Clinical Research Operations

Frequently Asked Questions: Study Closure Form

• 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?

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

These pages will continue to be updated as more information becomes available.

Note: If you have a submission procedure question that isn’t answered within these pages, please contact: nciprotocolsupportoffice@mail.nih.gov