In a previous Blog-post, I have discussed the different requirements for (DataFax) CRF design for studies using paper forms compared to Electronic Data Capture (EDC). Especially when using DataFax as Clinical Data Management System (CDMS), it is equally possible to combine the two methods into one studie. Like a Patient Diary collected on paper forms, and the remainder by EDC. Or allow paper forms for sites which are lacking proper internet access. In these cases, you need to be able to be flexible in your CRF Design.
Although most DataFax sites are traditionally using Adobe Framemaker, for the plain reason that in the past, the tool to generate Barcodes was only available for Framemaker, nowadays Adobe Indesign would be a much better choice for CRF Design.
A major reason for this is that Adobe Indesign allows for Layers. Most DataFax users are using Masterpages, one for each Plate or Unique Page. So everything which changes over Visits needs to go on the Bodypage. And if you have a Vital Signs page where Height is only collected on the first visit, you need to create two Masterpages, one for the first visit (including Height) and another for all the other visits without Height. Not so much trouble until one of your reviewers request to update a Vital Signs item, then your CRF designer needs to figure out which Masterpages might be effected. If you have a single Layer containing the Vital Signs items, you update the Layer and that’s it. So from a QA point of view, there is a lot to say for using Layers.
In Adobe Indesign, this can all be done a lot easier by using Layers. So for the Vital Signs example. You just create one Vital Signs Masterpage. It has a Layer containing all the regular Vital Signs stuff. And for the first Visit, you just add another Layer with the Height. And along these same lines, using Indesign, you can more efficiently create even a basic Masterpage. In Framemaker, a Masterpage contains everything, in Indesign, your Masterpage might consist of several layers. Like a layer holding the Company logo, Study name, Study Barcode, etc. And another layer with the actual items. And the Items Layer, might even be two separate layers, one with the text of the individual questions and one with the boxes.
Same method can be used on the actual pages. While a Bodypage in Framemaker contains everything which cannot go on the Masterpage, in a properly designed Indesign CRF page, the page might contain multiple Layers. You could create separate Layers for each Visit, containing things like the Visit barcode, the Visit name, etc. So rather then copying/pasting this information from one page to another, you just turn on the proper layer.
So if you have a standard library of CRF pages, which are used for both paper and EDC, it will be a lot easier to adjust a new CRF for the data collection method. Purely EDC? Just turn off the layers containing the barcodes and the actual boxes. So unless all of your studies are 100% EDC, I think Indesign can help you in adjusting your CRF to have the proper content for the data collection method selected in a study.
You can find more information on our website regarding our CRF Design Training courses.
