Page Flow in a DataFax EDC study

The order of Forms in the Patient Binder in iDataFax does not always coincide with the actual order of Forms or CRF pages. While this might not be a big issue in a Paper based trial, it becomes more of an issue when your study is pure EDC based. Especially in an EDC study, you want to guide the Investigator as much as possible by taking him/her in the proper order along each relevant Form for a Visit.
The record (CRF page or Form) order in the Patient Binder in iDataFax gets dictates by a simple rule. First it takes the Pages (read Plates) defined as ‘Required’ in the Visit Map (for each Visit). And then it adds the Optional pages for that visit. So unless your Optional pages are always at the end of the stack of Pages/Forms for each visit, you will have a problem.
This problem is further enhanced if you have additional pages which are triggered by certain Events. That is, any form triggered by one of the Conditional Maps will not be initially part of the Patient Binder in iDataFax (unless off course, it was defined in your Visit Map). Let’s take an example, if you have a Pregnancy Form which is triggered by the Edit Check function ‘dftrigger’ in case of a Female patient, what will happen is the following. The dftrigger functionality will the Pregnancy Form at the end of Patient Binder for that visit. The Pregnancy Form will be listed as ‘Diamond’, meaning ‘Unplanned Form’ (unless it was predefined as ‘Optional’ in the Visit map). And if dftrigger was defined that way, upon Plate Exit of the Demographics Form, you will be taken to the Pregnancy Form. Which is great, however, as the Pregnancy Form was the last Form of this Visit, iDataFax will think you are done with this visit.
So in order to get this work, you will need to keep track of the proper order of Forms and use dftrigger to guide you from one Form to the other Form.

About Sjouke

Sjouke is Managing Director of Thorin B.V. Since the early 90's, Thorin is the European distributor of the DataFax system. At Thorin, Sjouke is involved in all aspects of setting up DataFax studies, from hardware implementation, CRF Design to Study Setup & Edit Check programming. Sjouke has his background in Clinical Resarch and has worked in large research institutes before starting Thorin.
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