Table of Contents
Advances in Software Engineering
Volume 2013, Article ID 796505, 13 pages
http://dx.doi.org/10.1155/2013/796505
Research Article

A New Software Development Methodology for Clinical Trial Systems

Department of Applied Mathematics, Chung Yuan Christian University, 200 Chung Pei Road, Chung Li 32023, Taiwan

Received 29 October 2012; Revised 14 January 2013; Accepted 25 February 2013

Academic Editor: Pekka Abrahamsson

Copyright © 2013 Li-Min Liu. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. R. Tiruvoipati, S. P. Balasubramanian, G. Atturu, G. J. Peek, and D. Elbourne, “Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward,” Journal of Thoracic and Cardiovascular Surgery, vol. 132, no. 2, pp. 233–240, 2006. View at Publisher · View at Google Scholar · View at Scopus
  2. US FDA, “Final rule for good laboratory practice regulations,” Federal Register, vol. 52, pp. 33768–33782, 1987. View at Google Scholar
  3. R. D. Kush, P. Bleicher, W. R. Kubick et al., eClinical Trials: Planning and Implementation, Thomson CenterWatch, Boston, Mass, USA, 2003.
  4. L. Clivio, A. Tinazzi, S. Mangano, and E. Santoro, “The contribution of information technology: towards a better clinical data management,” Drug Development Research, vol. 67, no. 3, pp. 245–250, 2006. View at Publisher · View at Google Scholar · View at Scopus
  5. T. H. Payne and G. Graham, “Managing the life cycle of electronic clinical documents,” Journal of the American Medical Informatics Association, vol. 13, no. 4, pp. 438–445, 2006. View at Google Scholar
  6. T. Schleyer, H. Spallek, and P. Hernández, “A qualitative investigation of the content of dental paper-based and computer-based patient record formats,” Journal of the American Medical Informatics Association, vol. 14, no. 4, pp. 515–526, 2007. View at Publisher · View at Google Scholar · View at Scopus
  7. T. J. Kuhn, “The difference between eDC and eCRF,” http://tjkuhn.wordpress.com/2008/03/14/the-difference-between-edc-and-ecrf.
  8. G. Nahler, Dictionary of Pharmaceutical Medicine, Springer, New York, NY, USA, 2009.
  9. B. Ene-Iordache, S. Carminati, L. Antiga et al., “Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial,” Journal of the American Medical Informatics Association, vol. 16, no. 3, pp. 404–408, 2009. View at Publisher · View at Google Scholar · View at Scopus
  10. I. Pavlovic, T. Kern, and D. Miklavcic, “Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study,” Contemporary Clinical Trials, vol. 30, pp. 300–316, 2009. View at Google Scholar
  11. R. Kush, L. Alschuler, R. Ruggeri et al., “Implementing single source: the STARBRITE proof-of-concept study,” Journal of the American Medical Informatics Association, vol. 14, no. 5, pp. 662–673, 2007. View at Publisher · View at Google Scholar · View at Scopus
  12. D. Kim, S. Labkoff, and S. H. Holliday, “Opportunities for electronic health record data to support business functions in the pharmaceutical industry–A case study from Pfizer, Inc.,” Journal of the American Medical Informatics Association, vol. 15, no. 5, pp. 581–584, 2008. View at Publisher · View at Google Scholar · View at Scopus
  13. K Yamamoto, S. Matsumoto, H. Tada et al., “A data capture system for outcomes studies that integrates with electronic health records: development and potential uses,” Journal of Medical Systems, vol. 32, no. 5, pp. 423–427, 2008. View at Google Scholar
  14. Integrating the Healthcare Enterprise International. IHE IT Infrastructure Technical Framework Supplement—RFD supplement, http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Suppl_RFD_TI_2006_09_25.pdf.
  15. J. R. Deitzer, P. R. Payne, and J. B. Starren, “Coverage of clinical trials tasks in existing ontologies,” in AMIA Annual Symposium Proceedings, p. 903, 2006. View at Scopus
  16. R. H. Dolin, L. Alschuler, S. Boyer et al., “HL7 clinical document architecture, release 2,” Journal of the American Medical Informatics Association, vol. 13, no. 1, pp. 30–39, 2006. View at Publisher · View at Google Scholar · View at Scopus
  17. R. L. Richesson, J. E. Andrews, and J. P. Krischer, “Use of SNOMED CT to represent clinical research data: a semantic characterization of data items on case report forms in vasculitis research,” Journal of the American Medical Informatics Association, vol. 13, no. 5, pp. 536–546, 2006. View at Publisher · View at Google Scholar · View at Scopus
  18. J. E. Andrews, R. L. Richesson, and J. Krischer, “Variation of SNOMED CT coding of clinical research concepts among coding experts,” Journal of the American Medical Informatics Association, vol. 14, no. 4, pp. 497–506, 2007. View at Publisher · View at Google Scholar · View at Scopus
