Advertisement

Data Collection and Management in Clinical Research

Chapter

Abstract

Well-designed trials and data management methods are essential to the integrity of the findings from clinical trials, and the completeness, accuracy, and timeliness of data collection are key indicators of the quality of conduct of the study. The research data provide the information to be analyzed in addressing the study objectives, and addressing the primary objectives is the critical driver of the study. Since the data management plan closely follows the structure and sequence of the protocol, the data management group and protocol development team must work closely together. Accurate, thorough, detailed, and complete collection of data is critical, especially at baseline as this is the last time observations can be recorded before the effects of the trial interventions come into play. The shift from paper-based to electronic systems promotes efficient and uniform collection of data and can build quality control into the data collection process.

Keywords

Case Report Form Source Document Double Data Entry Site Staff Electronic Data Capture 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.

References

  1. 1.
    Liu EW. Clinical research the six sigma way. JALA. 2006;11:42–9.Google Scholar
  2. 2.
    Brandt CA, Argraves S, Money R, Ananth S, Trocky NM, Nadkarni PM. Informatics tools to improve clinical research study implementation. Contemp Clin Trials. 2006;27:112–22.PubMedCrossRefGoogle Scholar
  3. 3.
    Piantadosi S. Clinical trials. A methodologic perspective. 2nd ed. Hoboken: Wiley; 2005.CrossRefGoogle Scholar
  4. 4.
    McFadden E. Data definition, forms, and database design. In: Management of data in clinical trials. 2nd ed. New York: Wiley; 2007.CrossRefGoogle Scholar
  5. 5.
    Roberts P. Reliability and validity in research. Nurs Stand. 2006;20:41–5.Google Scholar
  6. 6.
    Williams GW. The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clin Trials. 2006;3:530–7.PubMedCrossRefGoogle Scholar
  7. 7.
    Crerand WJ, Lamb J, Rulon V, Karal B, Mardekian J. Building data quality into clinical trials. J AHIMA. 2002;73:44–56.PubMedGoogle Scholar
  8. 8.
    Guidance for industry: electronic source documentation in clinical investigations. Rockville: Food and Drug Administration (US). 2010. Office of Commu­nication, Outreach and Development, HFM-40. Accessed 28 Oct 2011.Google Scholar
  9. 9.
    Kush R, Alschuler L, Ruggeri R, Cassells S, Gupta N, Bain L, Claise K, Shah M, Nahm M. Implementing Single Source: the STARBRITE proof-of-concept study. J Am Med Inform Assoc. 2007;14:662–73.PubMedCrossRefGoogle Scholar
  10. 10.
    Takayanagi R, Watanabe K, Nakahara A, Nakamura H, Yamada Y, Suzuki H, Arakawa Y, Omata M, Iga T. Items of concern associated with source document verification of clinical trials for new drugs. Yakugaku Zasshi. 2004;124:89–92.PubMedCrossRefGoogle Scholar
  11. 11.
    Bernd CL. Clinical case report forms design—a key to clinical trial success. Drug Inf J. 1984;18:3–8.PubMedGoogle Scholar
  12. 12.
    US Food and Drug Administration. Code of Federal Regulations:21CFR11.10. Title 21—food and drugs. Chapter I, subchapter A—general. Part 11—electronic records; electronic signatures. Subpart B—electronic records. Sec. 11.10—controls for closed systems. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=11.10. Accessed 25 Feb 2008.
  13. 13.
    Meadows BJ. Eliciting remote data entry system requirements for the collection of cancer clinical trial data. Comput Inform Nurs. 2003;21:234–40.PubMedCrossRefGoogle Scholar
  14. 14.
    Welker JA. Implementation of electronic data capture systems: barriers and solutions. Contemp Clin Trials. 2007;28:329–36.PubMedCrossRefGoogle Scholar
  15. 15.
