We love hearing from our researchers; we really do. But here’s a tip that may save you a bit of extra work when submitting modifications, and contingency responses.
We often notice investigators send in separate letters to the IRB explaining something in their CLARA submission. Unless that letter includes information that’s not addressed elsewhere in CLARA, the letter is not required and you don’t have to submit it. Instead, if you’re responding to contingencies, you can comment under each individual contingency using the “comment” link in CLARA. In modifications, you can use the free-text response in the form to let us know anything you need to tell us regarding the modification.
New submissions might be the one place where you need to add information the CLARA new submission form doesn’t cover. For example, explaining that you need a quick approval to meet a funding deadline, and that you won’t begin the study until after funding is worked out and any noted deficiencies are handled via a later modification, can be addressed in a separate letter. But otherwise, you may be able to save yourself some time by using the CLARA system’s capabilities to relay information to the IRB, rather than drafting and submitting a separate letter.