WEBVTT

abbb3964-d783-48bb-b68c-e1eb4f43fd8e-0
00:00:00.040 --> 00:00:04.483
How to navigate the study workspace This
is the central hub for any submission in

abbb3964-d783-48bb-b68c-e1eb4f43fd8e-1
00:00:04.483 --> 00:00:05.080
the system.

4e89e3d4-700a-4c11-86c1-bcc91d443fee-0
00:00:05.840 --> 00:00:08.773
Anytime you open a submission,
regardless of the type,

4e89e3d4-700a-4c11-86c1-bcc91d443fee-1
00:00:08.773 --> 00:00:10.480
you're looking at its workspace.

71a80b38-e5f5-4a22-83d1-5d7c220da269-0
00:00:11.680 --> 00:00:14.697
Let's look at the features that are
unique to the workspace,

71a80b38-e5f5-4a22-83d1-5d7c220da269-1
00:00:14.697 --> 00:00:16.280
starting with the current state.

99a2fcf1-50de-4f7d-a023-6a622c7f254e-0
00:00:17.600 --> 00:00:20.840
This flag shows the study's present
status at a glance.

b5158b23-8f0e-4e64-8ae8-fad0cf4d6b09-0
00:00:21.480 --> 00:00:24.151
Below it,
the entered IRB field records the date

b5158b23-8f0e-4e64-8ae8-fad0cf4d6b09-1
00:00:24.151 --> 00:00:27.640
and time the study was submitted by the
principal investigator.

34ad63b3-10d2-4a02-aa9e-a3d946a9040b-0
00:00:28.880 --> 00:00:33.925
You'll also see a series of important
dates here, the initial approval date,

34ad63b3-10d2-4a02-aa9e-a3d946a9040b-1
00:00:33.925 --> 00:00:38.445
the initial effective date,
the date the approval becomes effective,

34ad63b3-10d2-4a02-aa9e-a3d946a9040b-2
00:00:38.445 --> 00:00:42.966
and the approval end date,
which is the the last day the approval is

34ad63b3-10d2-4a02-aa9e-a3d946a9040b-3
00:00:42.966 --> 00:00:43.360
valid.

310a866a-87ce-45b3-887b-1fefa159b2fe-0
00:00:44.160 --> 00:00:48.600
If a study is going to continue,
a continuing review must be filed before

310a866a-87ce-45b3-887b-1fefa159b2fe-1
00:00:48.600 --> 00:00:49.200
this date.

8236cd92-eb64-491b-a39d-2757dbdefaf9-0
00:00:50.480 --> 00:00:53.337
Finally,
the last updated field reflects when the

8236cd92-eb64-491b-a39d-2757dbdefaf9-1
00:00:53.337 --> 00:00:55.680
most recent change was made to the study.

e3f188d2-b48a-4670-aba8-ebb56709f706-0
00:00:57.400 --> 00:00:59.240
Next up is the summary review here.

a594d9a7-34ed-4236-b079-ac93add94fbc-0
00:01:00.200 --> 00:01:02.840
This is a quick reference snapshot of
your submissions.

c1aa5aa5-e6ea-4de4-a01d-51bd80a089b8-0
00:01:02.840 --> 00:01:03.760
Key details.

d3c57bbc-97c7-4f4f-b4a9-2dad4dec4dc4-0
00:01:04.920 --> 00:01:07.600
The study number and title are visible at
the top.

f4520c2b-b169-4de3-8933-5433c9eca616-0
00:01:08.920 --> 00:01:12.499
The title is entered by the researcher
who creates the study,

f4520c2b-b169-4de3-8933-5433c9eca616-1
00:01:12.499 --> 00:01:15.560
and the principal investigator is listed
just below.

e24275fd-05d4-4296-9ca4-7c645d92851b-0
00:01:15.560 --> 00:01:18.760
Here you'll also see the submission type.

