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The eCRF was designed to collect data for the CDEs (described in step 2) in the Castor EDC system [5]. Several dependencies, e.g. only show ‘Date of death’ when the patient is deceased, and validations, e.g. validate whether the entered Online Mendelian Inheritance in Man (OMIM) genetic disorder code follows the OMIM standard, were included in order to collect high-quality data (the eCRF questions can be found in [6]). To this end, we mostly worked with closed questions and/or drop-down menus and prevented entering free text as much as possible. An example from the eCRF is shown in Figure S1A. The eCRF template containing the CDEs and the ontologies to annotate them (see step 5) was described in a codebook. This codebook was made openly available in ART-DECOR, a platform from Nictiz, the Dutch competence centre for electronic exchange of health and care information [7], and can be directly implemented in the Castor EDC system or other EDC systems using the openly available iCRF Generator tool [8].
Working Group
Why is this step important
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