The Model Registry Common Data Elements (CDEs) was developed by an external committee established by the Office of Rare Diseases Research (ORDR) Vocabulary and CDEs Steering Committee and was designed to capture the information that is needed for all or most clinical research on rare diseases at a minimum level. These CDEs are not meant to satisfy all the needs of rare disease-specific registries. A specific registry could choose to use a more precise level of detail for a data element, but if that is done, it should map to the original common data element. Disease related and disease specific CDEs will be developed as part of the GRDR CDEs which will collect only de-identified information.

The recommended degree of requirment for each CDE is indicated in the last row of the CDEs document. Required CDEs are elements that should be used in any registry. Optional CDEs are elements that can be added to the required elements based on the needs of the specific registry.

To the list of CDEs, we provided additional information such as definitions of each element and the response catagories (how the answer should be provided), the source for each element, and the reference/link. This Model Registry CDEs list is a mix of required and optional elements based on different categories:

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

As the GRDR CDEs (collecting only de-identified data) will continue to expand, desease related and desease specific CDSe will be added based on a recommendation by external od expert committee.

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