate you guys so much.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3288-0
00:21:32.398 --> 00:21:35.038
<v Kaddis, Laura J.>And I just like to share some of the
overall feedback I received.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3299-0
00:21:35.038 --> 00:21:38.548
<v Kaddis, Laura J.>So participating sites have generally
found the board easy to use and improve</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3299-1
00:21:38.548 --> 00:21:39.358
<v Kaddis, Laura J.>it to the process.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3305-0
00:21:40.038 --> 00:21:41.598
<v Kaddis, Laura J.>So hopefully your site will too.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3309-0
00:21:44.698 --> 00:21:45.218
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3321-0
00:21:45.218 --> 00:21:48.827
<v Kaddis, Laura J.>I'd like to discuss some questions that
are raised pretty frequently during the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3321-1
00:21:48.827 --> 00:21:49.458
<v Kaddis, Laura J.>pilot program.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3336-0
00:21:50.878 --> 00:21:55.147
<v Kaddis, Laura J.>So first do I submit my review request in
Bears even if my project doesn't involve</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3336-1
00:21:55.147 --> 00:21:55.918
<v Kaddis, Laura J.>human research?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3345-0
00:21:55.998 --> 00:21:58.238
<v Kaddis, Laura J.>So yes, so say you have an animal project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3357-0
00:21:58.278 --> 00:22:01.358
<v Kaddis, Laura J.>I think I say this before you'll create a
new project in bears.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3387-0
00:22:01.398 --> 00:22:05.299
<v Kaddis, Laura J.>There are great detailed instructions how
to do this in Bears University,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3387-1
00:22:05.299 --> 00:22:09.621
<v Kaddis, Laura J.>which is linked to later in this slides
and then you will create a new package as</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3387-2
00:22:09.621 --> 00:22:13.838
<v Kaddis, Laura J.>per the written instructions and submit
your proposed agreement and intake for.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3409-0
00:22:17.098 --> 00:22:21.616
<v Kaddis, Laura J.>So my project is part of a VA program or
repository such as the collaborative</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3409-1
00:22:21.616 --> 00:22:24.338
<v Kaddis, Laura J.>studies program or a million veterans
program.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3416-0
00:22:24.538 --> 00:22:26.658
<v Kaddis, Laura J.>How do I request Ord review if needed?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3443-0
00:22:27.058 --> 00:22:30.036
<v Kaddis, Laura J.>Please if your project if your data comes
from one of these programs or</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3443-1
00:22:30.036 --> 00:22:33.469
<v Kaddis, Laura J.>repositories from any program repository,
your first step should be to contact the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3443-2
00:22:33.469 --> 00:22:34.378
<v Kaddis, Laura J.>program administrator.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3459-0
00:22:34.378 --> 00:22:38.188
<v Kaddis, Laura J.>So if you're trying to share your data
outside the VA or with another VA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3459-1
00:22:38.188 --> 00:22:40.328
<v Kaddis, Laura J.>researcher,
even you need to contact the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3459-2
00:22:40.328 --> 00:22:41.058
<v Kaddis, Laura J.>administrator.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3471-0
00:22:41.258 --> 00:22:43.273
<v Kaddis, Laura J.>See if there's anything specific you need
to do,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3471-1
00:22:43.273 --> 00:22:44.918
<v Kaddis, Laura J.>so don't submit the agreement in theirs.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3502-0
00:22:45.068 --> 00:22:48.845
<v Kaddis, Laura J.>They might already have their own process
to for DU as or Mt as they might have</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3502-1
00:22:48.845 --> 00:22:52.197
<v Kaddis, Laura J.>their own templates for DU as and Mt as.
So you need to start with the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3502-2
00:22:52.197 --> 00:22:55.548
<v Kaddis, Laura J.>administrator or whoever your point of
contact is for for the program.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3538-0
00:22:57.628 --> 00:23:01.832
<v Kaddis, Laura J.>And then on the flip side,
if you are the administrator of the VA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3538-1
00:23:01.832 --> 00:23:05.526
<v Kaddis, Laura J.>program or repository with a specific DUI
or MTA process,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3538-2
00:23:05.526 --> 00:23:09.092
<v Kaddis, Laura J.>and you are requesting Ord review help
with a DU AM TA,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3538-3
00:23:09.092 --> 00:23:10.748
<v Kaddis, Laura J.>please just contact or DC.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3542-0
00:23:10.748 --> 00:23:11.508
<v Kaddis, Laura J.>PNR via e-mail.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3558-0
00:23:11.508 --> 00:23:13.557
<v Kaddis, Laura J.>You don't have to submit the request in
theirs.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3558-1
00:23:13.557 --> 00:23:16.588
<v Kaddis, Laura J.>And please don't ask the study team to
submit their request in theirs.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3585-0
00:23:16.948 --> 00:23:21.251
<v Kaddis, Laura J.>This allows me to ensure that the program
office or or repository administrators</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3585-1
00:23:21.251 --> 00:23:23.642
<v Kaddis, Laura J.>and their procedures are not being
bypassed,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3585-2
00:23:23.642 --> 00:23:26.988
<v Kaddis, Laura J.>and then you and I can discuss exactly
what your concerns are.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3590-0
00:23:27.468 --> 00:23:29.348
<v Kaddis, Laura J.>As the administrator of the program.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3604-0
00:23:31.838 --> 00:23:33.357
<v Kaddis, Laura J.>OK.
And what if I need help with a different</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3604-1
00:23:33.357 --> 00:23:33.998
<v Kaddis, Laura J.>research agreement?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3613-0
00:23:33.998 --> 00:23:37.798
<v Kaddis, Laura J.>There are so many types of research
agreements, not just the US and Mtas.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3625-0
00:23:37.798 --> 00:23:40.718
<v Kaddis, Laura J.>What do I do with this MOU or this krata?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3634-0
00:23:40.878 --> 00:23:43.596
<v Kaddis, Laura J.>So first,
you're gonna consult your research office</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3634-1
00:23:43.596 --> 00:23:44.798
<v Kaddis, Laura J.>if it's if this is bad.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3671-0
00:23:44.798 --> 00:23:49.281
<v Kaddis, Laura J.>Example. So crate as you go to OGC star,
but if if it's something else or</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3671-1
00:23:49.281 --> 00:23:54.067
<v Kaddis, Laura J.>something not creative related after you
consult your research office which is</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3671-2
00:23:54.067 --> 00:23:58.974
<v Kaddis, Laura J.>always the first step and if they direct
you to then please contact or DCPNR via</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3671-3
00:23:58.974 --> 00:23:59.398
<v Kaddis, Laura J.>e-mail.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3708-0
00:24:04.218 --> 00:24:07.705
<v Kaddis, Laura J.>All right.
So moving on to the two newly published</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3708-1
00:24:07.705 --> 00:24:12.628
<v Kaddis, Laura J.>research Dua reference documents,
that is a Dua decision tree and a dua</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3708-2
00:24:12.628 --> 00:24:17.618
<v Kaddis, Laura J.>quick reference guide and CHEAT SHEET
summary document that I'm calling.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3746-0
00:24:19.078 --> 00:24:23.034
<v Kaddis, Laura J.>So first and foremost,
I want to emphasize there are no policy</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3746-1
00:24:23.034 --> 00:24:26.047
<v Kaddis, Laura J.>changes, OK,
both of these documents are only a</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3746-2
00:24:26.047 --> 00:24:29.814
<v Kaddis, Laura J.>summary considerate,
a compilation of existing Ord policies</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3746-3
00:24:29.814 --> 00:24:33.078
<v Kaddis, Laura J.>compiled into one place,
and two different formats.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3769-0
00:24:33.388 --> 00:24:37.344
<v Kaddis, Laura J.>So we have our visual learners can use
the decision tree and those who like to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3769-1
00:24:37.344 --> 00:24:40.348
<v Kaddis, Laura J.>read can use the guidance document,
the reference document.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3800-0
00:24:41.838 --> 00:24:46.029
<v Kaddis, Laura J.>I also want to stress before I get into
these that what is included in these</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3800-1
00:24:46.029 --> 00:24:49.458
<v Kaddis, Laura J.>documents, and as always,
what is included with any agreements</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3800-2
00:24:49.458 --> 00:24:53.158
<v Kaddis, Laura J.>guidance it may not apply to data from VA
programs or repositories.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3820-0
00:24:53.238 --> 00:24:55.755
<v Kaddis, Laura J.>Again,
they might have their own procedures.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3820-1
00:24:55.755 --> 00:24:59.558
<v Kaddis, Laura J.>They may require adua and where where Ord
policy generally doesn't.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3833-0
00:24:59.598 --> 00:25:03.492
<v Kaddis, Laura J.>So please first contact your program
administrator or repository administrator</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3833-1
00:25:03.492 --> 00:25:04.478
<v Kaddis, Laura J.>before you continue.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3857-0
00:25:07.018 --> 00:25:09.816
<v Kaddis, Laura J.>All right.
So moving on to the recently published</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3857-1
00:25:09.816 --> 00:25:13.061
<v Kaddis, Laura J.>research Dua Decision Tree,
it's published in fine print.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3857-2
00:25:13.061 --> 00:25:15.858
<v Kaddis, Laura J.>So I know it's very small,
but don't don't panic.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3860-0
00:25:15.858 --> 00:25:16.538
<v Kaddis, Laura J.>This is an overview.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3884-0
00:25:16.538 --> 00:25:19.376
<v Kaddis, Laura J.>I'll pull up a larger version shortly.
As you can see,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3884-1
00:25:19.376 --> 00:25:22.937
<v Kaddis, Laura J.>the tree is divided into four different
lanes on the left side here,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3884-2
00:25:22.937 --> 00:25:26.858
<v Kaddis, Laura J.>and you will start at the beginning in
the top left and work your way down.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3890-0
00:25:27.258 --> 00:25:29.384
<v Kaddis, Laura J.>So again,
I will go through in a little more detail</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3890-1
00:25:29.384 --> 00:25:30.078
<v Kaddis, Laura J.>in just a moment.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3923-0
00:25:32.798 --> 00:25:38.556
<v Kaddis, Laura J.>So this is the decision tree helps you
decide when adua is permitted and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3923-1
00:25:38.556 --> 00:25:43.998
<v Kaddis, Laura J.>required to send human data to a non VA
collaborator per Ord policy.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3933-0
00:25:43.998 --> 00:25:49.078
<v Kaddis, Laura J.>So again, the trees available in find Pro,
so I'm going to switch to that now.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3940-0
00:25:58.948 --> 00:26:01.002
<v Kaddis, Laura J.>OK.
