WEBVTT

74b2d8a2-720a-4f13-a2ad-e8d1455296bd-0
00:00:00.520 --> 00:00:03.636
In this video,
I'm going to show you how to respond when

74b2d8a2-720a-4f13-a2ad-e8d1455296bd-1
00:00:03.636 --> 00:00:06.480
the IRB issues one of the following
determinations.

09e49e39-6d53-4b35-b5fd-118e0f178d0f-0
00:00:06.960 --> 00:00:12.320
Modifications required to secure approved,
Modifications required to secure not

09e49e39-6d53-4b35-b5fd-118e0f178d0f-1
00:00:12.320 --> 00:00:17.680
human research and modifications required
to secure human research not engaged.

91128191-4354-4844-941f-91b3f08c1ec3-0
00:00:18.640 --> 00:00:23.247
These determinations mean the IRB has
reviewed your submission and needs you to

91128191-4354-4844-941f-91b3f08c1ec3-1
00:00:23.247 --> 00:00:26.760
make specific changes before a final
decision can be issued.

521f3aed-d5d7-44de-81ae-ec7ad1932778-0
00:00:27.560 --> 00:00:29.520
Let's walk through the process step by
step.

0b9105f8-75e9-4c62-b347-847fb016f8b5-0
00:00:30.560 --> 00:00:33.439
For this demonstration,
I'm logged in as the Principal

0b9105f8-75e9-4c62-b347-847fb016f8b5-1
00:00:33.439 --> 00:00:34.120
Investigator.

d2c40098-b22c-4f34-8bff-2ddae02884e6-0
00:00:34.720 --> 00:00:39.196
The Pi has received a determination
letter indicating that a modification is

d2c40098-b22c-4f34-8bff-2ddae02884e6-1
00:00:39.196 --> 00:00:39.720
required.

a2488b42-136c-4376-a23a-bf3632bf511f-0
00:00:40.240 --> 00:00:44.080
You can find this letter in your study
workspace under the History section.

76159f0a-46a8-4b25-95b8-9757ef168274-0
00:00:46.200 --> 00:00:48.760
The required modifications will be listed
here.

20d57ce0-2df6-4605-97cd-4efdd72b97b1-0
00:00:50.280 --> 00:00:54.580
To respond to the required modification,
first write a letter responding to the

20d57ce0-2df6-4605-97cd-4efdd72b97b1-1
00:00:54.580 --> 00:00:57.000
requested change by clicking Prepare
Letter.

d9b1aeea-b7f2-4a84-a5ad-0577d587b736-0
00:01:00.120 --> 00:01:02.729
If you would like to use a prepared
template,

d9b1aeea-b7f2-4a84-a5ad-0577d587b736-1
00:01:02.729 --> 00:01:06.360
select the template from the drop down
list and click Generate.

40e081b8-4bca-4595-bca4-25a1c9442eaf-0
00:01:09.760 --> 00:01:11.040
Or you can click Upload.

5cd4df87-c0e7-4762-afac-ce7241308454-0
00:01:11.040 --> 00:01:13.560
To upload a draft, click OK.

a264d517-066c-420e-9cd4-40be948440d6-0
00:01:16.880 --> 00:01:19.929
In order to respond to the required
modification,

a264d517-066c-420e-9cd4-40be948440d6-1
00:01:19.929 --> 00:01:23.040
you'll need to complete the following
tasks first.

e889fd68-6455-4b51-8d84-ca670816453d-0
00:01:23.040 --> 00:01:25.742
If needed,
revise the documents attached to the

e889fd68-6455-4b51-8d84-ca670816453d-1
00:01:25.742 --> 00:01:26.080
study.

e27da7f4-44e4-4e2f-bddc-dd075489b645-0
00:01:26.680 --> 00:01:31.585
Be sure to use the Track Changes feature
in Microsoft Word so the IRB can clearly

e27da7f4-44e4-4e2f-bddc-dd075489b645-1
00:01:31.585 --> 00:01:33.560
see what modifications were made.

