Short Description 

Traditionally, clinical data was captured using paper case report forms (CRFs) and manually digitised afterwards. Nowadays data is digitally collected in Electronic Data Capture systems (EDCs) in electronic Case Report Forms (eCRFS). Many EDCs exist, such as OpenClinica / LibreClinica, Castor EDC and REDCap and the majority of the Dutch UMCs have a site license for such tools. EDCs offer a variety of functionality, such as data entry validation, import/export functionality and monitoring [hri].  

...

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]. 

Why is this step important 

This section should explain why this step is crucial 

Expertise requirements for this step 

This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.  

How to 

To design an eCRF, a number of things must be kept in mind: 

...

Depending on your project, data collection could take place in one or more EDCs.

Practical Examples from the Community 

This section should show the step applied in a real project. Links to demonstrator projects. 

Further reading & References 

[FAIRopoly] FAIRopoly https://www.ejprarediseases.org/fairopoly/ 

...

[iCRF] https://f1000research.com/articles/9-81  

Authors / Contributors 

Experts who contributed to this step and whom you can contact for further information