Can I have a thumbs up if that's zoomed</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3940-1
00:26:01.002 --> 00:26:01.468
<v Kaddis, Laura J.>in enough?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3946-0
00:26:05.728 --> 00:26:06.808
<v Kaddis, Laura J.>OK, cool. Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3949-0
00:26:07.008 --> 00:26:07.448
<v Kaddis, Laura J.>It's kind of.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3952-0
00:26:07.448 --> 00:26:08.008
<v Kaddis, Laura J.>It's kinda hard, I know.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3975-0
00:26:08.008 --> 00:26:11.032
<v Kaddis, Laura J.>I know the document doesn't really lend
itself well to being presented,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3975-1
00:26:11.032 --> 00:26:13.216
<v Kaddis, Laura J.>but once you're on your screen and you
download it,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/3975-2
00:26:13.216 --> 00:26:14.728
<v Kaddis, Laura J.>you can zoom in as much as you need.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4008-0
00:26:16.238 --> 00:26:19.882
<v Kaddis, Laura J.>So as I said,
it's divided into four different work</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4008-1
00:26:19.882 --> 00:26:23.105
<v Kaddis, Laura J.>column swim lanes,
four different lanes here,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4008-2
00:26:23.105 --> 00:26:26.678
<v Kaddis, Laura J.>general requirements, human subjects,
protections.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4009-0
00:26:26.838 --> 00:26:27.678
<v Kaddis, Laura J.>Scrolling down.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4019-0
00:26:29.358 --> 00:26:31.838
<v Kaddis, Laura J.>Information security and finally, privacy.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4034-0
00:26:32.348 --> 00:26:36.643
<v Kaddis, Laura J.>I'm gonna scroll back up to the top sworn
in case anyone wants to look away.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4034-1
00:26:36.643 --> 00:26:38.428
<v Kaddis, Laura J.>'cause motion sickness is awful.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4075-0
00:26:39.998 --> 00:26:45.452
<v Kaddis, Laura J.>So obviously you're gonna start at the
beginning of this big start and the blue</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4075-1
00:26:45.452 --> 00:26:48.724
<v Kaddis, Laura J.>arrow here.
So you'll see the the Navy blue ish</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4075-2
00:26:48.724 --> 00:26:54.041
<v Kaddis, Laura J.>rectangles have questions in them that
are yes or no answers and depending on</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4075-3
00:26:54.041 --> 00:26:56.358
<v Kaddis, Laura J.>your answer is how you'll proceed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4084-0
00:26:56.558 --> 00:26:59.038
<v Kaddis, Laura J.>So kinda like a choose your own adventure,
but not quite as fun.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4087-0
00:26:59.038 --> 00:27:00.358
<v Kaddis, Laura J.>But still pretty important.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4095-0
00:27:01.098 --> 00:27:02.898
<v Kaddis, Laura J.>So I'm just going to go through it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4110-0
00:27:03.378 --> 00:27:07.095
<v Kaddis, Laura J.>I hadn't planned to go through box by box,
but I really think it's important so that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4110-1
00:27:07.095 --> 00:27:08.538
<v Kaddis, Laura J.>you're looking at it on your own.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4111-0
00:27:08.538 --> 00:27:09.658
<v Kaddis, Laura J.>You know what?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4127-0
00:27:09.658 --> 00:27:14.258
<v Kaddis, Laura J.>The boxes mean and where to go from there.
So, and I think I'm. I'm great on time.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4129-0
00:27:14.258 --> 00:27:15.738
<v Kaddis, Laura J.>So we're good, all right.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4156-0
00:27:15.778 --> 00:27:20.416
<v Kaddis, Laura J.>So our first box here states are the
terms of the data transfer and use</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4156-1
00:27:20.416 --> 00:27:24.538
<v Kaddis, Laura J.>included in any other agreement such as a
Creta or subcontract.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4161-0
00:27:24.978 --> 00:27:27.904
<v Kaddis, Laura J.>If yes,
you'll follow this green arrow up to this</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4161-1
00:27:27.904 --> 00:27:28.138
<v Kaddis, Laura J.>box.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4166-0
00:27:28.878 --> 00:27:30.518
<v Kaddis, Laura J.>That states is BA a party to the
agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4207-0
00:27:31.108 --> 00:27:34.959
<v Kaddis, Laura J.>Agreement. If yes,
please continue to this purple circle and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4207-1
00:27:34.959 --> 00:27:39.882
<v Kaddis, Laura J.>you will check the agreement for the
terms. A separate DUA would not be used.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4207-2
00:27:39.882 --> 00:27:44.742
<v Kaddis, Laura J.>Now you see here and throughout this this
document there are some footnotes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4207-3
00:27:44.742 --> 00:27:48.718
<v Kaddis, Laura J.>So please if you arrive at a footnote,
especially at that one.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4226-0
00:27:48.718 --> 00:27:53.623
<v Kaddis, Laura J.>Of the green shapes or the circle here,
go Scroll down to the bottom where the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4226-1
00:27:53.623 --> 00:27:54.988
<v Kaddis, Laura J.>list of footnotes are.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4233-0
00:27:54.988 --> 00:27:55.988
<v Kaddis, Laura J.>There will be more details.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4245-0
00:27:56.028 --> 00:27:59.298
<v Kaddis, Laura J.>Sometimes those details are well,
maybe you might still need a DUI,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4245-1
00:27:59.298 --> 00:28:00.788
<v Kaddis, Laura J.>so please Scroll down to those.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4255-0
00:28:01.068 --> 00:28:05.508
<v Kaddis, Laura J.>And make sure you're following the right
order. So if I step back.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4270-0
00:28:05.508 --> 00:28:10.068
<v Kaddis, Laura J.>So VA is VA parts of the agreement,
if not, you arrive at the screen.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4277-0
00:28:10.068 --> 00:28:12.781
<v Kaddis, Laura J.>Yes,
I did have to look up what A7 sided</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4277-1
00:28:12.781 --> 00:28:13.508
<v Kaddis, Laura J.>figure was.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4283-0
00:28:13.508 --> 00:28:14.588
<v Kaddis, Laura J.>It's green septicon.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4284-0
00:28:15.348 --> 00:28:17.268
<v Kaddis, Laura J.>Which states consult OR?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4293-0
00:28:17.268 --> 00:28:19.068
<v Kaddis, Laura J.>DCPNR proceed if instructed by Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4306-0
00:28:19.748 --> 00:28:22.320
<v Kaddis, Laura J.>So if you arrive at any of these green
septicons,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4306-1
00:28:22.320 --> 00:28:24.068
<v Kaddis, Laura J.>it means you have hit a roadblock.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4346-0
00:28:24.738 --> 00:28:29.308
<v Kaddis, Laura J.>Don't panic. Just contact the program,
office or the individual named in that in</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4346-1
00:28:29.308 --> 00:28:32.354
<v Kaddis, Laura J.>that shape,
and just explain what you're trying to do</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4346-2
00:28:32.354 --> 00:28:36.810
<v Kaddis, Laura J.>and why and how you've applied to them
and tell them that this tree is telling</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4346-3
00:28:36.810 --> 00:28:37.938
<v Kaddis, Laura J.>you to contact them.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4349-0
00:28:37.938 --> 00:28:39.218
<v Kaddis, Laura J.>So that is what you're doing.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4351-0
00:28:39.458 --> 00:28:40.378
<v Kaddis, Laura J.>Explain your problem.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4385-0
00:28:41.868 --> 00:28:45.395
<v Kaddis, Laura J.>Hopefully they can assist you with
getting everything squared away and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4385-1
00:28:45.395 --> 00:28:49.070
<v Kaddis, Laura J.>clearing that roadblock if when you're
able to do that and they tell you,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4385-2
00:28:49.070 --> 00:28:51.404
<v Kaddis, Laura J.>you can proceed,
please come back to the tree.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4385-3
00:28:51.404 --> 00:28:55.228
<v Kaddis, Laura J.>If they if they say something like yeah,
you can totally use the DOA in the.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4387-0
00:28:55.228 --> 00:28:55.238
<v Kaddis, Laura J.>Situation.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4397-0
00:28:56.258 --> 00:28:59.458
<v Kaddis, Laura J.>Don't assume that means that all your
requirements have been met.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4409-0
00:28:59.498 --> 00:29:03.218
<v Kaddis, Laura J.>It might just be that you've met all the
requirements for that specific roadblock.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4418-0
00:29:03.258 --> 00:29:05.738
<v Kaddis, Laura J.>So if they say that,
please continue on with the tree.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4425-0
00:29:06.458 --> 00:29:09.938
<v Kaddis, Laura J.>So let's say we do have an agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4434-0
00:29:10.298 --> 00:29:11.938
<v Kaddis, Laura J.>Virginia is not a part of the agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4457-0
00:29:11.938 --> 00:29:15.964
<v Kaddis, Laura J.>We consulted Ordc PNR,
who told you to continue on,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4457-1
00:29:15.964 --> 00:29:20.298
<v Kaddis, Laura J.>so our next box here is intellectual
property involved.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4468-0
00:29:20.458 --> 00:29:22.829
<v Kaddis, Laura J.>If so,
you need to contact your technology</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4468-1
00:29:22.829 --> 00:29:24.978
<v Kaddis, Laura J.>transfer specialist before you proceed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4505-0
00:29:25.428 --> 00:29:30.053
<v Kaddis, Laura J.>Generally adua is not used to transfer
anything with intellectual property,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4505-1
00:29:30.053 --> 00:29:35.043
<v Kaddis, Laura J.>so you need to first contact your TTS if
they if the answer is no or if they tell</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4505-2
00:29:35.043 --> 00:29:38.330
<v Kaddis, Laura J.>you to proceed,
our next boxes has the data custodian</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4505-3
00:29:38.330 --> 00:29:39.668
<v Kaddis, Laura J.>approved the transfer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4506-0
00:29:39.708 --> 00:29:40.228
<v Kaddis, Laura J.>So I will.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4509-0
00:29:40.228 --> 00:29:40.988
<v Kaddis, Laura J.>I will explain later.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4540-0
00:29:40.988 --> 00:29:43.665
<v Kaddis, Laura J.>More details,
what data custodian is but the long and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4540-1
00:29:43.665 --> 00:29:47.531
<v Kaddis, Laura J.>short of it is that the data custodian
needs to approve the transfer. If not,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4540-2
00:29:47.531 --> 00:29:50.108
<v Kaddis, Laura J.>you can't transfer the the data because
it's there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4543-0
00:29:50.108 --> 00:29:50.708
<v Kaddis, Laura J.>It's their data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4545-0
00:29:50.708 --> 00:29:51.668
<v Kaddis, Laura J.>They're responsible for it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4549-0
00:29:51.668 --> 00:29:53.228
<v Kaddis, Laura J.>If they say no, then you can't do it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4555-0
00:29:53.898 --> 00:29:56.378
<v Kaddis, Laura J.>But if and when they give you permission
to do so.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4567-0
00:29:57.658 --> 00:30:01.298
<v Kaddis, Laura J.>You'll continue down into the human
subjects protections lane.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4575-0
00:30:01.698 --> 00:30:03.858
<v Kaddis, Laura J.>So this lane only has two questions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4623-0
00:30:04.658 --> 00:30:09.591
<v Kaddis, Laura J.>Is the data transfer described in a VA
approved protocol or protocol amendment?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4623-1
00:30:09.591 --> 00:30:14.586
<v Kaddis, Laura J.>And if data is from a consented cohort,
is the data transfer consistent with the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4623-2
00:30:14.586 --> 00:30:17.607
<v Kaddis, Laura J.>informed consent or has the consent been
waived?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4623-3
00:30:17.607 --> 00:30:22.108
<v Kaddis, Laura J.>If your answer is no to either of these
questions, you will arrive here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4630-0
00:30:22.108 --> 00:30:24.415
<v Kaddis, Laura J.>In the center,
we need to consult your facility research</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4630-1
00:30:24.415 --> 00:30:24.698
<v Kaddis, Laura J.>office.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4643-0
00:30:25.438 --> 00:30:28.417
<v Kaddis, Laura J.>Per your procedures,
you actually might need to consult your</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4643-1
00:30:28.417 --> 00:30:29.198
<v Kaddis, Laura J.>RDC or your IRB.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4676-0
00:30:29.198 --> 00:30:34.135
<v Kaddis, Laura J.>Please follow your procedures,
but so contact whoever your authority is</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4676-1
00:30:34.135 --> 00:30:38.181
<v Kaddis, Laura J.>on your human protection and your
protocols. Again, if if,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4676-2
00:30:38.181 --> 00:30:42.570
<v Kaddis, Laura J.>when these issues are resolved,
you'll continue on in the tree,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4676-3
00:30:42.570 --> 00:30:44.078
<v Kaddis, Laura J.>I'm gonna Scroll down.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4684-0
00:30:45.948 --> 00:30:49.988
<v Kaddis, Laura J.>To our information security lane,
the three questions for this lane.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4692-0
00:30:51.668 --> 00:30:54.148
<v Kaddis, Laura J.>Will only a copy of Virginia data be
transferred?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4715-0
00:30:55.448 --> 00:31:00.374
<v Kaddis, Laura J.>Will ownership of the copy of Virginia
data transferred to the recipient and has</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4715-1
00:31:00.374 --> 00:31:03.962
<v Kaddis, Laura J.>the facility ISSU,
reviewed and approved the data transfer</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4715-2
00:31:03.962 --> 00:31:04.448
<v Kaddis, Laura J.>request?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4742-0
00:31:05.828 --> 00:31:09.791
<v Kaddis, Laura J.>If your answer is no to any of these
questions and you need to take a step</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4742-1
00:31:09.791 --> 00:31:13.913
<v Kaddis, Laura J.>back and consult your facility issso,
typically a DUI is not used to transfer</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4742-2
00:31:13.913 --> 00:31:14.388
<v Kaddis, Laura J.>transfer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4756-0
00:31:16.148 --> 00:31:18.762
<v Kaddis, Laura J.>Sorry,
especially a research view is not used to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4756-1
00:31:18.762 --> 00:31:20.148
<v Kaddis, Laura J.>transfer original VA data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4769-0
00:31:20.148 --> 00:31:25.028
<v Kaddis, Laura J.>And it's not used to transfer data for
which the VA will return retain ownership.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4783-0
00:31:25.898 --> 00:31:30.378
<v Kaddis, Laura J.>And it is per policy or facility ISSO has
to approve the data transfer request.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4805-0
00:31:31.868 --> 00:31:34.714
<v Kaddis, Laura J.>So again,
if you have knowed any of these questions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4805-1
00:31:34.714 --> 00:31:37.988
<v Kaddis, Laura J.>please contact your facility issso.