76a54985-95fc-4032-a94e-ef4de261a9f9-0
00:01:19.800 --> 00:01:24.597
The primary contact is assigned by the Pi
and is responsible for receiving all

76a54985-95fc-4032-a94e-ef4de261a9f9-1
00:01:24.597 --> 00:01:26.480
communications about the study.

4811451d-1cf7-4562-bc5e-cb3a3d787278-0
00:01:27.240 --> 00:01:30.282
By default,
this is the person who creates the study,

4811451d-1cf7-4562-bc5e-cb3a3d787278-1
00:01:30.282 --> 00:01:32.480
but the Pi can change this at any time.

2c1d6ed4-0f25-4bab-aa88-0a83dc13deb0-0
00:01:34.080 --> 00:01:37.840
If API Proxy has been designated,
they'll appear here as well.

1c47a7c5-fcc7-44ee-a7a6-47a4f3bc3bcc-0
00:01:39.080 --> 00:01:42.120
The IRB office handling the submission is
shown here.

1b77b2f6-25aa-41ef-949a-f96229197661-0
00:01:42.120 --> 00:01:46.560
The IRB Coordinator is the staff person
managing the submission.

15beda2f-9d18-404f-8188-ae59020cef1a-0
00:01:47.840 --> 00:01:51.784
The letter field will display a link to
the determination letter for active

15beda2f-9d18-404f-8188-ae59020cef1a-1
00:01:51.784 --> 00:01:52.200
studies.

818a32b4-3579-4f35-b578-076cc0b2580a-0
00:01:53.080 --> 00:01:57.360
And lastly the regulatory authority
references the Common Rule.

803c71ba-1f7b-4607-885e-525750b79cb0-0
00:01:59.800 --> 00:02:02.280
Below the summary view is the workflow
map.

19b0f2d7-5633-41ef-90d1-bebe01b92a3f-0
00:02:03.000 --> 00:02:07.766
This shows the steps of the IRB process
from pre submission all the way through

19b0f2d7-5633-41ef-90d1-bebe01b92a3f-1
00:02:07.766 --> 00:02:08.720
Review Complete.

0340f7fc-2a46-4351-9218-73f8b4050003-0
00:02:09.840 --> 00:02:14.074
The highlighted step in orange shows you
exactly where your submission currently

0340f7fc-2a46-4351-9218-73f8b4050003-1
00:02:14.074 --> 00:02:14.440
stands.

2b914e2c-9b76-49d1-a99a-d83571e6b27c-0
00:02:16.720 --> 00:02:18.840
Now let's explore the resource tabs.

fe3cb2c8-9083-43b0-aa3b-2adbaa79c367-0
00:02:20.200 --> 00:02:23.816
The History tab logs every activity
that's occurred,

fe3cb2c8-9083-43b0-aa3b-2adbaa79c367-1
00:02:23.816 --> 00:02:26.000
with the most recent at the top.

3f44b890-d270-434a-b8fd-52cc22690d4d-0
00:02:27.200 --> 00:02:29.720
Click on any activity name for more
details,

3f44b890-d270-434a-b8fd-52cc22690d4d-1
00:02:29.720 --> 00:02:32.520
and you can use the filter to narrow your
search.

f800a810-d575-4abc-84e1-8e876423d32c-0
00:02:34.320 --> 00:02:38.960
The Funding tab reports on funding
sources and related grant information.

6d958003-b5e7-4d88-b614-58ffaf9e8da1-0
00:02:40.760 --> 00:02:44.040
The Contacts displays the Principal
Investigator,

6d958003-b5e7-4d88-b614-58ffaf9e8da1-1
00:02:44.040 --> 00:02:46.600
the study team and any guest reviewers.

e28e2842-1e9c-41ed-b8dc-c180f068c868-0
00:02:48.600 --> 00:02:51.560
The COI tab shows any conflicts of
interest.

