Clinical Research Systems and Integration with Medical Systems

  • Joyce C. Niland
  • Layla Rouse


Integration of the Electronic Medical Records (EMR) with clinical research systems has the potential to greatly enhance the efficiency, speed, and safety of cancer research. New hypotheses could be generated through mining of EMR data, observational studies may be conducted more rapidly, and clinical trial recruitment and conduct could be greatly facilitated. Such enhancements will be accomplished through secondary use of EMR data for research and the development of automated decision support systems that rely on EMR data. In this chapter, we define the various types of EMR and clinical research data systems in use and describe the goals and rationale for integrating these two types of systems to enhance research as well as quality of care. The various approaches and benefits to integrating EMR and clinical research systems are discussed. While major benefits are conferred by such system integration, many challenges exist as well, such as the need for stringent data quality assurance, appropriate granularity, metadata and person index management, and extremely careful handling of data access and security issues. Furthermore, the movement toward the EMR within the USA has been slow to date, hampering these data integration efforts. However, recent legislation to incentivize the adoption of EMRs will make the feasibility and utility of EMR data integration to support clinical research more promising in the near future.


Electronic Medical Record National Comprehensive Cancer Network Electronic Health Record Health Information Technology Electronic Medical Record System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. Accredited Standards Committee (ASC) X12. Retrieved 17 August 2009.
  2. Adelman S, Moss LT (2000) Data warehouse project management. Addison-Wesley, Upper Saddle River, NJGoogle Scholar
  3. American National Standards Institute Accredited Standards Committee X12 (ANS ASC X12). In: Wikipedia, the free encyclopedia. Retrieved 12 August 2009 from
  4. Anonymous (1993) Users and uses of patient records. Report of the Council on Scientific Affairs, American Medical Association. Arch Fam Med 2(6):678–681CrossRefGoogle Scholar
  5. Automated Decision Support Systems (ADSS). In: Wikipedia, the free encyclopedia. Retrieved August 4, 2009 from
  6. Biomedical Research Integrated Domain Group (BRIDG). Retrieved 17 August 2009.
  7. Brown JS, Semradek J (1992) Secondary data on health-related subjects: major sources, uses, and limitations. Public Health Nurs 9(3):162–171PubMedCrossRefGoogle Scholar
  8. CDC National Center for Health Statistics (2006) More physicians using medical records. Accessed 20 August 2009
  9. Center for Medicare and Medicaid Services (CMS) Fact Sheet (2009) Medicare and medicaid health information technology: Title IV of the American recovery and reinvestment act. Retrieved 12 August 2009.
  10. Certification Commission for Health Information Technology (CCHIT). Retrieved 17 August 2009.
  11. Certification Commission for Healthcare Information Technology (CCHIT). In: Wikipedia, the free encyclopedia. Retrieved August 4, 2009 from
  12. Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, Hunscher D, Clauw D (2005) Usability comparison of three clinical trial management systems. AMIA Annu Symp Proc 2005:921Google Scholar
  13. Clinical Data Interchange Standards Consortium (CDISC) (2009) Retrieved 15 August 2009.
  14. Clinical Data Management System (CDMS). In: Wikipedia, the free encyclopedia. Retrieved 4 August 2009 from
  15. Digital Imaging and Communications in Medicine. In: Wikipedia, the free encyclopedia. Retrieved 12 August 2009 from
  16. Electronic Data Capture (EDC). In: Wikipedia, the free encyclopedia. Retrieved 4 August 2009 from
  17. Electronic Health Record (EHR). In; Wikipedia, the free encyclopedia. Retrieved 4 August 2009 from
  18. Electronic Medical Record (EMR). Electronic Data Capture (EDC). In: Wikipedia, the free encyclopedia. Retrieved 4 August 2009 from
  19. Gray P, Watson HJ (1998) Decision support in data warehouse. Prentice Hall, Upper Saddle River, NJGoogle Scholar
  20. Greenes RA, Pappalardo AN, Marble CW, Barnett GO (1969) Design and implementation of a clinical data management system. Comput Biomed Res 2(5):469–485PubMedCrossRefGoogle Scholar
  21. Hammond WE, Hales JW, Lobach DF, Straube MJ (1997) Integration of a computer-based patient record system into the primary care setting. Comput Nurs 15(2 Supp 1):S61–S68PubMedGoogle Scholar
