In the past we had to attach a “termination query memo” from the central registration office to show the IRB that all subjects were off study. Do we still need to do that?
You should still request this memo from the CRO to confirm that all subjects have been removed from the protocol prior to submitting the study closure form. However, you do not have to submit this to the IRB; you can just keep it in your regulatory file.
FAQs for Routing in iRIS
FAQs for Study Application
FAQs for Continuing Review Submission Form
FAQs for Amendment Submission Form
FAQs for Planned and Cumulative Enrollment Forms
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