Skip to main content

Data Collection and Quality Control

  • Chapter
  • First Online:
Fundamentals of Clinical Trials

Abstract

No study is better than the quality of its data. Data in clinical trials are collected from several sources – interviews, questionnaires, participant examinations, or laboratory determinations. Also, data that have been collected and evaluated by someone outside the study may be used in a trial; for example, diagnoses obtained from death certificates or hospital records.

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 54.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. ICH E6. Good clinical practice: Consolidated guideline, Step 5 as of May 1996. http://www.ich.org.

  2. International Conference on Harmonisation. September 2007. http://www.ich.org.

  3. Knatterud GL, Rockhold FW, George SL, et al. Guidelines for quality assurance in multicenter trials: A position paper. Control Clin Trials 1998;19:477–493.

    Article  Google Scholar 

  4. Williams GW. The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clin Trials 2006;3:530–537.

    Article  Google Scholar 

  5. Zon R, Meropol NJ, Catalano RB, Schilsky RL. American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol 2008;26:2562–2567.

    Article  Google Scholar 

  6. Devine S, Dagher RN, Weiss KD, Santana VM. Good clinical practice and the conduct of clinical studies in pediatric oncology. Pediatr Clin North Am 2008;55:187–208.

    Article  Google Scholar 

  7. Baigent C, Harrell FE, Buyse M, et al. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials 2008;5:49–55.

    Article  Google Scholar 

  8. Acosta CJ, Galindo CM, Ochiai RL, et al. Implementation of good clinical practice guidelines in vaccine trials in developing countries. Vaccine 2007;25:2852–2857.

    Article  Google Scholar 

  9. McFadden E. Management of Data in Clinical Trials. Hoboken, New Jersey: John Wiley & Sons, 2007.

    Book  Google Scholar 

  10. Meinert CL. Clinical Trials: Design, Conduct, and Analysis. New York: Oxford University Press, 1986.

    Book  Google Scholar 

  11. Neaton JD, Bartsch GE, Broste SK, et al. A case of data alteration in the Multiple Risk Factor Intervention Trial (MRFIT). Control Clin Trials 1991;12:731–740.

    Article  Google Scholar 

  12. Fisher B, Redmond CK. Fraud in breast-cancer trials. N Engl J Med 1994;330:1458–1462.

    Article  Google Scholar 

  13. Koran LM. The reliability of clinical methods, data and judgments. Part 1. N Engl J Med 1975;293:642–646.

    Article  Google Scholar 

  14. Koran LM. The reliability of clinical methods, data and judgments. Part 2. N Engl J Med 1975;293:695–701.

    Article  Google Scholar 

  15. Belk WP, Sunderman FW. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol 1947;17:853–861.

    Google Scholar 

  16. Westgard JO. Basic Method Validation. Madison, Wisconsin: Westgard QC, Inc., 2003, pp 102–103.

    Google Scholar 

  17. McPherson RA, Pincus MR (eds.). Henry’s Clinical Diagnosis and Management by Laboratory Methods (21st Edition). Philadelphia: Elsevier Saunders, Inc., 2007, pp 4–5.

    Google Scholar 

  18. Gur D, Bandos AI, Cohen CS, et al. The “laboratory” effect: Comparing radiologists’ performance and variability during prospective clinical and laboratory mammography interpretations. Radiology 2008;249:47–53.

    Article  Google Scholar 

  19. Panicker GK, Karnad DR, Natekar M, et al. Intra- and interreader variability in QT interval measurement by tangent and threshold methods in central electrocardiogram laboratory. J Electrocardiol 2009;42:348–352.

    Article  Google Scholar 

  20. Fridsma DB, Evans J, Hastak S, Mead CN. The BRIDG project: A technical report. J Am Med Inform Assoc 2008;15:130–137.

    Article  Google Scholar 

  21. Weng C, Gennari JH, Fridsma DB. User-centered semantic harmonization: A case study. J Biomed Inform 2007;40:353–364.

    Article  Google Scholar 

  22. Moyers S, Richesson R, Krischer J. Trans-atlantic data harmonization in the classification of medicines and dietary supplements: A challenge for epidemiologic study and clinical research. Int J Med Inform 2008;77:58–67.

