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Design and Development of a Web-Based Clinical Trial Management System

Submitted by holger on Sun, 2017/11/05 - 06:57
TitleDesign and Development of a Web-Based Clinical Trial Management System
Publication TypeThesis
Year of Publication2014
AuthorsKrenn, R
Academic DepartmentInstitute of Information Systems and Computer Media
Date Published05/2014
UniversityGraz University of Technology

Clinical trials represent a compulsory and labour-intensive part in the course of the approval process of new diagnostic or therapeutic measures. Trials are conducted by specialized staff at trial sites such as the Clinical Research Center (CRC), a dedicated facility for Phase I and II clinical trials of the Medical University of Graz. Clinical Trial Management System (CTMS) is a term for enterprise applications, which map the particular processes of trial sites. This work introduces the Phoenix CTMS, a tailored Java web application of medium size, which covers all major processes at the CRC. Its mutli-tiered architecture is based on a Spring/Hibernate/JSF technology stack. While a model-driven approach is used for backend layers, generated artefacts are avoided for the extensive Rich Internet Application (RIA) presentation layer, which utilizes a state-of-the-art JSF component suite. Elaborated user requirements are implemented in multiple modules and range from group-ware features such as web calendars, document management and creation up to complete Electronic Data Capture (EDC) capabilities with input form composition and scripting plus editors for ad-hoc queries, allowing to formulate subject eligibility criteria. Compliance with relevant regulations (Good Clinical Practice, Data Privacy Act) is considered by an exceptional number of data security measures, including: subject de-identification and application-level encryption of data at rest, audit trail and digital signatures, configurable user privileges and host-based access restriction. It is shown how this business-critical application was designed, implemeted and rolled out at the level of commercial software products, while keeping costs minimal. The Phoenix CTMS is realeased under LGPLv2.1,, ISBN 978-3-200-04054-0.

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