An Information System to Support and Monitor Clinical Trial Process

The demand of transparency of clinical research results, the need of accelerating the process of transferring innovation in the daily medical practice as well as assuring patient safety and product efficacy make it necessary to extend the functionality of traditional trial registries. These new systems should combine different functionalities to track the information exchange, support collaborative work, manage regulatory documents and monitor the en tire clinical investigation (CIV) lifecycle. This is the approach used to develop MEDIS, a Medical Device Information System, described in this paper under the perspective of the business process, and the underlining architecture. Moreover, MEDIS was designed on the basis of Health Level 7 (HL7) v.3 standards and methodologyto make it interoperable with similar registries, but also to facilitate information exchange between different health information systems.

[1]  Valerie Durkalski,et al.  A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression , 2010, Clinical trials.

[2]  I. Sim.  Trial Registration for Public Trust: Making the Case for Medical Devices , 2007, Journal of general internal medicine.

[3]  Nicholas C. Ide,et al.  Issues in the registration of clinical trials. , 2007, JAMA.

[4]  I. Sim,et al.  Compliance of clinical trial registries with the World Health Organization minimum data set: a survey , 2009, Trials.

[5]  Ana Marusic,et al.  Clinical trial registration: looking back and moving ahead , 2007, The Lancet.

[6]  C Ohmann,et al.  Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research , 2009, Methods of Information in Medicine.

[7]  Daniela Luzi,et al.  The HL7 RIM in the Design and Implementation of an Information System for Clinical Investigations on Medical Devices , 2010, E-HEALTH.

[8]  Gregory Campbell.  Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals , 2008, Journal of biopharmaceutical statistics.

[9]  R. Simes.  Publication bias: the case for an international registry of clinical trials. , 1986, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[10]  A Gouveia Oliveira,et al.  Design Aspects of a Distributed Clinical Trials Information System on Behalf Of: the Society for Clinical Trials Data Management and Study Conduct Design Aspects of a Distributed Clinical Trials Information System , 2006 .

[11]  H. Prokosch,et al.  Perspectives for Medical Informatics , 2009, Methods of Information in Medicine.

[12]  G Rennels,et al.  A trial bank model for the publication of clinical trials. , 1995, Proceedings. Symposium on Computer Applications in Medical Care.

[13]  I. Leviton,et al.  Registering clinical trials. , 2003, Journal of the American Medical Association (JAMA).

[14]  Alexa T. McCray,et al.  Application of Technology: Design and Implementation of a National Clinical Trials Registry , 2000, J. Am. Medical Informatics Assoc..

[15]  Julie Evans,et al.  Model Formulation: The BRIDG Project: A Technical Report , 2008, J. Am. Medical Informatics Assoc..

[16]  Alexa T. McCray,et al.  Design, Implementation and Management of a Web-Based Data Entry System for ClinicalTrials.gov , 2004, MedInfo.

[17]  Martin J. O'Connor,et al.  Towards Semantic Interoperability in a Clinical Trials Management System , 2006, International Semantic Web Conference.

[18]  Fabrizio L. Ricci,et al.  A Medical Device Domain Analysis Model Based on HL7 RIM , 2009, MIE.

[19]  An outline for public registration of clinical trials evaluating medical devices. , 2006, Journal of the American College of Cardiology.

[20]  Daniela Luzi,et al.  Serious Adverse Event Reporting in a Medical Device Information System , 2011, MIE.

[21]  David W. McDonald,et al.  The multiple views of inter-organizational authoring , 2004, CSCW.

[22]  Gottfried Vossen,et al.  Single Source Information Systems to Connect Patient Care and Clinical Research , 2009, MIE.

[23]  Charles N. Mead,et al.  The HL7 Reference Information Model Under Scrutiny , 2006, MIE.

[24]  K. Krleza-Jeric.  Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group , 2005, PLoS medicine.

[25]  K. Huemer,et al.  Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN) , 2009, Trials.