Skip to main content

Data Quality in Clinical Research

  • Chapter
  • First Online:
Clinical Research Informatics

Part of the book series: Health Informatics ((HI))

Abstract

Every scientist knows that research results are only as good as the data upon which the conclusions were formed. However, most scientists receive no training in methods for achieving, assessing, or controlling the quality of research data—topics central to clinical research informatics. This chapter covers the basics of collect and process research data given the available data sources, systems, and people. Data quality dimensions specific to the clinical research context are used, and a framework for data quality practice and planning is developed. Available research is summarized, providing estimates of data quality capability for common clinical research data collection and processing methods. This chapter provides researchers, informaticists, and clinical research data managers basic tools to plan, achieve, and control the quality of research data.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 119.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Davis JR, Nolan VP, Woodcock J, Estabrook EW, editors. Assuring data quality and validity in clinical trials for regulatory decision making. Institute of Medicine Workshop report. Roundtable on research and development of drugs, biologics, and medical devices. Washington, DC: National Academy Press; 1999. http://books.nap.edu/openbook.php?record_id=9623&page=R1. Accessed 6 July 2009.

  2. Deming WE, Geoffrey L. On sample inspection in the processing of census returns. J Am Stat Assoc. 1941;36:351–60.

    Article  Google Scholar 

  3. Deming WE, Tepping BJ, Geoffrey L. Errors in card punching. J Am Stat Assoc. 1942;37:525–36.

    Article  Google Scholar 

  4. Donabedian A. A guide to medical care administration, vol. II: medical care appraisal – quality and utilization. New York: American Public Health Association; 1969. 176.

    Google Scholar 

  5. Arndt S, Tyrell G, Woolson RF, Flaum M, Andreasen NC. Effects of errors in a multicenter medical study: preventing misinterpreted data. J Psychiatr Res. 1994;28:447–59.

    Article  PubMed  CAS  Google Scholar 

  6. Juran JM, Gryna FM. Juran’s quality control handbook. 4th ed. New York: McGraw-Hill; 1988.

    Google Scholar 

  7. Guidance for industry E6 good clinical practice: consolidated guidance, ICH E6. April 1996. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf. Accessed Aug 2011.

  8. Reprinted with permission from Data Gone Awry, DataBasics, vol 13, no 3, Fall. 2007. Society for Clinical Data Management. Available from http://www.scdm.org

  9. Nagurney JT, Brown DF, Sane S, Weiner JB, Wang AC, Chang Y. The accuracy and completeness of data collected by prospective and retrospective methods. Acad Emerg Med. 2005;12:884–95.

    Article  PubMed  Google Scholar 

  10. Feinstein AR, Pritchett JA, Schimpff CR. The epidemiology of cancer therapy. 3. The management of imperfect data. Arch Intern Med. 1969;123:448–61.

    Article  PubMed  CAS  Google Scholar 

  11. Reason J. Human error. Cambridge: Cambridge University Press; 1990.

    Google Scholar 

  12. Nahm M, Dziem G, Fendt K, Freeman L, Masi J, Ponce Z. Data quality survey results. Data Basics. 2004;10:7.

    Google Scholar 

  13. Schuyl ML, Engel T. A review of the source document verification process in clinical trials. Drug Info J. 1999;33:789–97.

    Article  Google Scholar 

  14. Batini C, Catarci T, Scannapieco M. A survey of data quality issues in cooperative information systems. In: 23rd international conference on conceptual modeling (ER 2004), Shanghai; 2004.

