Guidelines for Submitting Clinical Research Information to an External IRB

myRESEARCH IRB Instructions to
Submit CR Information When
Using an External IRB
Click on Active study
 Click “report
continuing
review data”
and then
complete
questions in
pop up screen
Click ok when
finished
Click: CREATE
MODIFICATION
Click Modification and
then choose the
appropriate scope below,
then continue
Choose appropriate status
of study
Check if modification
requires subject notification.
Leave blank if N/A
Provide Summary of
modification – This acts as
cover memo
Then CONTINUE
EX:
Minor Amendment:
1. Change in personnel – addition of Jane Doe
OR
1. Continuing Review Submission
Update Funding if Applicable
Update and add personnel/locations if
applicable
*
These pages only pop up if study team option was
chosen on first page
Add updated site specific Consent Forms
Add updated site recruitment materials
Add “other” updated site specific Forms
i.e. redacted consent form and I/E checklist if
enrolled since last approval
Make note of any ancillary reviews
required for submission – this will be
managed on the next page
Click FINISH
Click 
blue
 study link to upload
current 
reviewing
 IRB documents
into the “study”
i.e. current approval letter, updated
protocol, updated 
master
documents (not site specific)
Click to EDIT STUDY
Include any changes to these
fields if applicable and then Add
Year to pre-fix of short title
Ex: “2019 CR: Advarra; Pfizer:
123456”
Continue..
Label and add updated version
of protocol then continue
Add renewal approval letter
Add or edit funding
information if applicable then
continue.
Only edit information if applicable (may need
to provide answer to new question #7 & #8
Then continue…
Update drug information or other study
specific fields if applicable, then continue to
next page and click 
FINISH
CLICK 
blue 
local site link to
return to site information
Manage Ancillary Reviews. Once
Chair signature obtained, PI must
“submit” the study
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Comprehensive instructions for submitting continuing review information when utilizing an external Institutional Review Board (IRB), including steps such as completing questions, selecting study status, updating funding, adding personnel, and uploading necessary documents.


Uploaded on Sep 12, 2024 | 0 Views


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  1. myRESEARCH IRB Instructions to Submit CR Information When Using an External IRB

  2. Click report continuing review data and then complete questions in pop up screen Click ok when finished

  3. Click Modification and then choose the appropriate scope below, then continue

  4. Choose appropriate status of study Check if modification requires subject notification. Leave blank if N/A EX: Minor Amendment: 1. Change in personnel addition of Jane Doe Provide Summary of modification This acts as cover memo Then CONTINUE OR 1. Continuing Review Submission

  5. Update Funding if Applicable

  6. Update and add personnel/locations if applicable *These pages only pop up if study team option was chosen on first page

  7. Add updated site specific Consent Forms Add updated site recruitment materials Add other updated site specific Forms i.e. redacted consent form and I/E checklist if enrolled since last approval

  8. Make note of any ancillary reviews required for submission this will be managed on the next page Click FINISH

  9. Click blue study link to upload current reviewing IRB documents into the study i.e. current approval letter, updated protocol, updated master documents (not site specific)

  10. Click to EDIT STUDY

  11. Include any changes to these fields if applicable and then Add Year to pre-fix of short title Ex: 2019 CR: Advarra; Pfizer: 123456 Continue..

  12. Label and add updated version of protocol then continue

  13. Add renewal approval letter

  14. Add or edit funding information if applicable then continue.

  15. Only edit information if applicable (may need to provide answer to new question #7 & #8 Then continue

  16. Update drug information or other study specific fields if applicable, then continue to next page and click FINISH

  17. CLICK blue local site link to return to site information

  18. Manage Ancillary Reviews. Once Chair signature obtained, PI must submit the study

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