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Global Rare Diseases Patient Registry Data Repository

Common Data Elements (CDEs)

A young girl with WAGR syndrome.CDEs enable information to be collected and presented in consistent formats to ensure data from different sources are defined in the same way using the same standards and vocabulary. A CDE consists of both a precisely defined question and a specified format or set of permissible responses.  

Each CDE represents a variable that can be collected and analyzed in projects and registries within a particular analytic or clinical domain. Researchers can combine sets of CDEs consisting of individual question-answer pairs into more complex questionnaires, survey instruments and case report forms for use in collecting data for research, patient registries and surveillance studies.

GRDR® program staff have developed a model registry of CDEs (Excel - 49KB) for entry of patient data into any rare disease registry. These CDEs are not intended to address all the needs of a specific rare disease registry; rather, the CDEs are designed to capture information at a minimum level of detail that is needed for all or most rare diseases studies. This model can be modified and tailored according to the specific needs of the registry. The GRDR program CDEs include a subset of CDEs that do not include personal information that could identify the patient.

The GRDR CDEs are organized into 10 categories that include required and optional elements:

  • Current contact information
  • Sociodemographic information
  • Diagnosis
  • Family history
  • Birth and reproductive history
  • Anthropometric (body measurement) information
  • Patient-reported outcomes
  • Medications, devices and health services
  • Clinical research participation and biospecimen donation
  • Communication and preferences

The list of GRDR CDEs will continue to expand to include new CDEs and validated disease-specific elements for data entry by patients, clinicians, other health care professionals and researchers. All future recommended GRDR CDEs will be established in collaboration with NIH Institutes and Centers and other professional patient organizations involved in CDE development. Learn more about CDE initiatives within NIH and other federal agencies or explore NIH’s CDE collection.

Last updated: 08-07-2017
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