CLARA generally allows only one form at a time to be under IRB review. This restriction means, for example, you can’t submit a modification on a study until your new submission is approved, or, importantly, you can’t submit a continuing review (CR) form while a modification is outstanding. The only exceptions are that CLARA will allow you to create a reportable new information form or a closure form at any time.
This limit on the number and type of forms that can be active was intentional and is based on our experience in ARIA, where we’d often have multiple submissions on a single study pending simultaneously. Sometimes these submissions would contradict each other or would not be approved in the correct order, and we wanted to prevent this kind of problem from happening in CLARA.
Please keep this restriction in mind when planning your CR submission. If any forms are pending review when you try to submit a CR, you will not be able to access the CR form. You’ll see only the reportable new information and closure forms when you try to create a new form. You will have to either cancel whatever form is still pending and submit the CR (recommended if your CR expiration date is looming) or wait until the pending form is approved by the IRB before submitting your CR form. We also no longer allow study modifications to submitted with the CR form (another change from ARIA); they have to be sent to the IRB on a modification form.