98ea0d4a-04d5-4fd3-ad49-f62b011d63d7-0
00:01:34.360 --> 00:01:38.684
This is an important step because it
allows reviewers to quickly identify what

98ea0d4a-04d5-4fd3-ad49-f62b011d63d7-1
00:01:38.684 --> 00:01:41.640
changed without having to compare
documents manually.

45dd2c54-99f3-4c7b-908e-2fcfb7edb93c-0
00:01:42.840 --> 00:01:45.715
Second,
upload the revised document back into the

45dd2c54-99f3-4c7b-908e-2fcfb7edb93c-1
00:01:45.715 --> 00:01:47.440
system by clicking Edit Study.

03b5451b-84cc-4d08-9c32-f20424fd2845-0
00:01:51.040 --> 00:01:55.419
Navigate to the appropriate section and
click Update next to the document you're

03b5451b-84cc-4d08-9c32-f20424fd2845-1
00:01:55.419 --> 00:01:55.960
replacing.

c84151a9-acba-48d1-9772-36993ef770ae-0
00:01:58.920 --> 00:02:02.040
Once the upload is complete, click Save,
then Exit.

20486afc-af36-4d08-a9b2-3537430ccbab-0
00:02:09.850 --> 00:02:12.330
Now it's time to submit everything to the
IRB.

95630660-0ca1-418a-b01f-11daee3ecf23-0
00:02:12.930 --> 00:02:15.690
Click Submit Response from the Study
workspace.

1e94698b-ede2-42e9-a9c9-c9cfae806475-0
00:02:20.170 --> 00:02:22.930
In the response window,
you'll see two areas,

1e94698b-ede2-42e9-a9c9-c9cfae806475-1
00:02:22.930 --> 00:02:25.810
the Notes section and the supporting
documents.

60e27cb3-86e9-461a-bcd2-9d7043bae422-0
00:02:26.770 --> 00:02:30.533
In the Notes section,
write any additional comments or context

60e27cb3-86e9-461a-bcd2-9d7043bae422-1
00:02:30.533 --> 00:02:31.250
for the IRB.

c6753ff2-7373-42ab-87e4-48b5e351e6bf-0
00:02:37.560 --> 00:02:41.658
In the Supporting Documents section,
if you've written a response letter,

c6753ff2-7373-42ab-87e4-48b5e351e6bf-1
00:02:41.658 --> 00:02:42.600
attach this here.

d5c0a096-061b-43d3-8428-f4550fcbdd32-0
00:02:44.640 --> 00:02:48.704
Once everything looks good,
click OK to submit the modification back

d5c0a096-061b-43d3-8428-f4550fcbdd32-1
00:02:48.704 --> 00:02:50.000
to the IRB for review.

c7adefb8-5c3e-4503-9386-04a7b3b61dfa-0
00:02:56.680 --> 00:03:00.634
Now you can see that the study has
updated to the modification submitted

c7adefb8-5c3e-4503-9386-04a7b3b61dfa-1
00:03:00.634 --> 00:03:00.960
state.

044f9617-7429-453b-b47d-101c8f15eebe-0
00:03:05.160 --> 00:03:08.904
After you've submitted your response,
you can verify the changes you made using

044f9617-7429-453b-b47d-101c8f15eebe-1
00:03:08.904 --> 00:03:09.840
the Compare feature.

b0b36f0b-213c-467f-b0c2-f98eb7480699-0
00:03:10.480 --> 00:03:15.520
Click view Study and click Compare.

12775321-b6af-4273-ab3c-45dc449a5f22-0
00:03:18.080 --> 00:03:21.066
Since I didn't make any changes whenever
I updated the study,

12775321-b6af-4273-ab3c-45dc449a5f22-1
00:03:21.066 --> 00:03:22.800
it doesn't show anything right here.

fbdce702-59ac-4685-a8dd-10f114893473-0
00:03:23.720 --> 00:03:28.960
Click Exit and that's it.

305d88a8-9b57-4869-bb56-3644f445f490-0
00:03:29.560 --> 00:03:31.920
For more information,
check out the training site.

9abb826a-cc62-4dfe-9cd3-9a1233902740-0
00:03:32.400 --> 00:03:33.280
Thanks for watching.