See what you need to do.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4817-0
00:31:37.988 --> 00:31:40.712
<v Kaddis, Laura J.>Maybe there's a different,
a different DUA you need to use,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4817-1
00:31:40.712 --> 00:31:42.028
<v Kaddis, Laura J.>or you're trying to transfer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4841-0
00:31:43.828 --> 00:31:48.222
<v Kaddis, Laura J.>Original data for storage purposes,
so please they might have other</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4841-1
00:31:48.222 --> 00:31:51.711
<v Kaddis, Laura J.>requirements,
so please talk to them if they tell you</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4841-2
00:31:51.711 --> 00:31:55.201
<v Kaddis, Laura J.>to proceed.
We will move on down to our largest oops,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4841-3
00:31:55.201 --> 00:31:55.588
<v Kaddis, Laura J.>sorry.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4868-0
00:31:55.858 --> 00:31:59.821
<v Kaddis, Laura J.>Our largest language is our privacy lane,
which starts with the most important</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4868-1
00:31:59.821 --> 00:32:03.835
<v Kaddis, Laura J.>question for privacy has the facility
Privacy Officer reviewed and approved the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4868-2
00:32:03.835 --> 00:32:04.938
<v Kaddis, Laura J.>data transfer request?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4879-0
00:32:04.938 --> 00:32:08.338
<v Kaddis, Laura J.>I know I'm pretty sure I've already said
this twice in this presentation,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4879-1
00:32:08.338 --> 00:32:09.578
<v Kaddis, Laura J.>but this is very important.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4905-0
00:32:09.578 --> 00:32:12.077
<v Kaddis, Laura J.>Again,
we have to confirm that the Privacy</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4905-1
00:32:12.077 --> 00:32:16.378
<v Kaddis, Laura J.>authority to share the data exists and
confirm the type of data involved.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4914-0
00:32:16.378 --> 00:32:21.138
<v Kaddis, Laura J.>That'll save everyone headaches later on,
so if not, please go talk to your PO.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4926-0
00:32:22.148 --> 00:32:25.268
<v Kaddis, Laura J.>If they tell you you can proceed,
you will continue back up here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4935-0
00:32:26.378 --> 00:32:29.618
<v Kaddis, Laura J.>And then the type of data determines how
we continue.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4957-0
00:32:31.148 --> 00:32:35.596
<v Kaddis, Laura J.>So if your data contains protected health
information or Phi and or personally</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4957-1
00:32:35.596 --> 00:32:37.228
<v Kaddis, Laura J.>identifiable information PII.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4986-0
00:32:39.858 --> 00:32:43.008
<v Kaddis, Laura J.>Actually,
if your data does not contain Phi or PII.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4986-1
00:32:43.008 --> 00:32:47.550
<v Kaddis, Laura J.>So if it contains DE identified data as
confirmed by your Privacy Officer,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/4986-2
00:32:47.550 --> 00:32:48.458
<v Kaddis, Laura J.>please proceed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5005-0
00:32:48.458 --> 00:32:51.704
<v Kaddis, Laura J.>Follow this arrow down here to this blue
Oval.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5005-1
00:32:51.704 --> 00:32:54.258
<v Kaddis, Laura J.>Does the data custodian require adua?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5014-0
00:32:54.898 --> 00:32:57.618
<v Kaddis, Laura J.>If no, then adua is not required.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5026-0
00:32:57.778 --> 00:33:02.018
<v Kaddis, Laura J.>If yes then please follow this arrow all
the way over to our green circle.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5040-0
00:33:02.018 --> 00:33:04.664
<v Kaddis, Laura J.>So Adua is required,
but if you made it this far,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5040-1
00:33:04.664 --> 00:33:07.098
<v Kaddis, Laura J.>there's nothing that is prohibiting that
DUA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5043-0
00:33:07.178 --> 00:33:07.818
<v Kaddis, Laura J.>So you did good.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5046-0
00:33:07.818 --> 00:33:08.698
<v Kaddis, Laura J.>Just need to do the DUI.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5051-0
00:33:09.478 --> 00:33:10.878
<v Kaddis, Laura J.>I'm gonna back up now.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5096-0
00:33:12.058 --> 00:33:16.679
<v Kaddis, Laura J.>If your data does include Phi and or PII,
please proceed this way.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5096-1
00:33:16.679 --> 00:33:21.782
<v Kaddis, Laura J.>Then the next question is the data
transfer and use described in a signed</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5096-2
00:33:21.782 --> 00:33:26.816
<v Kaddis, Laura J.>informed consent document and HIPAA
authorization or a VA approved HIPAA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5096-3
00:33:26.816 --> 00:33:27.298
<v Kaddis, Laura J.>waiver.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5114-0
00:33:27.618 --> 00:33:30.946
<v Kaddis, Laura J.>If not,
this purple rectangle states is the data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5114-1
00:33:30.946 --> 00:33:33.458
<v Kaddis, Laura J.>to be transferred a limited data set?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5135-0
00:33:33.858 --> 00:33:36.135
<v Kaddis, Laura J.>If yes,
then a DUI is required as a covered</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5135-1
00:33:36.135 --> 00:33:38.515
<v Kaddis, Laura J.>entity.
We are subject to HIPA which requires</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5135-2
00:33:38.515 --> 00:33:40.378
<v Kaddis, Laura J.>adua to transfer a limited data set.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5147-0
00:33:41.158 --> 00:33:45.158
<v Kaddis, Laura J.>If it is not a limited data set,
then a DUI is not permitted.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5157-0
00:33:45.318 --> 00:33:47.438
<v Kaddis, Laura J.>This if you got this far,
this means you haven't.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5172-0
00:33:48.318 --> 00:33:50.759
<v Kaddis, Laura J.>You're not satisfied all the privacy
requirements,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5172-1
00:33:50.759 --> 00:33:53.678
<v Kaddis, Laura J.>the privacy authority to make the
disclosure does not exist.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5189-0
00:33:53.678 --> 00:33:57.139
<v Kaddis, Laura J.>So you need to go back to the privacy
officer again if you started with the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5189-1
00:33:57.139 --> 00:33:59.278
<v Kaddis, Laura J.>Privacy Officer,
unlikely you'll get this far.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5194-0
00:33:59.278 --> 00:34:01.038
<v Kaddis, Laura J.>But if you do,
please go back and talk to them.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5215-0
00:34:02.588 --> 00:34:06.201
<v Kaddis, Laura J.>So backing up once again,
let's say the data transfer and use are</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5215-1
00:34:06.201 --> 00:34:09.868
<v Kaddis, Laura J.>described in an informed consent document
and HIPAA authorization.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5221-0
00:34:09.868 --> 00:34:11.748
<v Kaddis, Laura J.>So we come over here to this blue circle.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5241-0
00:34:12.878 --> 00:34:19.198
<v Kaddis, Laura J.>Follow this arrow all the way back over
to R does the data custodian require adua?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5250-0
00:34:19.758 --> 00:34:22.638
<v Kaddis, Laura J.>And again, if not, adua is not required.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5254-0
00:34:22.678 --> 00:34:24.878
<v Kaddis, Laura J.>If so, Adua is required.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5297-0
00:34:25.158 --> 00:34:27.796
<v Kaddis, Laura J.>So again,
the data custodian has the authority to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5297-1
00:34:27.796 --> 00:34:30.803
<v Kaddis, Laura J.>require adua even when otherwise not
required by policy,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5297-2
00:34:30.803 --> 00:34:35.077
<v Kaddis, Laura J.>and this could be for anything even to
transfer DE identified data within the VA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5297-3
00:34:35.077 --> 00:34:39.350
<v Kaddis, Laura J.>to another VHA facility for VA research.
If they say adua is needed and you need</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5297-4
00:34:39.350 --> 00:34:39.508
<v Kaddis, Laura J.>to.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5300-0
00:34:39.638 --> 00:34:39.958
<v Kaddis, Laura J.>Do adua.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5302-0
00:34:41.498 --> 00:34:42.698
<v Kaddis, Laura J.>Going backwards.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5320-0
00:34:44.188 --> 00:34:48.751
<v Kaddis, Laura J.>So if the data transfer and uses
described in a VA approved HIPA waiver,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5320-1
00:34:48.751 --> 00:34:50.188
<v Kaddis, Laura J.>then a DUI is required.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5323-0
00:34:51.908 --> 00:34:52.348
<v Kaddis, Laura J.>All right.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5334-0
00:34:52.348 --> 00:34:55.468
<v Kaddis, Laura J.>So that is that. Again,
you'll see these footnotes throughout.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5336-0
00:34:55.468 --> 00:34:55.988
<v Kaddis, Laura J.>I'm going to Scroll down.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5360-0
00:34:57.628 --> 00:35:00.192
<v Kaddis, Laura J.>So if you continue down here,
you'll see there's more information</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5360-1
00:35:00.192 --> 00:35:03.028
<v Kaddis, Laura J.>that'll just help you as you work your
way through the through the tree.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5367-0
00:35:03.028 --> 00:35:04.195
<v Kaddis, Laura J.>I'm not going to read through all of
these,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5367-1
00:35:04.195 --> 00:35:05.308
<v Kaddis, Laura J.>but you can read through them on your own.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5372-0
00:35:06.908 --> 00:35:08.788
<v Kaddis, Laura J.>All right,
so I'm going to return to my PowerPoint.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5377-0
00:35:10.428 --> 00:35:11.708
<v Kaddis, Laura J.>I'm going to pause for some water.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5380-0
00:35:16.018 --> 00:35:16.498
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5382-0
00:35:16.538 --> 00:35:17.698
<v Kaddis, Laura J.>Bring that back up.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5388-0
00:35:24.858 --> 00:35:26.818
<v Kaddis, Laura J.>All right, so continuing on.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5394-0
00:35:28.768 --> 00:35:30.368
<v Kaddis, Laura J.>Maybe there we go.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5402-0
00:35:30.368 --> 00:35:33.288
<v Kaddis, Laura J.>All right.
