PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already...
Transcript of PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already...
![Page 1: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/1.jpg)
PRESENTATION TITLE
Incident NotificationCayuse IRB
Office of Research and Sponsored Projects
Updated 12/2018
![Page 2: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/2.jpg)
How to use this tutorial
• This tutorial is for researchers (PIs) who already have an
approved IRB protocol and need to submit an Incident
Report.
![Page 4: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/4.jpg)
Click to access the study you want to Close.
![Page 5: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/5.jpg)
You’ll be taken to this page. Click on the blue button for “+New Submission”.
![Page 6: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/6.jpg)
Office of Research Compliance v2-2017
Select Incident.
Renewal = extending the study for up to a year, before the approved protocol expires.
Modification = submitting a change or amendment to the protocol
Incident = reporting an adverse eventClosure = you are finished collecting data for the
study
![Page 7: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/7.jpg)
You’re taken to this page. Click on “Edit” to provide a final progress report to close out the study.
![Page 8: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/8.jpg)
Fill out the form.
![Page 9: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/9.jpg)
When you have completed the Unanticipated Problem/Adverse Event Reporting form, click on “Complete Submission”.
![Page 10: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/10.jpg)
Click on “CONFIRM”.
![Page 11: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/11.jpg)
You will then be redirected to the Submission Details page. You will need to “CERTIFY” in order to finalize the submission.Certification says you knowingly mean to take this action (to renew, amend/modify, or close).
![Page 12: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/12.jpg)
After you have clicked CERITY under the Submission Details page, review the PI Certification Statement. After you read the statement click “CONFIRM”.
![Page 13: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/13.jpg)
After you have certified and confirmed your submission, you will notice your study is “Under Pre-Review” which means it’s with the IRB office to officially begin the review process.
You and any co-PIs should receive an email confirmation of the action and submission type you’ve just submitted.
![Page 14: PRESENTATION TITLE...How to use this tutorial •This tutorial is for researchers (PIs) who already have an approved IRB protocol and need to submit an Incident Report. Office of Research](https://reader033.fdocuments.in/reader033/viewer/2022050601/5fa833e62dac6158887f7698/html5/thumbnails/14.jpg)
• If you have any issues or questions, please contact the IRB Office: [email protected] or (657) 278-7719.
• As this is a new IRB system, if you find any issues (typos, unclear questions, etc.) please let us know!