NIH/NCATS/GRDR® Common Data Elements: A leading force for standardized data collection
Open accessAbstract
The main goal of the NIH/NCATS GRDR® program is to serve as a central web-based global data repository to integrate de-identified patient clinical data from rare disease registries, and other data sources, in a standardized manner, to be available to researchers for conducting various biomedical studies, including clinical trials and to support analyses within and across diseases. The aim of the program is to advance research for many rare diseases. One of the first tasks toward achieving this goal was the development of a set of Common Data Elements (CDEs), which are controlled terminologies that represent collected data. A list of 75 CDEs was developed by a national committee and was validated and implemented during a period of 2 year proof of concept. Access to GRDR CDEs is freely available at: https://grdr.ncats.nih.gov/index.php?option=com_content&view=article&id=3&Itemid=5. The GRDR CDEs have been the cornerstone of the GRDR repository, as well as of several other national and international patient registries. The establishment of the GRDR program has elevated the issue of data standardization and interoperability for rare disease patient registries, to international attention, resulting in a global dialog and significant change in the mindset of registry developers, patient advocacy groups, and other national and international organizations.
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Rubinstein, Y., Groft, S. C., Bartek, R., Brown, K., Christensen, R., COLLIER, E. S., Farber, A., Farmer, J. M., Ferguson, J. H., Forrest, C. B., et al. (2010) · Contemporary Clinical Trials · doi:10.1016/j.cct.2010.06.007 · Cited by 111 · see citing works
Self-citationChoquet, R., Maaroufi, M., de Carrara, A., Messiaen, C., Luigi, E., & Landais, P. (2014) · Journal of the American Medical Informatics Association · doi:10.1136/amiajnl-2014-002794 · Cited by 91 · see citing works
The case for a global rare-diseases registry
Forrest, C. B., Bartek, R., Rubinstein, Y., & Groft, S. C. (2010) · The Lancet · doi:10.1016/s0140-6736(10)60680-0 · Cited by 78 · see citing works
Self-citationTaruscio, D., Mollo, E., Gainotti, S., de la Paz, M. P., Bianchi, F., & Vittozzi, L. (2014) · Archives of Public Health · doi:10.1186/2049-3258-72-35 · Cited by 60 · see citing works
Building a Common Pediatric Research Terminology for Accelerating Child Health Research
Kahn, M. G., Bailey, L. C., Forrest, C. B., Padula, M., & Hirschfeld, S. (2014) · PEDIATRICS · doi:10.1542/peds.2013-1504 · Cited by 41 · see citing works
Daneshvari, S., Youssof, S., & Kroth, P. J. (2013) · Europe PMC (PubMed Central) · Cited by 12 · see citing works
Soon, S.-S., Junior, G. L. L., Lim, H.-Y., Wong‐Rieger, D., Bahri, S., Hickinbotham, L., Jha, A., Ko, B., MacDonell, D., Pwu, J., et al. (2014) · Orphanet Journal of Rare Diseases · doi:10.1186/s13023-014-0137-1 · Cited by 5 · see citing works
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Research works printed but not linked: 2
- [4]Jenders RA McDonald C Rubinstein YR Groft S Applying Standards to Public Health: An Information Model for a Global Rare-Diseases Registry I 1819 American Medical Informatics Association symposium Proc. 2011
- [11]AHRQ Registries for Evaluating Patient Outcomes A User’s Guide: 3rd Edition Research Report - Final – Apr. 30, 2014
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Improving the value of clinical research through the use of Common Data Elements
Sheehan, J. R., Hirschfeld, S., Foster, E. D., Ghitza, U. E., Goetz, K., Karpinski, J., Lang, L., Moser, R. P., Odenkirchen, J. C., Reeves, D. M., et al. (2016) · Clinical Trials · doi:10.1177/1740774516653238 · Cited by 130 · see citing works
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Rubin, D. L., & Kahn, C. E. (2016) · Radiology · doi:10.1148/radiol.2016161553 · Cited by 97 · see citing works
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Rubinstein, Y., Robinson, P. N., Gahl, W. A., Avillach, P., Baynam, G. S., Cederroth, H., Goodwin, R. M., Groft, S. C., HANSSON, M. G., Harris, N. L., et al. (2020) · JAMIA Open · doi:10.1093/jamiaopen/ooaa030 · Cited by 58 · see citing works
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The Minimum Data Set for Rare Diseases: Systematic Review
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Jia, J., & Shi, T. (2017) · Science China Life Sciences · doi:10.1007/s11427-017-9099-3 · Cited by 33 · see citing works
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Derayeh, S., Kazemi, A., Rabiei, R., Hosseini, A., & Moghaddasi, H. (2018) · Intractable & Rare Diseases Research · doi:10.5582/irdr.2018.01065 · Cited by 23 · see citing works
Tarride, J., Okoh, A. I., Aryal, K., Prada, C., Milinkovic, D., Keepanasseril, A., & Iorio, A. (2024) · Orphanet Journal of Rare Diseases · doi:10.1186/s13023-024-03193-y · Cited by 18 · see citing works
Barra, M. E., Zink, E. K., Bleck, T. P., Cáceres, E. L., Farrokh, S., Foreman, B. P., Cediel, E. G., Hemphill, J. C., Nagayama, M., Olson, D. M., et al. (2023) · Neurocritical Care · doi:10.1007/s12028-023-01803-4 · Cited by 18 · see citing works
Kentgen, M., Varghese, J., Samol, A., Waltenberger, J. L., & Dugas, M. (2019) · JMIR Medical Informatics · doi:10.2196/14107 · Cited by 16 · see citing works
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Navale, V., & McAuliffe, M. (2018) · F1000Research · doi:10.12688/f1000research.16015.1 · Cited by 14 · see citing works
Common data elements for arthrogryposis multiplex congenita: An international framework
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Wilson, Y. A., Smithers‐Sheedy, H., Ostojic, K., Waight, E., Kruer, M. C., Fahey, M. C., ICPGC Phenotype Working Group*, Baynam, G. S., Gécz, J., Badawi, N. A., et al. (2022) · Developmental Medicine & Child Neurology · doi:10.1111/dmcn.15245 · Cited by 12 · see citing works
Automated Population of an i2b2 Clinical Data Warehouse using FHIR.