So Cua Chi quick reference guide.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5407-0
00:35:33.288 --> 00:35:34.248
<v Kaddis, Laura J.>It's not a sheet.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5416-0
00:35:34.248 --> 00:35:37.596
<v Kaddis, Laura J.>It's 6 pages long,
but it's where it's not super heavy on</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5416-1
00:35:37.596 --> 00:35:38.288
<v Kaddis, Laura J.>information.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5428-0
00:35:39.008 --> 00:35:42.248
<v Kaddis, Laura J.>It is all the same information as the as
the decision tree.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5446-0
00:35:42.248 --> 00:35:46.514
<v Kaddis, Laura J.>It's just in a written format,
so if you intake information better that</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5446-1
00:35:46.514 --> 00:35:48.528
<v Kaddis, Laura J.>way, please by all means use that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5447-0
00:35:48.528 --> 00:35:49.328
<v Kaddis, Laura J.>That's fine.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5453-0
00:35:49.568 --> 00:35:50.848
<v Kaddis, Laura J.>Again, it's. It's a summary.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5457-0
00:35:50.848 --> 00:35:51.768
<v Kaddis, Laura J.>It's not new policy.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5470-0
00:35:51.768 --> 00:35:56.648
<v Kaddis, Laura J.>It's a summary of VHA Handbook 1200.
12 requirements and OIT requirements.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5478-0
00:35:56.648 --> 00:35:58.778
<v Kaddis, Laura J.>Those are are what we need to go contact
ISIS.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5480-0
00:35:58.778 --> 00:36:00.058
<v Kaddis, Laura J.>So if we have any issues with.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5490-0
00:36:01.628 --> 00:36:02.948
<v Kaddis, Laura J.>The only there is one little difference.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5506-0
00:36:02.948 --> 00:36:06.573
<v Kaddis, Laura J.>The very last section,
just as a as an add in covers data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5506-1
00:36:06.573 --> 00:36:07.948
<v Kaddis, Laura J.>sharing within the VA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5530-0
00:36:08.508 --> 00:36:11.407
<v Kaddis, Laura J.>So in summary,
the UA is typically only required to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5530-1
00:36:11.407 --> 00:36:15.030
<v Kaddis, Laura J.>share data within the VA if it's required
by the data custodian,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5530-2
00:36:15.030 --> 00:36:17.148
<v Kaddis, Laura J.>and that is also available in vinepro.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5549-0
00:36:17.588 --> 00:36:20.712
<v Kaddis, Laura J.>So I'm not gonna pull that up just
because it's literally the same</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5549-1
00:36:20.712 --> 00:36:24.629
<v Kaddis, Laura J.>information and it's just a Word document,
but you can access that infine Pro right</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5549-2
00:36:24.629 --> 00:36:24.908
<v Kaddis, Laura J.>there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5566-0
00:36:28.318 --> 00:36:30.428
<v Kaddis, Laura J.>OK,
some questions I've received about the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5566-1
00:36:30.428 --> 00:36:33.078
<v Kaddis, Laura J.>tree and the reference document.
I'd like to go over.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5584-0
00:36:35.458 --> 00:36:40.098
<v Kaddis, Laura J.>So who has the authority to require DUI?
If it's not required by Ord policy?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5597-0
00:36:40.458 --> 00:36:44.818
<v Kaddis, Laura J.>So this could be the data custodian which
I will touch on in the next slide.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5613-0
00:36:44.938 --> 00:36:48.335
<v Kaddis, Laura J.>There might be some other VA or VHA
policy, such as OIT,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5613-1
00:36:48.335 --> 00:36:50.658
<v Kaddis, Laura J.>depending on the type of data involved.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5628-0
00:36:50.698 --> 00:36:53.518
<v Kaddis, Laura J.>Again,
I will speak on later and your facility</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5628-1
00:36:53.518 --> 00:36:56.158
<v Kaddis, Laura J.>policy,
so you need to follow your facility</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5628-2
00:36:56.158 --> 00:36:56.698
<v Kaddis, Laura J.>policies.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5635-0
00:36:56.698 --> 00:37:00.698
<v Kaddis, Laura J.>They they can't be less stringent than
the than the national policy.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5648-0
00:37:00.698 --> 00:37:04.232
<v Kaddis, Laura J.>But if they say you need a DUI for
something, that policy wise,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5648-1
00:37:04.232 --> 00:37:07.378
<v Kaddis, Laura J.>maybe you don't,
then you need to follow their policies.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5658-0
00:37:09.618 --> 00:37:11.978
<v Kaddis, Laura J.>So who is this mysterious data custodian?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5687-0
00:37:12.538 --> 00:37:17.123
<v Kaddis, Laura J.>So this is the entity or program office
facility which quote UN quote owns the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5687-1
00:37:17.123 --> 00:37:19.793
<v Kaddis, Laura J.>data,
the quote because we all know the Under</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5687-2
00:37:19.793 --> 00:37:22.578
<v Kaddis, Laura J.>Secretary of Health actually owns the VHA
data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5698-0
00:37:22.618 --> 00:37:26.498
<v Kaddis, Laura J.>So think of the custodian as the keeper
of the data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5710-0
00:37:27.018 --> 00:37:29.738
<v Kaddis, Laura J.>So this might be the VA facility
releasing the data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5716-0
00:37:29.738 --> 00:37:33.298
<v Kaddis, Laura J.>Maybe a program or repository
administrator so.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5719-0
00:37:34.428 --> 00:37:34.988
<v Kaddis, Laura J.>While while.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5729-0
00:37:34.988 --> 00:37:37.628
<v Kaddis, Laura J.>So say APVAPI require data from a VA
repository.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5734-0
00:37:37.628 --> 00:37:39.788
<v Kaddis, Laura J.>So I'll pull up situation that's happened.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5772-0
00:37:40.258 --> 00:37:43.634
<v Kaddis, Laura J.>Pretty frequently,
while the while the Pi is responsible for</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5772-1
00:37:43.634 --> 00:37:48.061
<v Kaddis, Laura J.>the data while it's in their possession,
per terms of the repository SOP or any</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5772-2
00:37:48.061 --> 00:37:52.709
<v Kaddis, Laura J.>agreements they have with the repository,
the Pi does not become the data custodian</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5772-3
00:37:52.709 --> 00:37:54.978
<v Kaddis, Laura J.>so that that remains with the repository.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5779-0
00:37:54.978 --> 00:37:56.378
<v Kaddis, Laura J.>So if the VA wants to.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5796-0
00:37:56.418 --> 00:37:58.834
<v Kaddis, Laura J.>Or sorry,
the V API wants to further share the data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5796-1
00:37:58.834 --> 00:38:02.458
<v Kaddis, Laura J.>or use it for a different purpose than
what they originally requested it for.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5807-0
00:38:02.458 --> 00:38:05.357
<v Kaddis, Laura J.>Then you need to go back to the
repository because they are still the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5807-1
00:38:05.357 --> 00:38:05.978
<v Kaddis, Laura J.>data custodian.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5814-0
00:38:09.968 --> 00:38:11.888
<v Kaddis, Laura J.>This is also coming up a lot recently.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5828-0
00:38:11.888 --> 00:38:16.716
<v Kaddis, Laura J.>So how do I store original VA data as the
original federal record on an affiliate</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5828-1
00:38:16.716 --> 00:38:17.128
<v Kaddis, Laura J.>system?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5847-0
00:38:17.128 --> 00:38:20.943
<v Kaddis, Laura J.>And I think I've been seeing this most
often recently because sometimes our</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5847-1
00:38:20.943 --> 00:38:24.808
<v Kaddis, Laura J.>state universities get more funding than
we get from the federal government.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5857-0
00:38:24.808 --> 00:38:28.448
<v Kaddis, Laura J.>So they have better systems, more storage,
anything like that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5863-0
00:38:28.638 --> 00:38:30.118
<v Kaddis, Laura J.>For this you need to consult your ISS.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5870-0
00:38:30.118 --> 00:38:33.758
<v Kaddis, Laura J.>So it it might not even be a research
purpose.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5884-0
00:38:33.758 --> 00:38:36.518
<v Kaddis, Laura J.>So you really need to consult them and
see what agreements are needed.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5889-0
00:38:36.518 --> 00:38:37.758
<v Kaddis, Laura J.>Maybe a non research DUA?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5894-0
00:38:38.598 --> 00:38:40.518
<v Kaddis, Laura J.>It could be a specific MOU.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5912-0
00:38:40.518 --> 00:38:43.764
<v Kaddis, Laura J.>You might also need an authority to
operate depending on what you're doing,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5912-1
00:38:43.764 --> 00:38:45.558
<v Kaddis, Laura J.>where the data's going, what kind of data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5923-0
00:38:45.758 --> 00:38:49.078
<v Kaddis, Laura J.>So please go consult your ISS oi know
I've said that 20 times.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5929-0
00:38:49.078 --> 00:38:51.878
<v Kaddis, Laura J.>I'm so glad our super valuable Isos are
back.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5932-0
00:38:51.878 --> 00:38:52.678
<v Kaddis, Laura J.>Welcome back.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5933-0
00:38:52.718 --> 00:38:53.398
<v Kaddis, Laura J.>Love you guys.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5934-0
00:38:53.438 --> 00:38:54.038
<v Kaddis, Laura J.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5937-0
00:38:56.098 --> 00:38:56.498
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5945-0
00:38:56.498 --> 00:38:58.640
<v Kaddis, Laura J.>Finally,
it's a DUI required to transfer animals</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5945-1
00:38:58.640 --> 00:38:58.858
<v Kaddis, Laura J.>data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5959-0
00:38:58.858 --> 00:39:03.378
<v Kaddis, Laura J.>So there is no Ord policy that requires a
DUI to transfer animal data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/5971-0
00:39:03.418 --> 00:39:08.018
<v Kaddis, Laura J.>However, if the data is sensitive,
it may be required by OIT policy.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6007-0
00:39:08.018 --> 00:39:10.582
<v Kaddis, Laura J.>So again,
please consult your mighty issso</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6007-1
00:39:10.582 --> 00:39:14.995
<v Kaddis, Laura J.>insensitive animal data. Specifically,
is photographic or video images of</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6007-2
00:39:14.995 --> 00:39:19.050
<v Kaddis, Laura J.>category D or E procedures,
so I won't click on these links but you</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6007-3
00:39:19.050 --> 00:39:20.898
<v Kaddis, Laura J.>so you can click on them later.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6015-0
00:39:21.608 --> 00:39:24.088
<v Kaddis, Laura J.>This will take you to an OIT knowledge
based article.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6037-0
00:39:24.558 --> 00:39:29.616
<v Kaddis, Laura J.>On their definition of sensitive and this
will take you to the USDA pain and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6037-1
00:39:29.616 --> 00:39:30.798
<v Kaddis, Laura J.>distress category.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6048-0
00:39:30.798 --> 00:39:34.878
<v Kaddis, Laura J.>So it'll state exactly what is included
in those category D&amp;E procedures.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6052-0
00:39:34.958 --> 00:39:36.038
<v Kaddis, Laura J.>And again, this is only on stress.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6063-0
00:39:36.038 --> 00:39:39.158
<v Kaddis, Laura J.>It's only photographic or video images.
