The Study Resumption form is now available in CLARA to reopen a closed study. The form will ask why the study was closed and the reason for reopening it, whether there have been any protocol changes since it was last open, and whether any study activities have occurred since the closure. You will also have the opportunity to upload any new documents. Once completed and signed, the Study Resumption form is submitted to the IRB office for review.
Note that, depending how long ago the study was closed, the first thing you may need to do after the study is reopened is to submit a continuing review form. The IRB office staffer reviewing the study resumption form will let you know if a continuing review is required.