  19. M. W. Haber, B. W. Kisler, M. Lenzen, and L. W. Wright, “Controlled terminology for clinical research: a collaboration between CDISC and NCI enterprise vocabulary services,” Drug Information Journal, vol. 41, no. 3, pp. 405–412, 2007. View at Google Scholar · View at Scopus
  20. CDISC, http://www.cdisc.org/.
  21. T. Strasser and G. Lotz, “An integrated system for workflow and data management in clinical trials,” Investigative Ophthalmology & Visual Science, vol. 49, E-Abstract 5216, 2008. View at Google Scholar
  22. US FDA, “21 CFR Part 11: electronic records; electronic signatures; final rule,” Federal Register, vol. 62, no. 54, p. 13429, 1997. View at Google Scholar
  23. B. Boehm, “Get ready for agile methods, with care,” Computer, vol. 35, no. 1, pp. 64–69, 2002. View at Publisher · View at Google Scholar · View at Scopus
  24. R. S. Pressman, Software Engineering: A Practitioner's Approach (7/e), McGraw-Hill Inc., New York, NY, USA, 2009.
  25. W. Royce, “Managing the development of large software systems: concepts and techniques,” in Proceedings of the WESCON, 1970.
  26. H. Mills, “Top-down programming in large systems,” in Debugging Techniques in Large Systems, R. Ruskin, Ed., Prentice Hall, Upper Saddle River, NJ, USA, 1971. View at Google Scholar
  27. L. Bally, J. Brittan, and K. H. Wagner, “A prototype approach to information system design and development,” Information and Management, vol. 1, no. 1, pp. 21–26, 1977. View at Google Scholar · View at Scopus
  28. B. W. Boehm, “Spiral model for software development and enhancement,” Computer, vol. 21, no. 5, pp. 61–72, 1988. View at Publisher · View at Google Scholar · View at Scopus
  29. J. Wood and D. Silver, Joint Application Development, Wiley, New York, NY, USA, 1995.
  30. I. Jacobson, G. Booch, and J. Rumbaugh, The Unified Software Development Process, Addison-Wesley, Boston, Mass, USA, 1999.
  31. J. Highsmith, Agile Software Development Ecosystems, Addison-Wesley, Reading, Mass, USA, 2002.
  32. IBM Rational Unified Process (RUP), http://www-01.ibm.com/software/awdtools/rup/.
  33. I. Jacobson, G. Booch, and J. Rumbaugh, The Unified Software Development Process, Addison-Wesley, Boston, Mass, USA, 1999. View at Scopus
  34. G. Booch, J. Rumbaugh, and I. Jacobson, The Unified Modeling Language User Guide, Addison-Wesley, Reading, Mass, USA, 2nd edition, 2005.
  35. US FDA, “Running Clinical Trials,” http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.
  36. US FDA, 21 CFR Part 820: Quality System Regulation; 2007.
  37. Oracle Clinical, http://www.oracle.com/us/industries/life-sciences/clinical/overview/index.html.
  38. Java Platform, http://www.oracle.com/technetwork/java/javase/overview/index.html.
  39. Microsoft.Net, http://www.microsoft.com/net/.
  40. S. Bennett, M. Myatt et al., “Data Management for Surveys and Trials: A Practical Primer Using Epidata,” http://www.epidata.dk/downloads/dmepidata.pdf.
  41. H. Mills, “Top-down programming in large systems,” in Debugging Techniques in Large Systems, R. Ruskin, Ed., Prentice Hall, Upper Saddle River, NJ, USA, 1971. View at Google Scholar
  42. J. Mcdermid and P. Rook, Software Development Process Models. Software Engineer's Reference Book, CRC Press, 1993.
  43. L. Maciaszek, Practical Software Engineering: A Case-Study Approach (8/e), Addison-Wesley, Reading, Mass, USA, 2004.
  44. I. Sommerville, Software Engineering (8/e), Addison-Wesley, Reading, Mass, USA, 2006.
  45. B. Boehm, A. Egyed, J. Kwan, D. Port, A. Shah, and R. Madachy, “Using the WinWin spiral model: a case study,” Computer, vol. 31, no. 7, pp. 33–44, 1998. View at Google Scholar · View at Scopus
  46. Agile Alliance. Manifesto for Agile Software Development, 2001.
  47. B. Boehm and R. Turner, “Using risk to balance agile and plan-driven methods,” Computer, vol. 36, no. 6, pp. 57–66, 2003. View at Publisher · View at Google Scholar · View at Scopus
  48. B. Boehm, Turner. Balancing Agility and Discipline—A Guide for the Perplexed, Addison-Wesley, Reading, Mass, USA, 2004.
  49. S. R. Schach, Object-Oriented and Classical Software Engineering (7/e), McGraw-Hill, Boston, Mass, USA, 2006.
  50. A. Silberschatz, H. Korth, and S. Sudarshan, Database System Concepts (6/e), McGraw-Hill, Boston, Mass, USA, 2010.
  51. H. Benington , “Production of large computer programs,” in Proceedings of the Symposium on Advanced Programming Methods for Digital Computers, pp. 15–27, 1956.