Abstract
Compliance management is a key factor for clinical trials. This paper overviews the current situation of compliance management in clinical trials. The shortcomings of the as-is situation are analyzed as well as the current scientific approaches. To overcome the deficiencies, a framework for process oriented compliance management is presented. The extraction and modeling of compliance requirements in a process oriented way is explained. In addition a matching operator is presented, showing how different compliance standards can be made comparable.
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References
Food and Drug Administration: Critical Path Opportunity Report, http://www.fda.gov/oc/initiatives/criticalpath/ (retrieving date January 10, 2011)
El Kharbili, M., Stein, S., Markovic, I., Pulvermüller, E.: Towards a Framework for Semantic Business Process Compliance Management. In: Proceedings of GRCIS (2008)
Krockenberger, K., Knaup, P., Bez, K., Gleiter, C.H.: The necessity of an electronic SOP retrieval system. Stud. Health Technol. Inform. 116, 1000–1003 (2005)
Soto, M., Münch, J.: Using Model Comparison to maintain model-to standard compliance. In: Proceedings of the 2008 Intl. Workshop on Comparison and Versioning of Software Models (2008)
ICH: Guideline for Good Clinical Practice, http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf (retrieving date January 10, 2011)
Koordinierungszentren für Klinische Studien, http://www.kks-netzwerk.de
Schnurr, B., Chase, D., Gierend, M., Rettig, S.: Qualitätssicherung in der klinischenForschung. Pharm. Ind. 66(9), 1086–1089 (2004)
Burke, J.D.: ICH-GCP & FDA Regulations Differences, http://louisville.edu/advising/humansubjects/ICH%20GCP%20-%20FDA%20Regulations%20Differences_4-20-09.ppt
Krockenberger, K., Luntz, S.P., Knaup, P.: Usage and usability of standard operating procedures (SOPs) among the coordination centers for clinical trials (KKS). Methods Inf. Med. 47(6), 505–510 (2008)
Ramos, L.: eClinical Trial Software and Vendor Landscape (2006), http://www.forrester.com/Events/Content/0,5180,-1325,00.ppt (retrieving date January 16, 2011)
Ontologies in Medicine – SOP Creator, http://www.onto-med.de/Archiv/ontomed2002/en/publicationsflyer/sopcreator.pdf (retrieving date January 19, 2011)
Limathon – SOPmanage, http://www.limathon.com/ADSL_SOP/SOPmanage_nhs_cpa.HTM (retrieving date January 19, 2011)
Schmidt, R., Bartsch, C., Oberhauser, R.: Modeling Control Objectives for Business Process Compliance, Ontology-based representation of compliance requirements for service processes. In: Proc. of Semantic Business Process and Product Lifecycle Management, SBPM (2007)
Business Rules Group: Defining business rules – what are they really, http://www.businessrulesgroup.org/first_paper/br01c0.htm (retrieving date February 3, 2011)
Simple Rule Markup Language, xml.coverpages.org/srml.html (retrieving date January 30, 2011)
Jablonski, S., Faerber, M.: Integrated Management of Company Processes and Standard Processes: A Platform to Prepare and Perform Quality Management Appraisals. In: ICSE Workshops on Software Quality, WoSQ 2007 (2007)
Jablonski, S., Faerber, M., Jochaud, F., Götz, M., Igler, M.: Enabling Flexible Execution of Business Processes. In: Meersman, R., Herrero, P. (eds.) OTM-WS 2008. LNCS, vol. 5333, pp. 10–11. Springer, Heidelberg (2008)
Jablonski, S., Bussler, C.: Workflow Management: Modeling Concepts, Architecture and Implementation. Itp New Media (1996)
Jablonski, S., Faerber, M., Kastner, N., Metzger, A.: IPM4QM – Eine integrierte Modellierung von Unternehmensprozessen und Anforderungen aus SPICE. In: Proceedings of the SQS Software & Systems Quality Conferences 2007, Düsseldorf, Germany (April 2007)
Faerber, M., Meerkamm, S., Schneider, T., Jablonski, S.: Qualitative Prozessanalyse klinischer Prozesse - Vorgehen und Erfahrungen. Arthritis + rheuma, Jahrgang, 29 (2009)
Jablonski, S., Volz, B., Rehman, M.A.: A Conceptual Modeling and Execution Framework for Process Based Scientific Applications. In: Proceedings on CyberInfrastructure: Information Management in eScience (2007)
Verner, L.: The Challenge of Process Discovery, www.bptrends.com/deliver_file.cfm?fileType=publication&fileName=05-04%20WPprocessDiscovery%20--%20Verner%201.pdf (retrieving date February 2, 2011)
Wecker, G., van Laak, H.: Compliance in der Unternehmenspraxis – Grundlagen, Organsiation und Umsetzung. Gabler (2008)
GCP-Verordnung, http://www.gesetze-im-internet.de/gcp-v/BJNR208100004.html
Faerber, M.: Prozessorientiertes Qualitätsmanagement - Ein Konzept zur Implementierung. Gabler (2010)
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Schlundt, J., Jablonski, S. (2012). Compliance Oriented Process Management Using the Example of Clinical Trials. In: Daniel, F., Barkaoui, K., Dustdar, S. (eds) Business Process Management Workshops. BPM 2011. Lecture Notes in Business Information Processing, vol 100. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-28115-0_21
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DOI: https://doi.org/10.1007/978-3-642-28115-0_21
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