IRB Duke Modification Approval Notice

APPROVAL NOTICE
MOD01364854
DATE:

7 Jul 2022

TO:

Jennifer Duke, Doctor of Philosophy

PROTOCOL:

RTI International - Monthly Monitoring Study (Pro00056113)

APPROVAL DATE:

30 Jun 2022
IRB APPROVED:

Documentation:



Protocol Version 4 (Not Dated)

Consent Forms:



ENDS Informed Consent Form (Advarra IRB Approved Version 30
Jun 2022)
LCCS Informed Consent Form (Advarra IRB Approved Version 30
Jun 2022)
ENDS Assent Form Ages 15-AOM (Advarra IRB Approved Version
30 Jun 2022)
LCCS Assent Form Ages 15-AOM (Advarra IRB Approved Version
30 Jun 2022)





The IRB has reviewed and approved the above referenced documentation.
The Consent Forms referenced above are now available on your Advarra CIRBI Platform workspace. The IRB
determined new subjects need to sign the above referenced Consent Forms.
If you wish to appeal the IRB’s determinations and/or imposed modifications, please submit supporting
documentation to address the IRB’s concerns by creating an Appeal Modification in CIRBI.
Please review the IRB Handbook located in the “Reference Materials” section of the Advarra CIRBI™ Platform
(www.cirbi.net). A copy of the most recent IRB roster is also available.
Thank you for continuing to use Advarra IRB to provide oversight for your research project.

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