We’ve been using a simple repeating group on both our conmeds and adverse events CRFs (and any other “log” style CRFs), which I think is fairly standard practice.
However, we’ve noticed that there are some issues with using this approach. It makes using required fields problematic, out-of-range validation messages don’t display correctly if the field is on the last line, rules don’t fire correctly, there seem to be random problems with adding discrepancy notes.
But we do want the flexibility to add as many items as we need.
So we’ve been looking at a different approach. We’ve set up both types of log in a repeating event. The AE CRF itself only contains fields to record a single event (and no groups) but as it’s a repeating event, the CRF can be completed as many times as required.
We’ve used a similar approach to ConMeds except that we generally expect there to be more of these in a study so we’ve added as many sets of fields as there are entries on a single page of the paper log. Once again these are defined as separate fields rather than as a repeating group. So we might have NAMEOFDRUG1, NAMEOFDRUG2 etc. Hopefully that won’t be too messy to deal with at analysis. Then, if the subject has more than one page in the log, we enter a new Event and a fresh CRF is displayed. And so on.
To keep the look of the CRF neat, we use a “header” field for each Med and show/hide all the other fields. We cross reference each repeated CRF with a page number on the log.
We’re hoping this will overcome the problems we’ve had but as this is a new approach for us to a common set of CRFs, we thought we’d seek your thoughts.
Trial Database Manager
Tayside Medical Science Centre
Ninewells Hospital & Medical School
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