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Business Rules in Clinical Trials

  • Olegas Vasilecas
  • Evaldas Lebedys
Conference paper

The paper focuses on the scope of the clinical trials. As clinical trials are rigorously controlled, it is important to have a well-designed control mechanism for clinical trials quality assurance. Each clinical trial is executed according to a set of rules. All the rules for a particular clinical trial are described in different source documents and are not stated explicitly. While rules for particular trial are not organized as a whole, it complicates the control of the trial. The need for accurate recording and processing of patient data is fundamental to any clinical trial. If data stored in the clinical trial database are incorrect, conclusions of the analyses will also inevitably be incorrect. The need of a central storage for rules in particular trial is obvious. The clinical trial business rules repository may be used to reuse the knowledge gathered in one clinical for further trials. The paper presents a method for business rules retrieval from UML models and the employment of proposed in conduct of clinical trials. The analysis of business rules approach principles application in clinical trials is presented.

Keywords

Unify Modeling Language Class Diagram Clinical Trial Design Business Rule Unify Modeling Language Model 
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.

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References

  1. 1.
    Ablett S. An introduction to clinical trials. United Kingdom Children’s Cancer Center study Group, 2004. URL: http://www.ukccsg UKCCSG Data Centre, [retrieved on 2006.04.05].
  2. 2.
    American Cancer Society. Clinical Trials: What You Need to Know, 2004. URL:http://www.cancer.org/docroot/ETO/content/ETO_6_3_ Clinical_Trials_-_Patient_Participation.asp, retrieved on 2006.04.12.
  3. 3.
    Modgil S, Hammond P, Wyatt J C, Potts V. Developing A Knowledge-based Tool for Authoring Clinical Trial Protocols. First European Work-shop on computer-based support for clinical guidance and protocols (EWGLP 2000). IOS Press, Amsterdam, Leipzig, Germany, 2000.Google Scholar
  4. 4.
    Nammunil K, Pickering C, Modgil S, Montgomery A and others. Design-a-Trial: A Rule-Based Decision Support System for Clinical Trial De-sign. Knowledge Based Systems, 17/2-4, 2000, p. 121-129.Google Scholar
  5. 5.
    Object Management Group (OMG). Unified Modeling Language (UML) Specification: Infrastructure version 2.0. URL: http://www.omg.org/docs/formal/05-07-05.pdf, retrieved on 2006.04.14.
  6. 6.
    Shen W, Compton K, Huggins J K. A Toolset for Supporting UML Static and Dynamic Model Checking. In proceedings of the 26th International Computer Software and Applications Conference (COMPSAC 2002), Prolonging Software Life: Development and Redevelopment, Oxford, England, IEEE Computer Society, 2002: p. 147-152.Google Scholar
  7. 7.
    U.S. Department of Health and Human Services, Food and Drug Admini-stration. Guidance for Industry. Computerised systems used in Clinical Trials. Draft guidance, 2004. URL: http://www.fda.gov/Cder/guidance/6032dft.htm, retrieved on 2006.04.17.
  8. 8.
    U.S. Department of Health and Human Services, Food and Drug Admini-stration. Guidance for Industry. E6 Good Clinical Practice: Consolidated Guidance, 1996. URL: http://www.va.gov/chrr/regulatory/vrb/files_forms/ GoodClinicalPractices.pdf, retrieved on 2006.03.11.
  9. 9.
    Vasilecas O, Lebedys E, Laucius J. Formal methods for representation of business rules specified using UML. // In: R. Simutis (eds.). Proceedings of the International Conference “Information Technologies for business -2005”, Kaunas: Technologija, p. 41-47, 2005.Google Scholar
  10. 10.
    Vasilecas O, Lebedys E. Business rules repository for business rules rep-resented using UML // In R. Rachev, A. Smrikarov (Eds.). Proc. of the International Conference on Computer Systems and Technologies “CompSysTech‚ 05 ”, Varna, Bulgaria, 16-17 June. 2004, p. II.5-1 - II.5-6.Google Scholar
  11. 11.
    Vasilecas O, Lebedys E. Repository for Business Rules Represented in UML Diagrams // Izvestia of the Belarusian Engineering Academy, 2005, Vol. 1 (19)/2, p. 187-192.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Olegas Vasilecas
    • 1
  • Evaldas Lebedys
    • 1
  1. 1.Department of Information SystemsVilnius Gediminas Technical UniversityLithuania

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