1b7d9f3d-ab4e-49a1-a0c6-1dd0af2a3ad6-0
00:02:54.360 --> 00:02:58.079
The Documents tab gives you access to all
submission documents,

1b7d9f3d-ab4e-49a1-a0c6-1dd0af2a3ad6-1
00:02:58.079 --> 00:03:00.520
including version history when applicable.

67ef26c6-180e-4069-9f73-be65e035e652-0
00:03:02.400 --> 00:03:07.049
The Follow on Submissions tab only
appears on active studies and shows all

67ef26c6-180e-4069-9f73-be65e035e652-1
00:03:07.049 --> 00:03:11.016
associated modifications,
continuing reviews and reportable new

67ef26c6-180e-4069-9f73-be65e035e652-2
00:03:11.016 --> 00:03:11.760
information.

e01c9bed-543d-401f-9c89-541f207b0d64-0
00:03:13.800 --> 00:03:15.760
The Reviews tab is role dependent.

8d6dd07d-0b36-4dcd-a014-477402c1e81c-0
00:03:16.280 --> 00:03:18.840
Researchers will only see ancillary
reviews.

e9ab5b03-b9ce-44b9-889c-ad21c33bdc29-0
00:03:19.200 --> 00:03:22.364
IRB staff and committee members,
on the other hand,

e9ab5b03-b9ce-44b9-889c-ad21c33bdc29-1
00:03:22.364 --> 00:03:26.320
will see the full picture,
including the most recent pre review,

e9ab5b03-b9ce-44b9-889c-ad21c33bdc29-2
00:03:26.320 --> 00:03:30.520
committee reviews, ancillary reviews,
and committee member comments.

86305b01-e308-4b62-82c3-9d97eebe82b7-0
00:03:32.320 --> 00:03:37.944
The Snapshots tab contains HTML documents
that capture the review process at a

86305b01-e308-4b62-82c3-9d97eebe82b7-1
00:03:37.944 --> 00:03:39.440
single point in time.

ea3e1ef2-f2d9-4c43-95b5-aedaa557ed3f-0
00:03:40.560 --> 00:03:45.562
Snapshots are generated automatically,
typically when the Pi submits a study,

ea3e1ef2-f2d9-4c43-95b5-aedaa557ed3f-1
00:03:45.562 --> 00:03:49.281
a clarification,
or a response to required modifications,

ea3e1ef2-f2d9-4c43-95b5-aedaa557ed3f-2
00:03:49.281 --> 00:03:52.360
or when the IRB sends the determination
letter.

f90e8c60-b5f3-4317-a277-1e7c57c89c90-0
00:03:53.880 --> 00:03:55.600
Lastly, we have the Training section.

25d71bfe-7db0-4a21-87ec-0362fe8f313a-0
00:03:56.440 --> 00:04:00.280
Any necessary training courses the Pi
needs to take will appear here.

a284d1eb-92fe-4bb6-8a08-eccedb756f9a-0
00:04:02.960 --> 00:04:06.044
Last but not least,
on the left you'll see all available

a284d1eb-92fe-4bb6-8a08-eccedb756f9a-1
00:04:06.044 --> 00:04:08.480
Activity and Next Step buttons on this
side.

6af6d92e-a819-4c62-addb-badb120a86d2-0
00:04:09.720 --> 00:04:13.725
It's important to note that the buttons
and activities you see here will change

6af6d92e-a819-4c62-addb-badb120a86d2-1
00:04:13.725 --> 00:04:16.480
based on your role and the current state
of the study.

2854175e-9116-4caa-91c8-4bba36d77b16-0
00:04:17.640 --> 00:04:20.160
And that concludes your tour of the study
workspace.

464b5b7b-2177-460e-92a8-b8c9f75a0752-0
00:04:20.480 --> 00:04:23.080
For more information,
please visit the training site.

9a97c7bd-d20f-4f65-8945-17392cf7c5eb-0
00:04:23.360 --> 00:04:24.280
Thanks for watching.