    Google Scholar 

  15. Pipino L, Lee Y, Wang R. Data quality assessment. Commun ACM. 2002;45:8.

    Google Scholar 

  16. Tayi GK, Ballou DP. Examining data quality. Commun ACM. 1998;41:4.

    Article  Google Scholar 

  17. Redman TC. Data quality for the information age. Boston: Artech House; 1996.

    Google Scholar 

  18. Wand Y, Wang R. Anchoring data quality dimensions in ontological foundations. Commun ACM. 1996;39:10.

    Article  Google Scholar 

  19. Wang R, Strong D. Beyond accuracy: what data quality means to data consumers. J Manage Inform Syst. 1996;12:30.

    Google Scholar 

  20. Batini C, Scannapieco M. Data quality concepts, methodologies and techniques. Berlin: Springer; 2006.

    Google Scholar 

  21. Wyatt J. Acquisition and use of clinical data for audit and research. J Eval Clin Pract. 1995;1:15–27.

    Article  PubMed  CAS  Google Scholar 

  22. U.S. Food and Drug Administration. Guidance for industry. Computerized systems used in clinical trials. In: Services DoHaH, editor. Rockville: U.S. Food and Drug Administration; 2007.

    Google Scholar 

  23. Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc. 2002;9:600–11.

    Article  PubMed  Google Scholar 

  24. (CDISC) CDISC. The Protocol Representation Model version 1.0 draft for public comment: CDISC; 2009. p. 96. Available from http://www.cdisc.org

  25. Jacobs M, Studer L. Forms design II: the course for paper and electronic forms. Cleveland: Ameritype & Art Inc.; 1991.

    Google Scholar 

  26. Eisenstein EL, Lemons PW, Tardiff BE, Schulman KA, Jolly MK, Califf RM. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J. 2005;9:482–8.

    Article  Google Scholar 

  27. Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008;5:75–84.

    Article  PubMed  Google Scholar 

  28. Galešic M. Effects of questionnaire length on response rates: review of findings and guidelines for future research. 2002. http://mrav.ffzg.hr/mirta/Galesic_handout_GOR2002.pdf. Accessed 29 Dec 2009.

  29. Roszkowski MJ, Bean AG. Believe it or not! Longer questionnaires have lower response rates. J Bus Psych. 1990;4:495–509.

    Article  Google Scholar 

  30. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. Increasing response rates to postal questionnaires systematic review. Br Med J. 2002;324:1183.

    Article  Google Scholar 

  31. Wickens CD, Hollands JG. Engineering psychology and human performance. 3rd ed. Upper Saddle River: Prentice Hall; 2000.

    Google Scholar 

  32. Stevens SS. On the theory of scales of measurement. Science. 1946;103:677–80.

    Article  Google Scholar 

  33. Allison JJ, Wall TC, Spettell CM, et al. The art and science of chart review. Jt Comm J Qual Improv. 2000;26:115–36.

    PubMed  CAS  Google Scholar 

  34. Banks NJ. Designing medical record abstraction forms. Int J Qual Health Care. 1998;10:163–7.

    Article  PubMed  CAS  Google Scholar 

  35. Engel L, Henderson C, Fergenbaum J, Interrater A. Reliability of abstracting medical-related information medical record review conduction model for improving. Eval Health Prof. 2009;32:281.

    Article  PubMed  Google Scholar 

  36. Cunningham R, Sarfati D, Hill S, Kenwright D. An audit of colon cancer data on the New Zealand Cancer Registry. N Z Med J. 2008;121(1279):46–56.

    PubMed  Google Scholar 

  37. Fritz A. The SEER program’s commitment to data quality. J Registry Manag. 2001;28(1):35–40.

    Google Scholar 

  38. German RR, Wike JM, Wolf HJ, et al. Quality of cancer registry data: findings from CDC-NPCR’s breast, colon, and prostate cancer data quality and patterns of care study. J Registry Manag. 2008;35(2):67–74.

    Google Scholar 

  39. Herrmann N, Cayten CG, Senior J, Staroscik R, Walsh S, Woll M. Interobserver and intraobserver reliability in the collection of emergency medical services data. Health Serv Res. 1980;15(2):127–43.

    PubMed  CAS  Google Scholar 

  40. Pan L, Fergusson D, Schweitzer I, Hebert PC. Ensuring high accuracy of data abstracted from patient charts: the use of a standardized medical record as a training tool. J Clin Epidemiol. 2005;58(9):918–23.

