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New questions on CLARA new submission form

You may notice some new questions on the new submission form in CLARA. We’ve added some questions related to the use of external IRBs. If your study will undergo its primary review by an outside IRB, click “yes” to the “are you requesting use of an external IRB” query. The next question will ask for more details about which IRB will do the outside review.

Some examples of studies sent to outside IRBs include cancer studies now reviewed by the National Cancer Institute’s IRB, or industry sponsored-studies where the sponsor is using an outside IRB for the entire study.

If you have a new submission form in process, you may get an error message when you try to submit it if it was initiated before these new questions were added. If you do, fixing the problem is easy — you’ll just need to go back and answer the outside IRB-related questions to be able to submit the form.