Global Rare Diseases Patient Registry and Data Repository (GRDR) Goal:

The main goals are; to develop a set of Common Data Elements (CDEs) to facilitate data collection into the GRDR in a standardized and meaningful manner; to assist organizations with no patient registry to establish their own registry and be able to contribute their data into the GRDR or other databases; to facilitate harmonization between the many organizations collection patients information.The Office of Rare Diseases Research (ORDR), within the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), has developed a Model Registry CDEs (ORDR CDEs), for patient data entry to be used in any rare disease registry, which includes a set of CDEs (GRDR CDEs) to collect only de-identified information into the GRDR data repository. This model CDEs list has been developed by an external committee, established by the ORDR, and was modified by the GRDR team to address the needs of diverse diseases with unique requirements.

The list of the CDEs is divided into ten different categories, for example, Current contact information, Socio-demographic information, Diagnosis, and Family history.

Purpose

CDEs are necessary to ensure that data are defined in the same way, using the same standards, and the same vocabularies. Use of CDEs facilitates the standardization of data entry and allows for harmonization, sharing and exchange of information across registries and diseases and facilitates analyses and studies within a specific disease and across multiple diseases.

The GRDR will collect only de-identified information and therefore will not include any CDE associated with identifiable information. GRDR CDEs will continue to expand to include disease related and disease specific CDEs for patient data entry and for data entry/reporting by clinicians, other health care professionals, and researchers, which will be developed and approved by a committee of experts. All future recommended GRDR CDEs will be established in collaboration with the various NIH institutes and centers and other professional patient organizations which already developed related CDEs or are in the process of developing them.

The ORDR Registry Model CDEs is not intended to address all the needs of a specific rare disease registry. These CDEs are designed to capture the information at a minimum level of detail that is needed for all or most rare diseases. A specific registry could choose to use a more precise level of detailed information for a data element, in that case registries should use the CDE items "as is", and pair them if needed with more detailed questions to get information about a topic. More information about CDEs initiatives within the NIH and other federal agengies are available at :http://cde.nih.gov

For additional information or comments please e-mail Yaffa Rubinstein at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it