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Altering an Approved Application

How do I alter an approved study?

Investigators are required to submit an Amendment Request in iMedRIS for any modifications they wish to make to the study after initial approval has been given by the IRB. The amendment must be approved prior to implementing modifications to the study procedure.

Adding or Removing Personnel

If you are only adding or removing personnel from UTK then you can submit a Personnel Change Request in iMedRIS. This form cannot be used to make any other changes to the application. Please see the guidance below for how to complete this change in iMedRIS.

Altering the application or Supplemental Documents

If you are making any changes to study procedures or non-UTK personnel an amendment must be submitted in iMedRIS. Please see guidance below on how to complete this form.

Amendment Request (Form 2)

If you have questions about the timeline of review please visit the Review Process page.