It doesn't apply to just data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6065-0
00:39:40.648 --> 00:39:42.248
<v Kaddis, Laura J.>Like written data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6087-0
00:39:42.828 --> 00:39:45.669
<v Kaddis, Laura J.>All right.
And is adua required to receive data from</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6087-1
00:39:45.669 --> 00:39:48.348
<v Kaddis, Laura J.>a non VA entity?
This is an interesting question.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6092-0
00:39:48.348 --> 00:39:50.788
<v Kaddis, Laura J.>I do get often actually was talked.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6126-0
00:39:50.788 --> 00:39:55.416
<v Kaddis, Laura J.>I asked the our Ords Privacy Officer
yesterday because it seemed like a trick</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6126-1
00:39:55.416 --> 00:39:58.560
<v Kaddis, Laura J.>question,
but really it depends on the type of data,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6126-2
00:39:58.560 --> 00:40:01.348
<v Kaddis, Laura J.>the type of entity and that entity's
policies.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6144-0
00:40:01.348 --> 00:40:03.988
<v Kaddis, Laura J.>So say the other entities a covered
entity,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6144-1
00:40:03.988 --> 00:40:07.828
<v Kaddis, Laura J.>so they're subject to HIPAA and the data
consents of a limited.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6154-0
00:40:07.828 --> 00:40:11.308
<v Kaddis, Laura J.>Data consists of a limited data set.
Then a DUI is required under HIPAA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6157-0
00:40:12.048 --> 00:40:13.008
<v Kaddis, Laura J.>Hopefully theoretically.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6180-0
00:40:13.358 --> 00:40:16.478
<v Kaddis, Laura J.>Ideally,
they're aware of that and they enforce</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6180-1
00:40:16.478 --> 00:40:19.468
<v Kaddis, Laura J.>that,
but really it is up to the other entity</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6180-2
00:40:19.468 --> 00:40:20.638
<v Kaddis, Laura J.>in their policies.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6187-0
00:40:20.918 --> 00:40:24.478
<v Kaddis, Laura J.>Ord policy does not set DUI requirements
when receiving data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6220-0
00:40:27.438 --> 00:40:32.101
<v Kaddis, Laura J.>Some other resources for these this.
These changes will just really the Bears</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6220-1
00:40:32.101 --> 00:40:35.269
<v Kaddis, Laura J.>change. So I am holding open office hours.
Tuesdays,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6220-2
00:40:35.269 --> 00:40:38.078
<v Kaddis, Laura J.>2:00 to 2:45 PM Eastern through December
30th.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6259-0
00:40:38.078 --> 00:40:42.042
<v Kaddis, Laura J.>You can join via that team's link if you
have any questions on how to submit to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6259-1
00:40:42.042 --> 00:40:44.766
<v Kaddis, Laura J.>the Bears board.
If I don't have a lot of questions on</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6259-2
00:40:44.766 --> 00:40:47.987
<v Kaddis, Laura J.>that and you want to jump on and you have
general DUA questions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6259-3
00:40:47.987 --> 00:40:49.968
<v Kaddis, Laura J.>not specific DUI questions, if you have.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6275-0
00:40:49.968 --> 00:40:52.607
<v Kaddis, Laura J.>Those please e-mail me if you have
general DUI questions and nothing's</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6275-1
00:40:52.607 --> 00:40:53.238
<v Kaddis, Laura J.>really happening.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6276-0
00:40:53.278 --> 00:40:54.038
<v Kaddis, Laura J.>Please join.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6283-0
00:40:54.038 --> 00:40:56.278
<v Kaddis, Laura J.>Happy to chat with you and answer
questions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6287-0
00:40:56.968 --> 00:40:57.608
<v Kaddis, Laura J.>Also, as I spoke about.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6319-0
00:40:58.038 --> 00:41:01.807
<v Kaddis, Laura J.>Earlier bars University,
fantastic resource I think when I first</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6319-1
00:41:01.807 --> 00:41:06.388
<v Kaddis, Laura J.>started I spent like 3 days in my first
week just going through all the videos</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6319-2
00:41:06.388 --> 00:41:08.997
<v Kaddis, Laura J.>again like step by step,
broken down pieces.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6319-3
00:41:08.997 --> 00:41:10.678
<v Kaddis, Laura J.>The videos that really great.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6332-0
00:41:10.838 --> 00:41:13.217
<v Kaddis, Laura J.>So if you need help figure out how to
submit,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6332-1
00:41:13.217 --> 00:41:16.941
<v Kaddis, Laura J.>create a new package even to create an
account to submit a new package,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6332-2
00:41:16.941 --> 00:41:18.078
<v Kaddis, Laura J.>please check that out.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6347-0
00:41:20.528 --> 00:41:24.275
<v Kaddis, Laura J.>So these are just links to all the
documents I spoke about and some other</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6347-1
00:41:24.275 --> 00:41:24.528
<v Kaddis, Laura J.>ones.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6358-0
00:41:24.528 --> 00:41:26.735
<v Kaddis, Laura J.>So including the various submission
instructions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6358-1
00:41:26.735 --> 00:41:28.808
<v Kaddis, Laura J.>again very detailed instructions step by
step.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6369-0
00:41:29.318 --> 00:41:31.878
<v Kaddis, Laura J.>What do I do to submit a new package?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6378-0
00:41:31.918 --> 00:41:34.038
<v Kaddis, Laura J.>What do I do if Ord says changes are
needed?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6383-0
00:41:34.038 --> 00:41:35.758
<v Kaddis, Laura J.>What do I do if no changes are needed?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6396-0
00:41:35.758 --> 00:41:38.835
<v Kaddis, Laura J.>How do I submit the final executed
agreement so step by step?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6396-1
00:41:38.835 --> 00:41:41.118
<v Kaddis, Laura J.>Hopefully those are helpful if you need
them.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6407-0
00:41:42.648 --> 00:41:44.448
<v Kaddis, Laura J.>And accompanying frequently asked
questions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6420-0
00:41:44.448 --> 00:41:46.373
<v Kaddis, Laura J.>Again,
I spoke for some of them during this</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6420-1
00:41:46.373 --> 00:41:47.728
<v Kaddis, Laura J.>presentation about all of them.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6427-0
00:41:47.768 --> 00:41:50.528
<v Kaddis, Laura J.>So if you wanted to check that out,
it might also be a good resource.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6430-0
00:41:51.288 --> 00:41:51.848
<v Kaddis, Laura J.>Excuse me.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6451-0
00:41:52.528 --> 00:41:55.282
<v Kaddis, Laura J.>Also,
our research dua decision tree and CHEAT</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6451-1
00:41:55.282 --> 00:41:59.208
<v Kaddis, Laura J.>SHEET along with template instructions on
how to complete the DUA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6467-0
00:41:59.518 --> 00:42:03.637
<v Kaddis, Laura J.>The Ord DDUA templates that were released
earlier this year against Super detailed</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6467-1
00:42:03.637 --> 00:42:06.118
<v Kaddis, Laura J.>instructions step by step what needs to
go where.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6471-0
00:42:08.208 --> 00:42:08.608
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6476-0
00:42:08.608 --> 00:42:11.048
<v Kaddis, Laura J.>So if there are any questions,
I'd be happy to take those.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6484-0
00:42:15.128 --> 00:42:16.688
<v Permana, Paskasari A.>Thank you very much, Laura.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6496-0
00:42:16.688 --> 00:42:22.208
<v Permana, Paskasari A.>There was a great presentation and I am
going to share my screen.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6504-0
00:42:23.688 --> 00:42:28.728
<v Permana, Paskasari A.>Listing the questions that have been
posted in the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6509-0
00:42:30.408 --> 00:42:31.288
<v Permana, Paskasari A.>Can just bear with me.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6512-0
00:42:33.288 --> 00:42:34.168
<v Permana, Paskasari A.>All right.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6517-0
00:42:34.248 --> 00:42:37.048
<v Permana, Paskasari A.>Hopefully you all can see my screen.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6520-0
00:42:37.838 --> 00:42:39.038
<v Kaddis, Laura J.>Yes, I can.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6523-0
00:42:39.798 --> 00:42:40.318
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6546-0
00:42:40.318 --> 00:42:43.624
<v Permana, Paskasari A.>So the first question is,
before submitting the package,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6546-1
00:42:43.624 --> 00:42:48.438
<v Permana, Paskasari A.>there's no requirement for the submitter
to sign the submission package, is there?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6552-0
00:42:49.208 --> 00:42:51.156
<v Kaddis, Laura J.>Correct. Yep.
You don't need to sign this package,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6552-1
00:42:51.156 --> 00:42:51.728
<v Kaddis, Laura J.>just submit it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6555-0
00:42:52.958 --> 00:42:53.758
<v Permana, Paskasari A.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6560-0
00:42:54.238 --> 00:42:55.398
<v Permana, Paskasari A.>Next question.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6584-0
00:42:55.438 --> 00:42:58.677
<v Permana, Paskasari A.>At this time,
our site has a newly assigned</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6584-1
00:42:58.677 --> 00:43:02.798
<v Permana, Paskasari A.>representative for the TTP,
who handles Rduas and Mtas.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6592-0
00:43:03.078 --> 00:43:05.838
<v Permana, Paskasari A.>Who these persons submit for Ord review?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6605-0
00:43:06.078 --> 00:43:08.812
<v Permana, Paskasari A.>Oh, sorry,
would this person submit for Rd.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6605-1
00:43:08.812 --> 00:43:11.358
<v Permana, Paskasari A.>review and handle modifications required?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6608-0
00:43:13.038 --> 00:43:14.398
<v Kaddis, Laura J.>So they can.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6618-0
00:43:14.678 --> 00:43:17.398
<v Kaddis, Laura J.>I don't know if they'd be the best person
to submit it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6652-0
00:43:17.398 --> 00:43:20.537
<v Kaddis, Laura J.>Honestly it it could be.
Whoever your facility nominates to do</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6652-1
00:43:20.537 --> 00:43:22.779
<v Kaddis, Laura J.>that.
