Wikipedia

Sentinel Common Data Model

The Sentinel Common Data Model (CDM)[1] is a standardized data framework developed by the U.S. Food and Drug Administration (FDA) as part of the Sentinel System, a national electronic surveillance[2] system designed to monitor the safety of FDA-regulated medical products. The model provides a consistent structure for transforming healthcare data from different sources into a uniform format, enabling large-scale analyses of drug and medical device safety.

Overview

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The Sentinel CDM[3] is designed to facilitate active surveillance by allowing diverse healthcare data,[4] such as electronic health records (EHRs), administrative claims, and registry data, to be transformed into a common structure. This standardization reduces variability across data partners and ensures that analytical tools can be applied consistently across multiple datasets. The CDM supports observational research, safety studies, and public health monitoring.

Development

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The Sentinel CDM was created under the FDA’s Sentinel Initiative,[5] which was launched in 2008 in response to the Food and Drug Administration Amendments Act (FDAAA) of 2007. Its development has been guided by the need for scalability, transparency, and reproducibility in healthcare data analyses. The model is periodically updated to accommodate changes in coding systems,[6] healthcare practices, and regulatory requirements.

Structure

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The Sentinel CDM[7] consists of multiple standardized tables that capture different domains of healthcare data, including:

By using standardized terminologies[8][9] and coding systems such as ICD,[10][11] CPT,[12][13] and NDC,[14] the model ensures interoperability and comparability across data sources.

Applications

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The Sentinel CDM is primarily used for:

  • Medical product safety surveillance[15][16][17] to detect and assess potential safety signals for drugs, biologics, and devices.
  • Comparative effectiveness research[18] enabling evaluation of treatment outcomes[19][20] in real-world populations.
  • Public health monitoring[21] supporting rapid response to emerging health threats, such as vaccine safety evaluations.

