The term Common Data Elements (CDEs) was introduced by the NIH/NCATS Global Rare Diseases Patient Registry Data Repository (GRDR) program to define those database fields (elements) which could be used in any rare disease registry. CDEs are necessary to ensure that data are defined in the same way, use the same standards, and use the same terminologies.
The use of CDEs facilitates the standardization of data entry and allows for harmonization, sharing and exchange of information across registries and diseases, as well as various analyses and studies. CDEs capture information with sufficient details that are needed for most clinical research on rare diseases.
Based on the comparative analysis among existing lists of CDEs, we developed a minimum dataset for patient data entry to be used in the RD-Connect framework.
Improving the cooperation among registries at European level will require continuous harmonization and alignment of the RD-Connect CDEs with the Minimal Data Elements developed for the CDEs of the European initiative EUCERD-Joint Action.