Hint No. 1 — When completing your study’s continuing review form, please remember NOT to include with the form any document amendments you’re hoping to get approved. The IRB no longer reviews amended documents with continuing reviews, and hasn’t done so since we switched from ARIA to CLARA. In some cases, the IRB may have continuing review contingencies that require you revise documents. If you get such a letter from the IRB, you can submit revised documents that address those contingencies in response. Any other changes should be submitted as a modification, either before you submit your continuing review, or after your continuing review is approved.
Hint No. 2 — If you are completing a continuing review form on a study whose IRB approval has expired, please go ahead and mention in the study summary whether any study activity has occurred since expiration. If it has, please also describe any activities in question. The IRB will need to know this information to review the continuing review submission, and including it up front may save you a contingency.