  22. Handleman D (2005) Electronic data capture: when will it replace paper? Retrieved 4 August 2009.
  23. Health Information Privacy. In: U.S. Department of Health & Human Services. Retrieved 12 August 2009.
  24. Health Information Technology for Economic and Clinical Health (HITECH) Act (2009) H.R.1 – American Recovery and Reinvestment Act of 2009. Retrieved 20 August 2009.
  25. Health Insurance Portability and Accountability Act. In: Wikipedia, the free encyclopedia. Retrieved 12 August 2009 from
  26. Health Level Seven (HL7). Retrieved 17 August 2009.
  27. Health Level Seven (HL7). In: Wikipedia, the free encyclopedia. Retrieved 15 August 2009 from
  28. Iezzoni L (1997) Risk adjustment for measuring health care outcomes. Health Administration Press, Chicago, ILGoogle Scholar
  29. Institute of Medicine (1991) The computer-based patient record: an essential technology for health care. National Academy Press, Washington, DCGoogle Scholar
  30. Medicare Part B Imaging Services (2008) United States government accountability office report to congressional requesters. Accessed 20 August 2009
  31. National Archives and Records Administration (2008) Long-term usability of optical media. Retrieved 20 August 2009.
  32. National Cancer Institute. Electronic Medical Record, Dictionary of Cancer Terms. Retrieved 19 August 2009.
  33. National Center for Health Statistics (2006) Electronic medical record use by office-based physicians, United States, 2005. Accessed 20 August 2009
  34. National Library of Medicine (2009) National Institutes of Health, Unified Medical Language System, RxNorm. Retrieved 19 August 2009.
  35. Niland JC (1998) NCCN internet-based data system for the conduct of outcomes research. Oncology 12:11Google Scholar
  36. Niland J, Rouse L (2006) Clinical research needs. In: Lehmann H, Abbott P, Roderer N et al (eds) Aspects of electronic health record-system, 2nd edn. Springer, New YorkGoogle Scholar
  37. Niland JC, Rouse L, Stahl DC (2006) An informatics blueprint for healthcare quality. J Am Med Assoc 13(4):402–417CrossRefGoogle Scholar
  38. Niland JC, Pannoni S, Neat J, Sarbora R, Lee J (2007). Cancer Automated Lab Adverse Event Grading Service (CALAEGS). American Medical Informatics Association ‘Clinical Research Informatics EXPO’ Posters and DemonstrationsGoogle Scholar
  39. Payne PR, Greaves AW, Kipps TJ (2003) CRC Clinical Trials Management System (CTMS): an integrated information management solution for collaborative clinical research. AMIA Annu Symp Proc 2003:967Google Scholar
  40. Powell J, Buchan I (2005) Electronic health records should support clinical research. J Am Med Internet Res 7(1):e4CrossRefGoogle Scholar
  41. Rangachari P (2007) Coding for quality measurement: the relationship between hospital structural characteristics and coding accuracy from the perspective of quality measurement. Perspect Health Inf Manag 4:3PubMedGoogle Scholar
  42. Robertson J (2003) Cardiovascular point of care initiative: enhancements in clinical data management. Qual Manag Health Care 12(2):115–121PubMedGoogle Scholar
  43. Safran C, Bloomrosen M, Hammond WE, Labkoff S, Markel-Fox S, Tang PC, Detmer DE (2007) Toward a national framework for the secondary use of health data: An American informatics association white paper. J Am Med Assoc 14:1–9Google Scholar
  44. Stam H, van Ginneken AM (1995) Computer-based patient record with a cardiologic extension. Medinfo 8(Pt 2):1666PubMedGoogle Scholar
  45. Summerhayes S (2002) CDM regulations procedures manual. Blackwell, LondonCrossRefGoogle Scholar
  46. Tai BC, Seldrup J (2000) A review of software for data management, design and analysis of clinical trials. Ann Acad Med Singapore 29(5):576–581PubMedGoogle Scholar
  47. Thiru K, Hassey A, Sullivan F (2003) Systematic review of scope and quality of electronic patient record data in primary care. Br Med J 326:1070CrossRefGoogle Scholar
  48. Turban E, Leidner D, McLean E, Wetherbe J (1997) Information technology for management: transforming organizations in the digital economy, 6th edn. Wiley, Danvers, MAGoogle Scholar
  49. Winkelman WJ, Leonard KJ (2004) Overcoming structure constraints to patient utilization of electronic medical records: a critical review and proposal for an evaluation framework. J Am Med Inform Assoc 11:151–161PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.City of Hope National Medical CenterDuarteUSA

Personalised recommendations