Solbrig, H. R., Hong, N., Murphy, S. N., & Jiang, G. (2018) · Europe PMC (PubMed Central) · Cited by 12 · see citing works
Development of an informatics system for accelerating biomedical research.
Navale, V., Ji, M., Vovk, O., Misquitta, L., Gebremichael, T., Garcia, A., Fann, Y. C., & McAuliffe, M. (2019) · F1000Research · doi:10.12688/f1000research.19161.2 · Cited by 11 · see citing works
Roy, B., Peck, A., Evangelista, T., Pfeffer, G., Wang, L. L., Díaz‐Manera, J., Korb, M. K., Wicklund, M., Milone, M., Freimer, M. L., et al. (2023) · Annals of Clinical and Translational Neurology · doi:10.1002/acn3.51760 · Cited by 10 · see citing works
Shankar, R. K., Carl, A., Law, J. R., Bamba, V., Brickman, W. J., Prakash, S. K., Dowlut‐McElroy, T., Howell, S., Gutmark‐Little, I., Klein, K. O., et al. (2023) · American Journal of Medical Genetics Part A · doi:10.1002/ajmg.a.63441 · Cited by 9 · see citing works
Martín, E. L., Thompson, R., Gainotti, S., Wang, C. M., Rubinstein, Y., Taruscio, D., Monaco, L., Lochmüller, H., Alonso, V., & de la Paz, M. P. (2016) · Expert Opinion on Orphan Drugs · doi:10.1080/21678707.2016.1188002 · Cited by 9 · see citing works
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Chong, C. D., Ashina, S., Kamins, J., Scher, I., Gentile, C. P., Finkel, A. G., Oshinsky, M. L., & Schwedt, T. J. (2023) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14653 · Cited by 6 · see citing works
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Developing Multicenter Registries to Advance Quality Science
Schleelein, L. E., Harris, K. A., & Elliott, E. M. (2018) · Anesthesiology Clinics · doi:10.1016/j.anclin.2017.10.002 · Cited by 5 · see citing works
NAMSE-Register-Strategiegruppe, Storf, H., Stausberg, J., Kindle, G. R., Quadder, B., Schlangen, M., Walter, M. C., Ückert, F., & Wagner, T. O. F. (2020) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · doi:10.1007/s00103-020-03151-6 · Cited by 5 · see citing works
Data harmonization framework for neonatal hypoxic-ischemic encephalopathy studies
Hsiao, C., Foster, A. N., McDonald, S. A., Vyas, R., Ashraf, A., Bao, R., Tran, L., Kesri, A., Darzidehkalani, E., Soldatelli, M. D., et al. (2025) · JAMIA Open · doi:10.1093/jamiaopen/ooaf086 · Cited by 4 · see citing works
Rafid, F. A., Benissan, E., Murr, L., Ermakov, I., Oikonomou, K., & Zhang, P. (2022) · IEEE International Conference on Blockchain, Smart Healthcare and Emerging Technologies (SmartBlock4Health) · doi:10.1109/smartblock4health56071.2022.10034646 · Cited by 4 · see citing works
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Fiol, G. D., Orleans, B., Kuzmenko, T. V., Chipman, J., Greene, T., Martínez, A., Wirth, J., Meads, R., Kaphingst, K. A., Gibson, B., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-081455 · Cited by 3 · see citing works
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- Authors
- Rubinstein, Y. R., & McInnes, P.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- Rubinstein, Yaffa R.
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2015-05
- Volume
- 42
- Pages
- 78-80
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC4450118
- OpenAlex
- W2009470317
- Cited by
- 58
- References
- 7
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 8 · 2023: 7 · 2022: 3 · 2021: 4 · 2020: 6 · 2019: 5 · 2018: 6 · 2017: 7 · 2016: 3 · 2015: 1 · 2013: 1
- FWCI
- 15.24
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (Z99 TR999999)
- Topics
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Biomedical Text Mining and Ontologies
- Keywords
- common data elements, rare disease registry, data standardization, interoperability, de-identified patient data, controlled vocabulary, patient advocacy
- MeSH terms
- Data Collection, Humans, Databases, Factual, Rare Diseases, Biomedical Research, Common Data Elements
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