    Kashner TM, Hinson R, Holland GJ, Mickey DD, Hoffman K, Lind L, Johnson LD, Chang BK, Golden RM, Henley SS. A data accounting system for clinical investigators. J Am Med Inform Assoc. 2007;14:394–6.PubMedCrossRefGoogle Scholar
  16. 16.
    Argraves S, Brandt CA, Money R, Nadkarni P. Informatics tools to improve clinical research. In: Proceedings of the American Medical Informatics Association Symposium, 22–26 Oct 2005; Washington, DC.Google Scholar
  17. 17.
    Kawado M, Hinotsu S, Matsuyama Y, Yamaguchi T, Hashimoto S, Ohashi Y. A comparison of error detection rates between the reading aloud method and the double data entry method. Control Clin Trials. 2003;24:560–9.PubMedCrossRefGoogle Scholar
  18. 18.
    King DW, Lashley R. A quantifiable alternative to double data entry. Control Clin Trials. 2000;21:94–102.PubMedCrossRefGoogle Scholar
  19. 19.
    Day S, Fayers P, Harvey D. Double data entry: what value, what price? Control Clin Trials. 1998;19:15–24.PubMedCrossRefGoogle Scholar
  20. 20.
    McFadden E. Software tools for trials management. In: Management of data in clinical trials. 2nd ed. New York: Wiley; 2007.CrossRefGoogle Scholar
  21. 21.
    Trocky NM, Fontinha M. Quality management tools: facilitating clinical research data integrity by utilizing specialized reports with electronic case report forms. In: Proceedings of the American Medical Informatics Association Symposium, 22–26 Oct 2005; Washington, DC.Google Scholar
  22. 22.
    Saw SM, Lim SG. Clinical drug trials: practical problems of phase III. Ann Acad Med Singapore. 2000;29:598–605.PubMedGoogle Scholar
  23. 23.
  24. 24.
    Department of Health and Human Services. IRB Guidebook Chapter IV: Consideration of research design, 2007. http://www.hhs.gov/ohrp/irb/irb_chapter4.htm. Accessed 25 Apr 2008.
  25. 25.
    US Food and Drug Administration. Code of Federal Regulations: 21CFR56.115. Title 21—Food and drugs. Chapter I, subchapter A—general. Part 56—institutional review boards. Subpart D—records and reports. Sec. 56.115—IRB records. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.115. Accessed 24 Feb 2008.
  26. 26.
    US Food and Drug Administration. Code of Federal Regulations: 21CFR312.59. Title 21—Food and drugs. Chapter I, subchapter D—drugs for human use. Part 312—investigational new drug application. Subpart D—responsibilities of sponsors and investigators. Sec. 312.59 —disposition of unused supply of investigational drug. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.59. Accessed 24 Feb 2008.
  27. 27.
    US Food and Drug Administration. Code of Federal Regulations: 21CFR312.61 Investigational New Drug Application. Title 21—Food and drugs. Chapter I, subchapter D—drugs for human use. Part 312—investigational new drug application. Subpart D—responsibilities of sponsors and investigators. Sec. 312.61—control of the investigational drug. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.61. Accessed 24 Feb 2008.
  28. 28.
    US Food and Drug Administration. Code of Federal Regulations: 21CFR312.62. Title 21—Food and drugs. Chapter I, subchapter D—drugs for human use. Part 312—investigational new drug application. Subpart D—responsibilities of sponsors and investigators. Sec. 312.62—investigator recordkeeping and record retention. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62. Accessed 24 Feb 2008.
  29. 29.
    Siden R, Tankanow RM, Tamer HR. Understanding and preparing for clinical drug trial audits. Am J Health Syst Pharm 2002;59:2301,2306,2308.Google Scholar
  30. 30.
    DDOTS, Inc. IDEA Web-based software for investigational drug inventory management. http://www.ddots.com/idea_product_overview.cfm. Accessed 24 Feb 2008.
  31. 31.
    Department of Health and Human Services. IRB Guidebook Chapter III: Basic IRB Review. 2007. http://www.hhs.gov/ohrp/irb/irb_chapter3.htm. Accessed 25 Apr 2008.

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  1. 1.Synergy Research IncIrvineUSA

Personalised recommendations