    Article  Google Scholar 

  23. Luepker RV, Evans A, McKeigue P, Reddy KS. Cardiovascular Survey Methods (3rd Edition). Geneva, Switzerland: World Health Organization, 2004.

    Google Scholar 

  24. Cook TD, DeMets DL. Data collection and quality control. In Cook TD, DeMets DL (eds.). Introduction to Statistical Methods for Clinical Trials. Boca Raton, Florida: Chapman & Hall/CRC, 2007, pp 171–200.

    Google Scholar 

  25. Kahn HA, Leibowitz H, Gauley JP, et al. Standardizing diagnostic procedures. Am J Ophthalmol 1975;79:768–775.

    Google Scholar 

  26. Neaton JD, Duchene AG, Svendson KH, Wentworth D. An examination of the efficacy of some quality assurance methods commonly employed in clinical trials. Stat Med 1990;9:115–124.

    Article  Google Scholar 

  27. Furberg CD, Byington RP, Craven TE. Lessons learned from clinical trials with ultrasound endpoints. J Intern Med 1994;236:575–580.

    Article  Google Scholar 

  28. Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 2009;6:239–251.

    Article  Google Scholar 

  29. Reboussin D, Espeland MA. The science of web-based clinical trial management. Clin Trials 2005;2:1–2.

    Article  Google Scholar 

  30. Litchfield J, Freeman J, Schou H, et al. Is the future for clinical trials internet-based? A cluster randomized clinical trial. Clin Trials 2005;2:72–79.

    Article  Google Scholar 

  31. Winget M, Kincaid H, Lin P, et al. A web-based system for managing and co-ordinating multiple multisite studies. Clin Trials 2005;2:42–49.

    Article  Google Scholar 

  32. Schmidt JR, Vignati AJ, Pogash RM, et al. Web-based distributed data management in the Childhood Asthma Research and Education (CARE) Network. Clin Trials 2005;2:50–60.

    Article  Google Scholar 

  33. Mitchell R, Shah M, Ahmad S, et al. for the Adolescent Medicine Trials Network for HIV/AIDS interventions. A unified web-based query and notification system (QNS) for subject management, adverse events, regulatory, and IRB components of clinical trials. Clin Trials 2005;2:61–71.

    Google Scholar 

  34. Eisenstein EL, Lemons II PW, Tardiff BE, et al. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J 2005;149:482–488.

    Article  Google Scholar 

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

    Article  Google Scholar 

  36. Lachin JM. The role of measurement reliability in clinical trials. Clin Trials 2004;1:553–566.

    Article  Google Scholar 

  37. Weiss RB, Vogelzang NJ, Peterson BA, et al. A successful system of scientific data audits for clinical trials. JAMA 1993;270:459–464.

    Article  Google Scholar 

  38. Weiss RB. Systems of protocol review, quality assurance, and data audit. Cancer Chemother Pharmacol 1998;42(suppl):S88–S92.

    Article  Google Scholar 

  39. Soran A, Nesbitt L, Mamounas EP, et al. Centralized medical monitoring in phase III clinical trials: The National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Clin Trials 2006;3:478–485.

    Article  Google Scholar 

  40. Reynolds SM. ORI findings of scientific misconduct in clinical trials and publicly funded research, 1992-2002. Clin Trials 2004;1:509–516.

    Article  Google Scholar 

  41. Department of Health and Human Services. Public Health Service policies on research misconduct. Final rule. Fed Regist 2005;70:28370–28400.

    Google Scholar 

  42. Karlberg JPE. US FDA site inspection findings, 1997-2008, fail to justify globalization concerns. Clin Trial Magnifier 2009;2:194–212.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lawrence M. Friedman .

Rights and permissions

Reprints and permissions

Copyright information

© 2010 Springer New York

About this chapter

Cite this chapter

Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). Data Collection and Quality Control. In: Fundamentals of Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1586-3_11

Download citation

Publish with us

Policies and ethics