DataFax eCRF Design

Perhaps not everybody realizes that using Electronic Data Capture (EDC) as method for data collection in a DataFax study, might impose some new Options and Requirements regarding CRF Design. In the past, a DataFax Case Record Form (CRF) served a dual purpose. It was printed to create the paper forms to collect data and the same PDF File was used to create the Background images for the Data Entry Screens. As the paper Forms required Barcodes, the Data Entry Screens also had barcodes on top of each page. Another essential part of the CRF in a paper study were the boxes for each item. On the paper Form, they served the purpose of providing a location to enter the handwritten information, and on the Screens, they were essential as they indicated to the OCR where to look for the handwritten data. Both essential features of a paper collection study have become obsolete in an EDC study.

So an essential question at the start of a new EDC based DataFax Study is: “Is there any chance that (part of) the data collection will be paper based? And/or do we need to allow some sites to ‘fall back’ on paper collection of study information ?

If the Answer is no, then there is no reason to include barcodes on your eCRF (which will be used to create the Data Entry screens). They are only a rememberance to a ‘paper-based past’, serve no purpose and use valuable space on each Form.

And another issue to take into account is the impact boxes and related information might have on the Data Entry screens. Have a look at the field CRF No, in a paper based study, this was a pre-printed number. So you would need a square box around the pre-printed number. This box is partly visible on the Data Entry screen, nothing to do about that in a paper based. But in an EDC study, the box serves no purpose and can easily be deleted.

The same holds for the “Day   Month    Year”, they originate from additional text below the boxes for DD/MMM/YYYY. The boxes itself have been deleted, a new (much shorter) has replaced the original boxes, but the text is still there. Confusing as it is in the wrong location. Again, in an EDC study, there is no need to even have boxes on your eCRF.

For reasons like these, we (Thorin) have always created a separate PDF file to be used for the creation of the background images.

But what if you want to combine ‘paper sites’ with ‘EDC sites’, or collect some information by paper Forms and other information by EDC ? That’s something to be discussed in a next Blog, so stay tuned….Or click on CRF Design using Adobe Indesign, which will take you to the next Post.