When submitting studies to CLARA, please keep in mind that the IRB does NOT routinely need to see case report forms (CRFs). If they are submitted with a study, the IRB will not review them closely and will, in fact, try to remember to ask you to delete them from the submission before we approve the study. We know that very often, particularly on industry-sponsored studies, the CRFs will be electronic forms that are not easily uploadable. And regardless of the CRFs’ format, their content is outside the scope of the IRB’s review. (See IRB Policy 7.1 for the elements the IRB is to focus on when it approves research.) Also, if you send the IRB your CRF with your new submission, and then those CRFs show up as “approved” on your approval letter, you risk getting a later audit finding if you don’t submit any later changes to the CRF (even though the IRB won’t look at a CRF closely, and doesn’t need to approve the CRF in the first place). So please don’t routinely submit CRFs with new submissions.
Two possible exceptions:
If for some reason the reviewers feel they need to see a CRF at baseline, we’ll ask you for them.
If your protocol does not spell out all of the data elements you are going to record, but you have a data collection tool that does list everything, feel free to include that with your submission to support your protocol.