See also

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References

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  1. ^ Research, Center for Drug Evaluation and (8 March 2024). "FDA's Sentinel Initiative". FDA.
  2. ^ "FRAMEWORK FOR FDA'S REAL-WORLD EVIDENCE PROGRAM". FDA.
  3. ^ Brown, Jeffrey S; Mendelsohn, Aaron B; Nam, Young Hee; Maro, Judith C; Cocoros, Noelle M; Rodriguez-Watson, Carla; Lockhart, Catherine M; Platt, Richard; Ball, Robert; Dal Pan, Gerald J; Toh, Sengwee (14 November 2022). "The US Food and Drug Administration Sentinel System: a national resource for a learning health system". Journal of the American Medical Informatics Association. 29 (12): 2191–2200. doi:10.1093/jamia/ocac153. PMC 9667154.
  4. ^ Platt, Richard; Brown, Jeffrey S.; Robb, Melissa; McClellan, Mark; Ball, Robert; Nguyen, Michael D.; Sherman, Rachel E. (29 November 2018). "The FDA Sentinel Initiative - An Evolving National Resource". The New England Journal of Medicine. 379 (22): 2091–2093. doi:10.1056/NEJMp1809643. ISSN 1533-4406.
  5. ^ Lavertu, Adam; Vora, Bianca; Giacomini, Kathleen M.; Altman, Russ; Rensi, Stefano (May 2021). "A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring". Clinical Pharmacology and Therapeutics. pp. 1197–1202. doi:10.1002/cpt.2172.
  6. ^ "Overview of Coding & Classification Systems | CMS". CMS.
  7. ^ "Common Data Model (CDM) Specification, Version 7.0" (PDF). PCORnet®.
  8. ^ "Health Data Standards and Terminologies: A Tutorial". National Library of Medicine.
  9. ^ "Terminology Standards | HIMSS". Healthcare Information and Management Systems Society, Inc. (HIMSS). 17 August 2017.
  10. ^ "WHO releases new International Classification of Diseases (ICD 11)". World Health Organization (WHO).
  11. ^ Reed, Geoffrey M.; First, Michael B.; Kogan, Cary S.; Hyman, Steven E.; Gureje, Oye; Gaebel, Wolfgang; Maj, Mario; Stein, Dan J.; Maercker, Andreas; Tyrer, Peter; Claudino, Angelica; Garralda, Elena; Salvador-Carulla, Luis; Ray, Rajat; Saunders, John B.; Dua, Tarun; Poznyak, Vladimir; Medina-Mora, María Elena; Pike, Kathleen M.; Ayuso-Mateos, José L.; Kanba, Shigenobu; Keeley, Jared W.; Khoury, Brigitte; Krasnov, Valery N.; Kulygina, Maya; Lovell, Anne M.; de Jesus Mari, Jair; Maruta, Toshimasa; Matsumoto, Chihiro; Rebello, Tahilia J.; Roberts, Michael C.; Robles, Rebeca; Sharan, Pratap; Zhao, Min; Jablensky, Assen; Udomratn, Pichet; Rahimi-Movaghar, Afarin; Rydelius, Per-Anders; Bährer-Kohler, Sabine; Watts, Ann D.; Saxena, Shekhar (February 2019). "Innovations and changes in the ICD-11 classification of mental, behavioural and neurodevelopmental disorders". World psychiatry: official journal of the World Psychiatric Association (WPA). pp. 3–19. doi:10.1002/wps.20611.
  12. ^ "Public reporting of surgical outcomes". Lancet (London, England). 2 April 2011. p. 1126. doi:10.1016/S0140-6736(11)60446-7.
  13. ^ Bodenreider, Oliver; Cornet, Ronald; Vreeman, Daniel J. (August 2018). "Recent Developments in Clinical Terminologies - SNOMED CT, LOINC, and RxNorm". Yearbook of Medical Informatics. pp. 129–139. doi:10.1055/s-0038-1667077.
  14. ^ Dugas, Martin. "Sentinel Common Data Model Pharmacy Dispensing - Portal of Medical Data Models (MDM-Portal)". Medical Data Models.
  15. ^ Cocoros, Noelle M.; Fuller, Candace C.; Adimadhyam, Sruthi; Ball, Robert; Brown, Jeffrey S.; Dal Pan, Gerald J.; Kluberg, Sheryl A.; Lo Re 3rd, Vincent; Maro, Judith C.; Nguyen, Michael; Orr, Robert; Paraoan, Dianne; Perlin, Jonathan; Poland, Russell E.; Driscoll, Meighan Rogers; Sands, Kenneth; Toh, Sengwee; Yih, W. Katherine; Platt, Richard; Group, And the FDA-Sentinel COVID-19 Working (2021). "A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System". Pharmacoepidemiology and Drug Safety. pp. 827–837. doi:10.1002/pds.5240. {{cite web}}: |last20= has generic name (help)CS1 maint: numeric names: authors list (link)
  16. ^ Brown, Jeffrey S.; Mendelsohn, Aaron B.; Nam, Young Hee; Maro, Judith C.; Cocoros, Noelle M.; Rodriguez-Watson, Carla; Lockhart, Catherine M.; Platt, Richard; Ball, Robert; Dal Pan, Gerald J.; Toh, Sengwee (14 November 2022). "The US Food and Drug Administration Sentinel System: a national resource for a learning health system". Journal of the American Medical Informatics Association: JAMIA. pp. 2191–2200. doi:10.1093/jamia/ocac153.
  17. ^ Huang, Kelly; Lin, Fang-Ju; Ou, Huang-Tz; Hsu, Chien-Ning; Huang, Ling-Ya; Wang, Chi-Chuan; Toh, Sengwee (2021). "Building an active medical product safety surveillance system in Taiwan: Adaptation of the U.S. Sentinel System common data model structure to the National Health Insurance Research Database in Taiwan". Pharmacoepidemiology and Drug Safety. pp. 97–101. doi:10.1002/pds.5168.
  18. ^ "COPD, Asthma, and Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies | Sentinel Initiative". Sentinel Initiative.
  19. ^ FitzHenry, F.; Resnic, F. S.; Robbins, S. L.; Denton, J.; Nookala, L.; Meeker, D.; Ohno-Machado, L.; Matheny, M. E. (2015). "Creating a Common Data Model for Comparative Effectiveness with the Observational Medical Outcomes Partnership". Applied Clinical Informatics. pp. 536–547. doi:10.4338/ACI-2014-12-CR-0121.
  20. ^ Xu, Yihua; Zhou, Xiaofeng; Suehs, Brandon T.; Hartzema, Abraham G.; Kahn, Michael G.; Moride, Yola; Sauer, Brian C.; Liu, Qing; Moll, Keran; Pasquale, Margaret K.; Nair, Vinit P.; Bate, Andrew (August 2015). "A Comparative Assessment of Observational Medical Outcomes Partnership and Mini-Sentinel Common Data Models and Analytics: Implications for Active Drug Safety Surveillance". Drug Safety. pp. 749–765. doi:10.1007/s40264-015-0297-5.
  21. ^ Yih, Weiling Katherine; Kulldorff, Martin; Sandhu, Sukhminder K.; Zichittella, Lauren; Maro, Judith C.; Cole, David V.; Jin, Robert; Kawai, Alison Tse; Baker, Meghan A.; Liu, Chunfu; McMahill-Walraven, Cheryl N.; Selvan, Mano S.; Platt, Richard; Nguyen, Michael D.; Lee, Grace M. (May 2016). "Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System". Pharmacoepidemiology and Drug Safety. pp. 481–492. doi:10.1002/pds.3908.
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