    Article  PubMed  Google Scholar 

  41. Reeves MJ, Mullard AJ, Wehner S. Inter-rater reliability of data elements from a prototype of the Paul Coverdell National Acute Stroke Registry. BMC Neurol. 2008;8:19.

    Article  PubMed  Google Scholar 

  42. Scherer R, Zhu Q, Langenberg P, Feldon S, Kelman S, Dickersin K. Comparison of information obtained by operative note abstraction with that recorded on a standardized data collection form. Surgery. 2003;133(3):324–30.

    Article  PubMed  Google Scholar 

  43. Stange KC, Zyzanski SJ, Smith TF, et al. How valid are medical records and patient questionnaires for physician profiling and health services research? A comparison with direct observation of patients visits. Med Care. 1998;36(6):851–67.

    Article  PubMed  CAS  Google Scholar 

  44. Thoburn KK, German RR, Lewis M, Nichols PJ, Ahmed F, Jackson-Thompson J. Case completeness and data accuracy in the Centers for Disease Control and Prevention’s National Program of Cancer Registries. Cancer. 2007;109(8):1607–16.

    Article  PubMed  Google Scholar 

  45. To T, Estrabillo E, Wang C, Cicutto L. Examining intra-rater and inter-rater response agreement: a medical chart abstraction study of a community-based asthma care program. BMC Med Res Methodol. 2008;8:29.

    Article  PubMed  Google Scholar 

  46. Yawn BP, Wollan P. Interrater reliability: completing the methods description in medical records review studies. Am J Epidemiol. 2005;161(10):974–7.

    Article  PubMed  Google Scholar 

  47. La France BH, Heisel AD, Beatty MJ. A test of the cognitive load hypothesis: investigating the impact of number of nonverbal cues coded and length of coding session on observer accuracy. Communication Reports. 1 Apr 2007.

    Google Scholar 

  48. Helms Ron. Redundancy: an important data forms/design data collection principle. In: Proceedings Stat computing section, Alexandria; 1981. p. 233–237.

    Google Scholar 

  49. Helms R. Data quality issues in electronic data capture. Drug Inf J. 2001;35:827–37.

    Article  Google Scholar 

  50. U.S. Food and Drug Administration regulations Title 21 CFR Part 58. 2011. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58. Accessed Aug 2011.

  51. Nahm ML, Pieper CF, Cunningham MM. Quantifying data quality for clinical trials using electronic data capture. PLoS One. 2008;3(8):e3049.

    Article  PubMed  Google Scholar 

  52. Winchell T. The mystery of source documentation. SOCRA Source 62. 2009. Available from http://www.socra.org/.

  53. Nahm, M. Data Accuracy in Medical Record Abstraction. Doctoral Dissertation, University of Texas at Houston, School of Biomedical Informatics, Houston Texas, May 6, 2010.

    Google Scholar 

  54. SCDM. Good clinical data management practices. http://www.scdm.org. Society for Clinical Data Management; 2010. Available from http://www.scdm.org

  55. Rostami R, Nahm M, Pieper CF. What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997–2006. Clin Trials. 2009;6(2):141–50.

    Article  PubMed  Google Scholar 

  56. Svolba G, Bauer P. Statistical quality control in clinical trials. Control Clin Trials. 1999;20(6):519–30.

    Article  PubMed  CAS  Google Scholar 

  57. Chilappagari S, Kulkarni A, Bolick-Aldrich S, Huang Y, Aldrich TE. A statistical process control method to monitor completeness of central cancer registry reporting data. J Registry Manag. 2002;29(4):121–7.

    Google Scholar 

  58. Chiu D, Guillaud M, Cox D, Follen M, MacAulay C. Quality assurance system using statistical process control: an implementation for image cytometry. Cell Oncol. 2004;26(3):101–17.