If if they wanted one person to handle</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6652-2
00:43:22.779 --> 00:43:24.971
<v Kaddis, Laura J.>all of them,
that's that's completely fine.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6652-3
00:43:24.971 --> 00:43:28.558
<v Kaddis, Laura J.>If they would rather someone from the
research team do it, that's fine.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6671-0
00:43:28.758 --> 00:43:31.654
<v Kaddis, Laura J.>So again,
discuss with your facility and discuss</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6671-1
00:43:31.654 --> 00:43:36.383
<v Kaddis, Laura J.>with the TTP representative and to see if
that's in their their bandwidth to do</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6671-2
00:43:36.383 --> 00:43:36.678
<v Kaddis, Laura J.>that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6713-0
00:43:39.728 --> 00:43:45.207
<v Permana, Paskasari A.>Next question is a submission to the
MTADUA Workspace Limited to the Pi or</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6673-0
00:43:40.648 --> 00:43:40.808
<v Kaddis, Laura J.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6713-1
00:43:45.207 --> 00:43:50.027
<v Permana, Paskasari A.>study team. Local R&amp;
D Staffs for such as or that is AO would</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6713-2
00:43:50.027 --> 00:43:54.848
<v Permana, Paskasari A.>be unable to upload agreement into a
package on behalf of the Pi.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6723-0
00:43:56.918 --> 00:43:59.198
<v Kaddis, Laura J.>So Nope, it's not limited to anyone.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6740-0
00:43:59.238 --> 00:44:02.150
<v Kaddis, Laura J.>Anyone specific?
Anyone can submit a package again whoever</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6740-1
00:44:02.150 --> 00:44:04.765
<v Kaddis, Laura J.>you want from your,
from your facility to submit it,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6740-2
00:44:04.765 --> 00:44:05.998
<v Kaddis, Laura J.>they are able to do that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6748-0
00:44:09.788 --> 00:44:12.877
<v Permana, Paskasari A.>Next question,
how long do you think the entire process</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6748-1
00:44:12.877 --> 00:44:13.428
<v Permana, Paskasari A.>will take?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6785-0
00:44:15.578 --> 00:44:20.450
<v Kaddis, Laura J.>I'm gonna make an assumption that the
entire process means the submission from</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6785-1
00:44:20.450 --> 00:44:25.075
<v Kaddis, Laura J.>the submission of the agreement to
getting it the final return so that you</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6785-2
00:44:25.075 --> 00:44:27.418
<v Kaddis, Laura J.>can get signatures so it varies again.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6796-0
00:44:27.418 --> 00:44:31.498
<v Kaddis, Laura J.>It'll depend on how extensive the
modifications are.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6812-0
00:44:31.538 --> 00:44:36.498
<v Kaddis, Laura J.>If OGC Star and and or TTP reviewer
needed, if there's a foreign entity.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6838-0
00:44:36.498 --> 00:44:39.385
<v Kaddis, Laura J.>If if United States trade representative
reviews are needed,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6838-1
00:44:39.385 --> 00:44:43.171
<v Kaddis, Laura J.>so honestly I can't give you an answer,
we all try our hardest to get them back</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6838-2
00:44:43.171 --> 00:44:44.448
<v Kaddis, Laura J.>to you as soon as possible.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6852-0
00:44:44.558 --> 00:44:49.005
<v Kaddis, Laura J.>But depending on what offices are
involved and have to review the timeline</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6852-1
00:44:49.005 --> 00:44:49.598
<v Kaddis, Laura J.>does vary.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6855-0
00:44:51.848 --> 00:44:52.528
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6892-0
00:44:54.008 --> 00:44:58.981
<v Permana, Paskasari A.>Does creating a new project just for DOA
reviews when the project already exists</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6892-1
00:44:58.981 --> 00:45:02.295
<v Permana, Paskasari A.>in IB net for the regular Research
Committee reviews,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6892-2
00:45:02.295 --> 00:45:06.408
<v Permana, Paskasari A.>create project application and distort
our site's project numbers?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6911-0
00:45:08.318 --> 00:45:12.226
<v Kaddis, Laura J.>So if your project is already in IRB net,
you won't create a new project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6911-1
00:45:12.226 --> 00:45:15.078
<v Kaddis, Laura J.>You will create a new package,
but not a new project.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6934-0
00:45:15.078 --> 00:45:18.964
<v Kaddis, Laura J.>So just you'll go back to your existing
project and just start a new package in</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6934-1
00:45:18.964 --> 00:45:21.490
<v Kaddis, Laura J.>that project.
So it should not distort your project</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6934-2
00:45:21.490 --> 00:45:21.878
<v Kaddis, Laura J.>numbers.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6938-0
00:45:23.378 --> 00:45:24.178
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6943-0
00:45:24.578 --> 00:45:27.178
<v Permana, Paskasari A.>When is this process going to be required?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6968-0
00:45:28.818 --> 00:45:31.961
<v Kaddis, Laura J.>Still,
I want to emphasize again that the only</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6968-1
00:45:31.961 --> 00:45:37.310
<v Kaddis, Laura J.>change in the process is how duas and
Mtas that need our D review are submitted</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6968-2
00:45:37.310 --> 00:45:37.778
<v Kaddis, Laura J.>to Ord.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6982-0
00:45:38.338 --> 00:45:41.906
<v Kaddis, Laura J.>So it's not a big change but it,
but it will be required starting January</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/6982-1
00:45:41.906 --> 00:45:42.098
<v Kaddis, Laura J.>1st.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7009-0
00:45:42.098 --> 00:45:46.538
<v Kaddis, Laura J.>So if you have an MTA or DUA,
research at DI Dua that your research</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7009-1
00:45:46.538 --> 00:45:50.978
<v Kaddis, Laura J.>office or other agreements authority has
stated need some DUI help.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7023-0
00:45:51.018 --> 00:45:56.288
<v Kaddis, Laura J.>I need some Ord help then those ones will
be submitted to Bers starting January 1st.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7029-0
00:45:56.878 --> 00:45:58.118
<v Kaddis, Laura J.>Until then, you can start now.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7036-0
00:45:58.118 --> 00:46:00.002
<v Kaddis, Laura J.>Everyone,
everyone has access to the board.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7036-1
00:46:00.002 --> 00:46:01.158
<v Kaddis, Laura J.>Can start now. Soft launch.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7044-0
00:46:02.608 --> 00:46:03.888
<v Kaddis, Laura J.>Otherwise you can just e-mail.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7069-0
00:46:03.928 --> 00:46:08.676
<v Kaddis, Laura J.>Continue to e-mail the CPNR Ord Reg
Affairs Research agreement address e-mail</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7069-1
00:46:08.676 --> 00:46:11.415
<v Kaddis, Laura J.>address,
which I cited a couple times in the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7069-2
00:46:11.415 --> 00:46:13.728
<v Kaddis, Laura J.>presentation so you can find it there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7071-0
00:46:16.078 --> 00:46:16.438
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7077-0
00:46:18.448 --> 00:46:19.328
<v Permana, Paskasari A.>If the DUA.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7097-0
00:46:19.328 --> 00:46:21.876
<v Permana, Paskasari A.>MTA does not require or the consultation
does.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7097-1
00:46:21.876 --> 00:46:25.128
<v Permana, Paskasari A.>The fully executed agreement still get
uploaded into via S?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7104-0
00:46:26.938 --> 00:46:28.378
<v Kaddis, Laura J.>So no, not at this time.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7123-0
00:46:28.378 --> 00:46:31.017
<v Kaddis, Laura J.>So if Ord is not involved in your
agreement,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7123-1
00:46:31.017 --> 00:46:34.418
<v Kaddis, Laura J.>you don't need to upload the fully
executed one in bears.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7141-0
00:46:34.458 --> 00:46:39.719
<v Kaddis, Laura J.>It should be filed at your site per our
records control schedule and for your per</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7141-1
00:46:39.719 --> 00:46:41.258
<v Kaddis, Laura J.>your facility processes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7145-0
00:46:44.148 --> 00:46:45.188
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7152-0
00:46:45.188 --> 00:46:46.828
<v Permana, Paskasari A.>Who is considered the data custodian?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7162-0
00:46:48.458 --> 00:46:50.418
<v Kaddis, Laura J.>So I touched on this one a little earlier.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7174-0
00:46:50.538 --> 00:46:53.618
<v Kaddis, Laura J.>So the data custodian is more or less the
keeper of the data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7201-0
00:46:53.618 --> 00:46:56.363
<v Kaddis, Laura J.>So they're kind of the ones they may have
originated,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7201-1
00:46:56.363 --> 00:47:00.481
<v Kaddis, Laura J.>the data they may for something like CSP,
they may have funded the collection of</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7201-2
00:47:00.481 --> 00:47:00.938
<v Kaddis, Laura J.>the data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7219-0
00:47:01.578 --> 00:47:06.839
<v Kaddis, Laura J.>So it's really like a person or entity or
program office responsible for the data</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7219-1
00:47:06.839 --> 00:47:08.378
<v Kaddis, Laura J.>who is in control of it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7236-0
00:47:08.378 --> 00:47:11.818
<v Kaddis, Laura J.>So they they they have the authority to
say yes or no, you can't share this data.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7238-0
00:47:11.818 --> 00:47:13.378
<v Kaddis, Laura J.>They're considered the data custodian.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7239-0
00:47:15.098 --> 00:47:15.258
<v Permana, Paskasari A.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7266-0
00:47:17.038 --> 00:47:22.139
<v Permana, Paskasari A.>Details of data transfer would be found
in the ERDSP, right?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7266-1
00:47:22.139 --> 00:47:28.409
<v Permana, Paskasari A.>Ergo would go to Orr for review or
approval per the new process for ERD SB</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7266-2
00:47:28.409 --> 00:47:29.078
<v Permana, Paskasari A.>reviews.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7281-0
00:47:31.328 --> 00:47:33.695
<v Kaddis, Laura J.>Again,
I'm going to make an assumption here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7281-1
00:47:33.695 --> 00:47:36.008
<v Kaddis, Laura J.>If I'm wrong,
please put Marfo in the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7302-0
00:47:36.128 --> 00:47:42.295
<v Kaddis, Laura J.>My assumption here is that maybe you're
stating that the with the DUA need isso</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7302-1
00:47:42.295 --> 00:47:43.528
<v Kaddis, Laura J.>or or or review.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7315-0
00:47:44.128 --> 00:47:47.848
<v Kaddis, Laura J.>Currently there are no changes we're
aware of to the duas.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7322-0
00:47:47.848 --> 00:47:50.928
<v Kaddis, Laura J.>They're still being reviewed at the
facility level.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7344-0
00:47:50.928 --> 00:47:53.591
<v Kaddis, Laura J.>If that changes,
we will communicate that to the field,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7344-1
00:47:53.591 --> 00:47:56.111
<v Kaddis, Laura J.>but right now duas are are separate from
the ER DSP.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7344-2
00:47:56.111 --> 00:47:58.488
<v Kaddis, Laura J.>Then they will be reviewed at the
facility level.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7368-0
00:47:59.628 --> 00:48:03.904
<v Kaddis, Laura J.>Unless I think there there are some
circumstances where maybe sometimes</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7368-1
00:48:03.904 --> 00:48:08.595
<v Kaddis, Laura J.>central IRB, the central issso reviews,
but you'll I think you'll know if your</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7368-2
00:48:08.595 --> 00:48:09.188
<v Kaddis, Laura J.>site uses.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7380-0
00:48:10.728 --> 00:48:13.128
<v Kaddis, Laura J.>If your site's required to submit to the
central IRB.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7390-0
00:48:13.608 --> 00:48:17.288
<v Kaddis, Laura J.>If not, please contact whatever IRB,
or if you're, if you do, sorry.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7421-0
00:48:17.688 --> 00:48:22.222
<v Kaddis, Laura J.>If you do submit to the central IRB and
you're not sure if the central issso or</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7421-1
00:48:22.222 --> 00:48:24.715
<v Kaddis, Laura J.>your facility isso needs to review the
DUA,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7421-2
00:48:24.715 --> 00:48:27.888
<v Kaddis, Laura J.>please speak with the central ISSO and
check with them.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7423-0
00:48:29.618 --> 00:48:29.978
<v Permana, Paskasari A.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7438-0
00:48:31.408 --> 00:48:35.808
<v Permana, Paskasari A.>The next questions I believe have been
already been responded to.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7443-0
00:48:35.808 --> 00:48:37.368
<v Permana, Paskasari A.>I can just read this quickly.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7479-0
00:48:37.528 --> 00:48:43.066
<v Permana, Paskasari A.>Our isssss moving to national level for
research rather than being assigned to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7479-1
00:48:43.066 --> 00:48:48.745
<v Permana, Paskasari A.>the facility and the person did actually
respond by saying by writing that OR is</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7479-2
00:48:48.745 --> 00:48:51.268
<v Permana, Paskasari A.>making a transition from local to O.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7505-0
00:48:51.258 --> 00:48:56.348
<v Permana, Paskasari A.>RRISSO reviews for ERDSPS for non ERDSP
functions local ISSO may still be</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7505-1
00:48:56.348 --> 00:48:59.168
<v Permana, Paskasari A.>available for consultation and functions.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7520-0
00:48:59.968 --> 00:49:05.288
<v Permana, Paskasari A.>And somebody did ask to get a link to the
power app that contains the decision tree.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7553-0
00:49:05.528 --> 00:49:11.331
<v Permana, Paskasari A.>And I put the link to find Pro app as
well as their direct link to the decision</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7553-1
00:49:11.331 --> 00:49:16.408
<v Permana, Paskasari A.>tree in find Pro which is also in the
slide deck of the presentation.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7561-0
00:49:17.008 --> 00:49:20.808
<v Permana, Paskasari A.>And I'm just going to copy this link
again.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7566-0
00:49:20.808 --> 00:49:23.408
<v Permana, Paskasari A.>Also,
this is more information on find pro.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7568-0
00:49:25.408 --> 00:49:25.928
<v Permana, Paskasari A.>Sorry.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7575-0
00:49:27.738 --> 00:49:29.210
<v Permana, Paskasari A.>OK,
I thought somebody was going to say</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7575-1
00:49:29.210 --> 00:49:29.578
<v Permana, Paskasari A.>something.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7616-0
00:49:31.298 --> 00:49:36.992
<v Permana, Paskasari A.>The next question for projects where the
VA is the recipient of the data and the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7616-1
00:49:36.992 --> 00:49:40.718
<v Permana, Paskasari A.>data disclosing entity requires ADUA to
be executed,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7616-2
00:49:40.718 --> 00:49:43.178
<v Permana, Paskasari A.>which usually is a non VA template.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7627-0
00:49:43.418 --> 00:49:47.814
<v Permana, Paskasari A.>Do we submit this non VA template to
ordinary via via S or e-mail group for</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7627-1
00:49:47.814 --> 00:49:48.218
<v Permana, Paskasari A.>review?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7641-0
00:49:50.538 --> 00:49:53.416
<v Kaddis, Laura J.>So again,
so your local research agreements</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7641-1
00:49:53.416 --> 00:49:55.378
<v Kaddis, Laura J.>authority should review first.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7675-0
00:49:56.858 --> 00:49:59.870
<v Kaddis, Laura J.>I know it's a little less clear versus a
VA template,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7675-1
00:49:59.870 --> 00:50:04.220
<v Kaddis, Laura J.>but if there's anything that sticks out
to the reviewer as as funky regarding</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7675-2
00:50:04.220 --> 00:50:07.231
<v Kaddis, Laura J.>like policy or legal issues or
intellectual property,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7675-3
00:50:07.231 --> 00:50:10.521
<v Kaddis, Laura J.>it's less likely there will be policy
issues. Cause again,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7675-4
00:50:10.521 --> 00:50:12.138
<v Kaddis, Laura J.>we don't have a lot of polic.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7694-0
00:50:12.138 --> 00:50:15.963
<v Kaddis, Laura J.>For receiving data,
but if there's something that like,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7694-1
00:50:15.963 --> 00:50:19.446
<v Kaddis, Laura J.>Oh well,
we will own any patented thing that comes</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7694-2
00:50:19.446 --> 00:50:20.538
<v Kaddis, Laura J.>out of anything.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7711-0
00:50:21.128 --> 00:50:25.925
<v Kaddis, Laura J.>That the VA does with this data, anything,
anything that might raise some questions,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7711-1
00:50:25.925 --> 00:50:28.408
<v Kaddis, Laura J.>then yes,
those can come to Ord definitely.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7720-0
00:50:28.408 --> 00:50:30.728
<v Kaddis, Laura J.>But if you can resolve it at the site
level, that's great.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7723-0
00:50:30.928 --> 00:50:32.208
<v Kaddis, Laura J.>If not already here to help.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7732-0
00:50:33.918 --> 00:50:37.438
<v Permana, Paskasari A.>Thank you. And I think Doctor Stone also.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7763-0
00:50:39.418 --> 00:50:48.089
<v Permana, Paskasari A.>Made more comments to the question on the
details of the data transfer in ERDSP,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7763-1
00:50:48.089 --> 00:50:54.618
<v Permana, Paskasari A.>so I'm putting that in the under that
question and the next.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7764-0
00:50:54.248 --> 00:50:55.728
<v Kaddis, Laura J.>Oh, thank you. Thanks for that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7776-0
00:50:57.158 --> 00:51:02.678
<v Permana, Paskasari A.>The next question that I'm also just
going to copy and.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7779-0
00:51:04.418 --> 00:51:04.738
<v Permana, Paskasari A.>Into this.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7800-0
00:51:06.578 --> 00:51:11.648
<v Permana, Paskasari A.>Is is there an effective date for the
transition from local to orriss or</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7800-1
00:51:11.648 --> 00:51:12.898
<v Permana, Paskasari A.>reviews of Ardsps?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7807-0
00:51:15.158 --> 00:51:17.078
<v Kaddis, Laura J.>So I see Howard has answered that as well.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7814-0
00:51:16.738 --> 00:51:18.098
<v Permana, Paskasari A.>Yes, yes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7811-0
00:51:17.438 --> 00:51:17.998
<v Kaddis, Laura J.>He's very fast.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7816-0
00:51:17.998 --> 00:51:18.638
<v Kaddis, Laura J.>Thank you, Howard.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7823-0
00:51:18.758 --> 00:51:20.878
<v Kaddis, Laura J.>The tradition date is still PVD when.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7822-0
00:51:19.898 --> 00:51:20.098
<v Permana, Paskasari A.>Exactly.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7830-0
00:51:21.078 --> 00:51:23.718
<v Kaddis, Laura J.>Yeah, when Orr lets us know,
we'll let you know.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7841-0
00:51:24.198 --> 00:51:27.758
<v Kaddis, Laura J.>We often find out things in real time.
The same time you are like we do.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7842-0
00:51:27.838 --> 00:51:29.238
<v Kaddis, Laura J.>We do, unfortunately.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7855-0
00:51:29.318 --> 00:51:32.558
<v Kaddis, Laura J.>Or maybe sadly don't have,
don't get a lot of advance notice.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7874-0
00:51:32.558 --> 00:51:34.329
<v Kaddis, Laura J.>Sometimes we don't get every once in
awhile,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7874-1
00:51:34.329 --> 00:51:37.595
<v Kaddis, Laura J.>I'll get a notice that the field received
from a different program office and they</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7874-2
00:51:37.595 --> 00:51:39.798
<v Kaddis, Laura J.>ask me questions about it and I did not
receive it. So.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7879-0
00:51:40.498 --> 00:51:41.458
<v Kaddis, Laura J.>Sometimes you know things before we do.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7880-0
00:51:44.318 --> 00:51:44.838
<v Permana, Paskasari A.>Correct.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7887-0
00:51:47.208 --> 00:51:50.848
<v Permana, Paskasari A.>So there is the next question.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7895-0
00:51:52.378 --> 00:51:53.458
<v Permana, Paskasari A.>Such a release, OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7902-0
00:51:53.498 --> 00:51:56.778
<v Permana, Paskasari A.>Let me put this here so everybody can
also actually see it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7925-0
00:52:00.468 --> 00:52:06.736
<v Permana, Paskasari A.>So the release of information must be
reviewed both by local issso and by Orr</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7925-1
00:52:06.736 --> 00:52:09.548
<v Permana, Paskasari A.>when they review the ERDSP correct?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7950-0
00:52:11.188 --> 00:52:15.351
<v Kaddis, Laura J.>So current policy which I I can't think
of it off the top of my head when I will</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7950-1
00:52:15.351 --> 00:52:17.868
<v Kaddis, Laura J.>type answers to these and I'll cite it in
there.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7969-0
00:52:17.908 --> 00:52:22.262
<v Kaddis, Laura J.>Current policy is at the local ISSO needs
to be involved in the creation of the DUA</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/7969-1
00:52:22.262 --> 00:52:23.868
<v Kaddis, Laura J.>like the data transfer request.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8007-0
00:52:25.618 --> 00:52:30.252
<v Kaddis, Laura J.>How involved they need to be is up to
your facilities processes,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8007-1
00:52:30.252 --> 00:52:36.098
<v Kaddis, Laura J.>so I know DU as reviewed by Orr that need
to be signed by those those central ISS</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8007-2
00:52:36.098 --> 00:52:39.234
<v Kaddis, Laura J.>OS.
Whether your facility requires both the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8007-3
00:52:39.234 --> 00:52:40.018
<v Kaddis, Laura J.>local ISSO.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8015-0
00:52:40.608 --> 00:52:42.928
<v Kaddis, Laura J.>And central SSL to sign it,
then that's up to your facility.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8024-0
00:52:42.928 --> 00:52:45.916
<v Kaddis, Laura J.>I don't think I've heard of that,
but your facility may do that if they</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8024-1
00:52:45.916 --> 00:52:46.248
<v Kaddis, Laura J.>want to.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8033-0
00:52:46.648 --> 00:52:48.956
<v Kaddis, Laura J.>But again,
like the local ISSL needs to be involved</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8033-1
00:52:48.956 --> 00:52:49.488
<v Kaddis, Laura J.>in some way.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8037-0
00:52:51.478 --> 00:52:51.638
<v Permana, Paskasari A.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8041-0
00:52:51.678 --> 00:52:53.598
<v Permana, Paskasari A.>All right.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8047-0
00:52:53.598 --> 00:52:56.598
<v Permana, Paskasari A.>I think that is the last question that I
see in the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8060-0
00:52:58.338 --> 00:53:01.458
<v Permana, Paskasari A.>And yeah, Howard has a.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8067-0
00:52:58.748 --> 00:53:01.084
<v Kaddis, Laura J.>Oh wait,
Howard's Howard's adding some more</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8067-1
00:53:01.084 --> 00:53:03.951
<v Kaddis, Laura J.>information.
He he has all the information on the Orr</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8067-2
00:53:03.951 --> 00:53:04.428
<v Kaddis, Laura J.>transfer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8074-0
00:53:04.428 --> 00:53:07.548
<v Kaddis, Laura J.>So please anything he says take what he
says.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8070-0
00:53:05.408 --> 00:53:05.808
<v Permana, Paskasari A.>Yeah.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8090-0
00:53:09.218 --> 00:53:11.135
<v Kaddis, Laura J.>Yeah,
so so Howard says Orr wants to minimize</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8081-0
00:53:09.758 --> 00:53:10.118
<v Permana, Paskasari A.>Oh.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8090-1
00:53:11.135 --> 00:53:13.218
<v Kaddis, Laura J.>the human touch and reduce the number of
reviews.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8112-0
00:53:13.218 --> 00:53:18.875
<v Kaddis, Laura J.>So RR wants to move to a single ISSO
review with Orr to do those reviews again</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8112-1
00:53:18.875 --> 00:53:20.378
<v Kaddis, Laura J.>after the transition.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8132-0
00:53:21.018 --> 00:53:23.797
<v Kaddis, Laura J.>So more details will be coming on that,
but for now,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8132-1
00:53:23.797 --> 00:53:26.418
<v Kaddis, Laura J.>So what I speak on is what's happening
right now.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8135-0
00:53:26.418 --> 00:53:28.658
<v Kaddis, Laura J.>So hopefully when when more things change.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8146-0
00:53:28.968 --> 00:53:31.540
<v Kaddis, Laura J.>Because you know,
that's all we need for this year is more</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8146-1
00:53:31.540 --> 00:53:31.888
<v Kaddis, Laura J.>changes.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8158-0
00:53:32.208 --> 00:53:35.487
<v Kaddis, Laura J.>Obviously we will communicate everything
we can as soon as we as soon as we know</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8158-1
00:53:35.487 --> 00:53:35.608
<v Kaddis, Laura J.>it.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8162-0
00:53:38.138 --> 00:53:38.298
<v Permana, Paskasari A.>OK.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8165-0
00:53:38.898 --> 00:53:42.138
<v Permana, Paskasari A.>So the next question is.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8168-0
00:53:43.778 --> 00:53:45.138
<v Permana, Paskasari A.>And I'm putting this here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8184-0
00:53:49.628 --> 00:53:54.988
<v Permana, Paskasari A.>Is that training available for first line
IE facility reviewers of agreements?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8190-0
00:53:57.888 --> 00:53:59.368
<v Kaddis, Laura J.>Currently, but I will.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8206-0
00:53:59.448 --> 00:54:03.308
<v Kaddis, Laura J.>I do have plans for future trainings,
so I will keep that in mind as one of my</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8206-1
00:54:03.308 --> 00:54:06.288
<v Kaddis, Laura J.>next ones for sure. 'cause,
I know that it's very important.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8215-0
00:54:06.288 --> 00:54:08.888
<v Kaddis, Laura J.>I know there's been a lot of changes and
turnover and stuff.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8221-0
00:54:08.888 --> 00:54:10.488
<v Kaddis, Laura J.>I know some people who are handling the
agreements.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8241-0
00:54:10.488 --> 00:54:13.266
<v Kaddis, Laura J.>Sometimes I never looked at the
agreements like anything like these</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8241-1
00:54:13.266 --> 00:54:15.717
<v Kaddis, Laura J.>agreements before,
so I know it's very important to get out</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8241-2
00:54:15.717 --> 00:54:16.248
<v Kaddis, Laura J.>to the field.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8244-0
00:54:16.248 --> 00:54:17.368
<v Kaddis, Laura J.>So I will work on that.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8247-0
00:54:17.728 --> 00:54:19.048
<v Kaddis, Laura J.>Thank you for that suggestion.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8251-0
00:54:20.808 --> 00:54:24.008
<v Permana, Paskasari A.>Thank you. And I oh.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8258-0
00:54:26.458 --> 00:54:30.738
<v Permana, Paskasari A.>It's like another question is trickled in
on the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8271-0
00:54:32.538 --> 00:54:36.978
<v Permana, Paskasari A.>Am I understanding that all erds PS for
all facilities?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8276-0
00:54:38.538 --> 00:54:39.018
<v Permana, Paskasari A.>All studies.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8277-0
00:54:39.018 --> 00:54:39.498
<v Permana, Paskasari A.>Oops, sorry.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8279-0
00:54:42.218 --> 00:54:42.778
<v Permana, Paskasari A.>That's wrong.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8294-0
00:54:44.458 --> 00:54:50.138
<v Permana, Paskasari A.>Are going to transition to centralized
assess review and the Howard did answer.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8297-0
00:54:50.408 --> 00:54:52.888
<v Permana, Paskasari A.>Yes, that is correct.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8304-0
00:54:53.008 --> 00:54:55.768
<v Permana, Paskasari A.>Details are being ironed out by Orr.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8318-0
00:54:57.288 --> 00:55:02.128
<v Permana, Paskasari A.>So I'll put that also in here,
but you all can see it in the chat also.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8330-0
00:55:07.298 --> 00:55:11.218
<v Permana, Paskasari A.>And there is another question just I
guess for confirmation.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8331-0
00:55:12.658 --> 00:55:13.178
<v Permana, Paskasari A.>Are.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8343-0
00:55:15.748 --> 00:55:18.076
<v Permana, Paskasari A.>Sorry,
I'm trying to keep up with these</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8343-1
00:55:18.076 --> 00:55:18.948
<v Permana, Paskasari A.>questions here.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8342-0
00:55:18.488 --> 00:55:19.208
<v Kaddis, Laura J.>Yeah, no worries.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8344-0
00:55:19.208 --> 00:55:20.248
<v Kaddis, Laura J.>They're coming in very fast.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8365-0
00:55:22.978 --> 00:55:26.837
<v Permana, Paskasari A.>We process multiple MTA duas.
Our current process does not need to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8365-1
00:55:26.837 --> 00:55:29.658
<v Permana, Paskasari A.>change until January 1st, 2026.
Is this correct?</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8407-0
00:55:32.408 --> 00:55:36.127
<v Kaddis, Laura J.>Correct. So and the again,
the only process that is changing is</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8407-1
00:55:36.127 --> 00:55:40.717
<v Kaddis, Laura J.>those Mtas and duas that need Ord review
instead of them being emailed to Ord,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8407-2
00:55:40.717 --> 00:55:44.668
<v Kaddis, Laura J.>they'll be submitted in there.
So does not change any of your other</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8407-3
00:55:44.668 --> 00:55:47.457
<v Kaddis, Laura J.>processes.
If it's something that you typically</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8407-4
00:55:47.457 --> 00:55:48.328
<v Kaddis, Laura J.>handle at your.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8421-0
00:55:48.328 --> 00:55:52.888
<v Kaddis, Laura J.>Site level that there's no changes or
questionable changes that need Ord review.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8424-0
00:55:52.928 --> 00:55:55.168
<v Kaddis, Laura J.>Nothing is changing for that that
agreement.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8427-0
00:55:55.168 --> 00:55:56.648
<v Kaddis, Laura J.>So again, it's only when you need.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8435-0
00:55:57.578 --> 00:56:00.898
<v Kaddis, Laura J.>Ord review on an agreement which Ord does
not review all agreements.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8438-0
00:56:03.888 --> 00:56:04.528
<v Permana, Paskasari A.>Sounds good.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8449-0
00:56:06.338 --> 00:56:12.378
<v Permana, Paskasari A.>And I think that is all the questions in
the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8460-0
00:56:14.458 --> 00:56:18.378
<v Permana, Paskasari A.>I know we are coming up to the end of the
hour.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8472-0
00:56:20.178 --> 00:56:25.458
<v Permana, Paskasari A.>So I'm going to give it just a few more
seconds.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8489-0
00:56:27.298 --> 00:56:33.298
<v Permana, Paskasari A.>To see if there are any other questions,
but if not, I do want to thank Laura.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8508-0
00:56:33.728 --> 00:56:37.388
<v Permana, Paskasari A.>And Howard, obviously for the present,
a great presentation.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8508-1
00:56:37.388 --> 00:56:41.288
<v Permana, Paskasari A.>You can see a lot of people really
appreciate this presentation.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8530-0
00:56:41.288 --> 00:56:46.161
<v Permana, Paskasari A.>I think it's a great presentation and
also I want to ask the attendees to</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8530-1
00:56:46.161 --> 00:56:49.848
<v Permana, Paskasari A.>please take a couple of minutes to
complete the survey.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8539-0
00:56:50.128 --> 00:56:54.248
<v Permana, Paskasari A.>Provide your feedback because this that
will really help us in.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8558-0
00:56:56.178 --> 00:57:01.341
<v Permana, Paskasari A.>Planning for future webinars also,
as well as getting feedback on how we can</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8558-1
00:57:01.341 --> 00:57:03.218
<v Permana, Paskasari A.>do better otherwise and the.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8570-0
00:57:05.448 --> 00:57:10.848
<v Permana, Paskasari A.>Training material will be available at
the TinyURL that I put also in the chat.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8594-0
00:57:12.338 --> 00:57:16.686
<v Permana, Paskasari A.>Archive of their webinars can be found
also in the E Pros Webinar archive and</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8594-1
00:57:16.686 --> 00:57:17.578
<v Permana, Paskasari A.>just wait a few.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8618-0
00:57:17.578 --> 00:57:20.359
<v Permana, Paskasari A.>You know,
maybe a couple of days for the</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8618-1
00:57:20.359 --> 00:57:25.378
<v Permana, Paskasari A.>availability of the recording into this
folder because it will have to be</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8618-2
00:57:25.378 --> 00:57:28.498
<v Permana, Paskasari A.>processed first before being put in a
folder.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8628-0
00:57:28.498 --> 00:57:33.378
<v Permana, Paskasari A.>So other than that, again,
thank you everybody who have you know.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8643-0
00:57:34.528 --> 00:57:37.928
<v Permana, Paskasari A.>Attended the this webinar and also gave
us great.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8649-0
00:57:37.928 --> 00:57:40.568
<v Permana, Paskasari A.>You know,
great questions to the presenters again.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8651-0
00:57:40.568 --> 00:57:41.408
<v Permana, Paskasari A.>Thank you, Laura.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8655-0
00:57:42.628 --> 00:57:43.028
<v Kaddis, Laura J.>No problem.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8658-0
00:57:43.028 --> 00:57:43.348
<v Kaddis, Laura J.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8662-0
00:57:43.348 --> 00:57:44.788
<v Kaddis, Laura J.>Thank you all for attending again.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8682-0
00:57:44.788 --> 00:57:46.989
<v Kaddis, Laura J.>Thanks for bearing with us.
With all these changes,</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8682-1
00:57:46.989 --> 00:57:50.247
<v Kaddis, Laura J.>ones that we are in control of and not in
control of as we navigate them all</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8682-2
00:57:50.247 --> 00:57:50.628
<v Kaddis, Laura J.>together.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8695-0
00:57:50.628 --> 00:57:53.548
<v Kaddis, Laura J.>So thank you and happy Thanksgiving to
all of you and your families as well.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8705-0
00:57:54.868 --> 00:57:56.508
<v Permana, Paskasari A.>Yes, thank you everybody.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8716-0
00:57:58.418 --> 00:57:58.778
<v Johnson, Lakeeda R.>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/8723-0
00:57:59.428 --> 00:58:00.228
<v Ahluwalia, Amrita>Thank you.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/9290-0
02:13:36.458 --> 02:13:37.738
<v Turner, Cassandra D. (KCVA)>It's still 1:00.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/9291-0
02:13:37.978 --> 02:13:39.378
<v Turner, Cassandra D. (KCVA)>See some different people.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/9296-0
02:13:40.898 --> 02:13:42.418
<v Turner, Cassandra D. (KCVA)>Well, he said. One, it's two.</v>

4df9c87a-30ed-4905-a501-afb8924a8d8e/9298-0
02:13:47.418 --> 02:13:48.098
<v Turner, Cassandra D. (KCVA)>Hello.</v>