%0 Journal Article %J J Digit Imaging %D 2014 %T Simplifying electronic data capture in clinical trials: workflow embedded image and biosignal file integration and analysis via web services. %A Haak, Daniel %A Samsel, Christian %A Gehlen, Johan %A Jonas, Stephan %A Deserno, Thomas M %K Algorithms %K Automatic Data Processing %K Clinical Trials as Topic %K Database Management Systems %K Humans %K Image Processing, Computer-Assisted %K Information Storage and Retrieval %K Internet %K Medical Records Systems, Computerized %K Systems Integration %K Workflow %X

To improve data quality and save cost, clinical trials are nowadays performed using electronic data capture systems (EDCS) providing electronic case report forms (eCRF) instead of paper-based CRFs. However, such EDCS are insufficiently integrated into the medical workflow and lack in interfacing with other study-related systems. In addition, most EDCS are unable to handle image and biosignal data, although electrocardiography (EGC, as example for one-dimensional (1D) data), ultrasound (2D data), or magnetic resonance imaging (3D data) have been established as surrogate endpoints in clinical trials. In this paper, an integrated workflow based on OpenClinica, one of the world's largest EDCS, is presented. Our approach consists of three components for (i) sharing of study metadata, (ii) integration of large volume data into eCRFs, and (iii) automatic image and biosignal analysis. In all components, metadata is transferred between systems using web services and JavaScript, and binary large objects (BLOBs) are sent via the secure file transfer protocol and hypertext transfer protocol. We applied the close-looped workflow in a multicenter study, where long term (7 days/24 h) Holter ECG monitoring is acquired on subjects with diabetes. Study metadata is automatically transferred into OpenClinica, the 4 GB BLOBs are seamlessly integrated into the eCRF, automatically processed, and the results of signal analysis are written back into the eCRF immediately.

%B J Digit Imaging %V 27 %P 571-80 %8 2014 Oct %G eng %N 5 %R 10.1007/s10278-014-9694-z %0 Journal Article %J J Biomed Inform %D 2011 %T A partnership approach for Electronic Data Capture in small-scale clinical trials. %A Franklin, Joshua D %A Guidry, Alicia %A Brinkley, James F %K Clinical Trials as Topic %K Data Collection %K Humans %K Internet %K Medical Informatics %X

Amid researchers' growing need for study data management, the CTSA-funded Institute for Translational Health Sciences developed an approach to combine technical and scientific resources with small-scale clinical trials researchers in order to make Electronic Data Capture more efficient. In a 2-year qualitative evaluation we found that the importance of ease of use and training materials outweighed number of features and functionality. EDC systems we evaluated were Catalyst Web Tools, OpenClinica and REDCap. We also found that two other systems, Caisis and LabKey, did not meet the specific user needs of the study group.

%B J Biomed Inform %V 44 Suppl 1 %P S103-8 %8 2011 Dec %G eng %R 10.1016/j.jbi.2011.05.008 %0 Journal Article %J Stud Health Technol Inform %D 2011 %T On selecting a clinical trial management system for large scale, multi-centre, multi-modal clinical research study. %A Leroux, Hugo %A McBride, Simon %A Gibson, Simon %K Australia %K Checklist %K Choice Behavior %K Clinical Trials as Topic %K Decision Support Systems, Clinical %K Medical Informatics %K Multicenter Studies as Topic %X

Clinical research studies offer many challenges for their supporting information systems. AIBL assembled 1112 participants who volunteered crucial information for a comprehensive study on neurodegenerative diseases. This paper discusses the shortcomings of the clinical trial management system chosen to record the results of the study. A set of guidelines was devised and a critique of five systems ensued. OpenClinica was selected as the most appropriate option. The main contribution of this paper is: (i) proposing a set of guidelines to determine the appropriateness of Clinical Trial Management Systems (CTMS) solution; (ii) providing a brief critique of existing commercial and open-sourced CTMS; and (iii) alluding to some data migration issues and providing cues on how to address them. We conclude that open-source CTMS are viable alternatives to the more expensive commercial systems to conduct, record and manage clinical studies.

%B Stud Health Technol Inform %V 168 %P 89-95 %8 2011 %G eng %0 Journal Article %J Stud Health Technol Inform %D 2010 %T Facilitating secondary use of medical data by using openEHR archetypes. %A Kohl, Christian D %A Garde, Sebastian %A Knaup, Petra %K Clinical Trials as Topic %K Feasibility Studies %K Humans %K Medical Record Linkage %K Medical Records Systems, Computerized %K Semantics %K Systems Integration %X

Clinical trials are of high importance for medical progress. But even though more and more clinical data is available in electronic patient records (EPRs) and more and more electronic data capture (EDC) systems are used in trials, there is still a gap which makes EPR / EDC interoperability difficult and hampers secondary use of medical routine data. The openEHR architecture for Electronic Health Records is based on a two level modeling approach which makes use of 'archetypes'. We want to analyze whether archetypes can help to bridge this gap by building an integrated EPR / EDC system based on openEHR archetypes. We used the 'openEHR Reference Framework and Application' (Opereffa) and existing archetypes for medical data. Furthermore, we developed dedicated archetypes to document study meta data. We developed a first prototype implementation of an archetype based integrated EPR / EDC system. Next steps will be the evaluation of an extended prototype in a real clinical trial scenario. Opereffa was a good starting point for our work. OpenEHR archetypes proved useful for secondary use of health data.

%B Stud Health Technol Inform %V 160 %P 1117-21 %8 2010 %G eng %N Pt 2