The short answer: You may not need to review it at all. Please check with the IRB office (Edith Paal prereviews almost all of the new submissions before you see them, so she’d be a good place to start) to see if you need to do anything with the CRF in the file.
The less short answer:
A case report form (CRF) is “a printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject,” per the Good Clinical Practice guidelines. They are most commonly used on FDA-regulated, industry sponsored trials, although they do turn up occasionally on other types of studies. They are completed by study staff and the research subjects typically don’t see them. Many, many years ago there was some debate as to whether the IRB needed to review or approved CRFs. After much discussion, it was decided that no, in general, the IRB does not need to routinely see CRFs, and CRFs should not be routinely included with new submissions. Many CRFs are electronic and not easily uploadable, or created by the sponsor and we’d have no input into their content anyway. In addition, review of CRFs is not covered by any of the criteria for approval that the IRB is supposed to consider in its reviews. (See some recent blog entries and IRB Policy 7.1 for a refresher on those criteria.) In addition, if the IRB lists the CRF on its list of approved documents on the study approval letter, the PI can get dinged in a later audit for failing to submit any future changes to the CRF for review/approval, even though the CRF is outside the IRB’s scope and the IRB probably didn’t need to review/approve it in the first place.
There are some exceptions — if, say, the prereviewer has requested the CRF be added to the submission for a particular reason, then it would need to be reviewed. However, if that’s the case, the prereviewer will document in CLARA the reason for including the CRF. Also, sometimes PIs submit data collection tools that include a long list of data elements they are going to collect as a supplement to their protocols, if the protocol doesn’t include a complete list of data items of interest. While these may not be true CRFs, they look a little bit like CRFs and should be reviewed to ensure that data being collected are appropriate for the study.
So if you see a CRF included in the documents of a study you’ve been assigned, and the reason for its being there is not clearly documented, please contact the IRB office for guidance. We can take a look and see if it does indeed need to be reviewed or if we should go ahead and draft a contingency requesting its removal from the file.