    PubMed  Google Scholar 

  59. McNees P, Dow KH, Loerzel VW. Application of the CuSum technique to evaluate changes in recruitment strategies. Nurs Res. 2005;54(6):399–405.

    Article  PubMed  Google Scholar 

  60. Baigent C, Harrell FE, Buyse M, Emberson JR, Altman DG. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials. 2008;5(1):49–55.

    Article  PubMed  Google Scholar 

  61. Matheny ME, Morrow DA, Ohno-Machado L, Cannon CP, Sabatine MS, Resnic FS. Validation of an automated safety surveillance system with prospective, randomized trial data. Med Decis Making. 2009;29(2):247–56.

    Article  PubMed  Google Scholar 

  62. Freedman LS, Schatzkin A, Wax Y. The impact of dietary measurement error on planning sample size required in a cohort study. Am J Epidemiol. 1990;132:1185–95.

    PubMed  CAS  Google Scholar 

  63. Perkins DO, Wyatt RJ, Bartko JJ. Penny-wise and pound-foolish: the impact of measurement error on sample size requirements in clinical trials. Biol Psychiatry. 2007;47:762–6.

    Article  Google Scholar 

  64. Mullooly JP. The effects of data entry error: an analysis of partial verification. Comput Biomed Res. 1990;23:259–67.

    Article  PubMed  CAS  Google Scholar 

  65. Liu K. Measurement error and its impact on partial correlation and multiple linear regression analyses. Am J Epidemiol. 1988;127:864–74.

    PubMed  CAS  Google Scholar 

  66. Stepnowsky Jr CJ, Berry C, Dimsdale JE. The effect of measurement unreliability on sleep and respiratory variables. Sleep. 2004;27:990–5.

    PubMed  Google Scholar 

  67. Myer L, Morroni C, Link BG. Impact of measurement error in the study of sexually transmitted infections. Sex Transm Infect. 2004;80(318–323):328.

    Google Scholar 

  68. Williams SC, Watt A, Schmaltz SP, Koss RG, Loeb JM. Assessing the reliability of standardized performance indicators. Int J Qual Health Care. 2006;18:246–55.

    Article  PubMed  Google Scholar 

  69. Watt A, Williams S, Lee K, Robertson J, Koss RG, Loeb JM. Keen eye on core measures. Joint Commission data quality study offers insights into data collection, abstracting processes. J AHIMA. 2003;74:20–5; quiz 27–8.

    PubMed  Google Scholar 

  70. US Government Accountability Office. Hospital quality data: CMS needs more rigorous methods to ensure reliability of publicly released data. In: Office UGA, editor. Washington, DC; 2006. www.gao.gov/new.items/d0654.pdf

  71. Braun BI, Kritchevsky SB, Kusek L, et al. Comparing bloodstream infection rates: the effect of indicator specifications in the evaluation of processes and indicators in infection control (EPIC) study. Infect Control Hosp Epidemiol. 2006;27:14–22.

    Article  PubMed  Google Scholar 

  72. Jacobs R, Goddard M, Smith PC. How robust are hospital ranks based on composite performance measures? Med Care. 2005;43:1177–84.

    Article  PubMed  Google Scholar 

  73. Pagel C, Gallivan S. Exploring consequences on mortality estimates of errors in clinical databases. IMA J Manage Math. 2008;20(4):385–93. http://imaman.oxfordjournals.org/content/20/4/385.abstract

    Article  Google Scholar 

  74. Goldhill DR, Sumner A. APACHE II, data accuracy and outcome prediction. Anaesthesia. 1998;53:937–43.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Meredith Nahm Ph.D. .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2012 Springer-Verlag London Limited

About this chapter

Cite this chapter

Nahm, M. (2012). Data Quality in Clinical Research. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, London. https://doi.org/10.1007/978-1-84882-448-5_10

Download citation

  • DOI: https://doi.org/10.1007/978-1-84882-448-5_10

  • Published:

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84882-447-8

  • Online ISBN: 978-1-84882-448-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics