Compliance Oriented Process Management Using the Example of Clinical Trials

被引:0
|
作者
Schlundt, Joerg [1 ]
Jablonski, Stefan [2 ]
机构
[1] PRODATO Integrat Technol GmbH, Hauptstr 40, D-91054 Erlangen, Germany
[2] Univ Bayreuth, Chair Databases & Informat Syst, D-95447 Bayreuth, Germany
关键词
Compliance management; Standard Operating Procedures; Process Modeling; Clinical Trials;
D O I
暂无
中图分类号
TP [自动化技术、计算机技术];
学科分类号
0812 ;
摘要
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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页码:212 / +
页数:3
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