SPEM 2.0 extension for pervasive information systems

Pervasive computing is a research field of computing technology that aims to achieve a new computing paradigm. In this paradigm, the physical environment has a high degree of pervasiveness and availability of computers and other information technology (IT) devices, usually with communication capabilities. Pervasive Information Systems (PIS), composed by these kinds of devices, bring issues that challenge software development for them. Model-Driven Development (MDD), strongly focusing and relying on models, has the potential to allow: the use of concepts closer to the domain and the reduction of semantic gaps; higher automation and lower dependency to technological changes; higher capture of expert knowledge and reuse; an overall increased productivity. Along with the focus and use of models, software development processes are fundamental to efficient development efforts of successful software systems. For the description of processes, Software & Systems Process Engineering Meta-Model Specification (SPEM) is the current standard specification published by the Object Management Group (OMG). This paper presents an extension to SPEM (version 2.0) Base Plug-In Profile that includes stereotypes needed to support a suitable structural process organization for MDD approaches aiming to develop software for PIS. A case study is provided to evaluate the applicability of the extension

A Model-Based Approach to Comprehensive Risk Management for Medical Devices

The European medical technology industry consists of around 27,000 companies, more than 95% of them small and medium-sized enterprises (SMEs), with over 675,000 employees [MEDT17]. In the European Union (EU) alone, medical devices constituted by far the biggest part of the medical technology (MedTech) sector with a market of 95 billion euros in annual sales in 2015 [EURO15].The European medical technology industry consists of around 27,000 companies, more than 95% of them small and medium-sized enterprises (SMEs), with over 675,000 employees [MEDT17]. In the European Union (EU) alone, medical devices constituted by far the biggest part of the medical technology (MedTech) sector with a market of 95 billion euros in annual sales in 2015 [EURO15]

A Model-Driven Approach for the Design, Implementation, and Execution of Software Development Methods

[EN] Software development projects are diverse in nature. For this reason, software companies are often forced to define their methods in-house. In order to define methods efficiently and effectively, software companies require systematic solutions that are built upon sound methodical foundations. Providing these solutions is the main goal of the Method Engineering discipline. Method Engineering is the discipline to design, construct, and adapt methods, techniques, and tools for the development of information systems. Over the last two decades, a lot of research work has been performed in this area. However, despite its potential benefits, Method Engineering is not widely used in industrial settings. Some of the causes of this reality are the high theoretical complexity of Method Engineering and the lack of adequate software support. In this thesis, we aim to mitigate some of the problems that affect Method Engineering by providing a novel methodological approach that is built upon Model-Driven Engineering (MDE) foundations. The use of MDE enables a rise in abstraction, automation, and reuse that allows us to alleviate the complexity of our Method Engineering approach. Furthermore, by leveraging MDE techniques (such as metamodeling, model transformations, and models at runtime), our approach supports three phases of the Method Engineering lifecycle: design, implementation, and execution. This is unlike traditional Method Engineering approaches, which, in general, only support one of these phases. In order to provide software support for our proposal, we developed a Computer-Aided Method Engineering (CAME) environment that is called MOSKitt4ME. To ensure that MOSKitt4ME offered the necessary functionality, we identified a set of functional requirements prior to developing the tool. Then, after these requirements were identified, we defined the architecture of our CAME environment, and, finally, we implemented the architecture in the context of Eclipse. The thesis work was evaluated by means of a study that involved the participation of end users. In this study, MOSKitt4ME was assessed by means of the Technology Acceptance Model (TAM) and the Think Aloud method. While the TAM allowed us to measure usefulness and ease of use in a subjective manner, the Think Aloud method allowed us to analyze these measures objectively. Overall, the results were favorable. MOSKitt4ME was highly rated in perceived usefulness and ease of use; we also obtained positive results with respect to the users' actual performance and the difficulty experienced.[ES] Los proyectos de desarrollo de software son diversos por naturaleza. Por este motivo, las compañías de software se ven forzadas frecuentemente a definir sus métodos de manera interna. Para poder definir métodos de forma efectiva y eficiente, las compañías necesitan soluciones sistemáticas que estén definidas sobre unos fundamentos metodológicos sólidos. Proporcionar estas soluciones es el principal objetivo de la Ingeniería de Métodos. La Ingeniería de Métodos es la disciplina que aborda el diseño, la construcción y la adaptación de métodos, técnicas y herramientas para el desarrollo de sistemas de información. Durante las dos últimas décadas, se ha llevado a cabo mucho trabajo de investigación en esta área. Sin embargo, pese a sus potenciales beneficios, la Ingeniería de Métodos no se aplica ampliamente en contextos industriales. Algunas de las principales causas de esta situación son la alta complejidad teórica de la Ingeniería de Métodos y la falta de un apropiado soporte software. En esta tesis, pretendemos mitigar algunos de los problemas que afectan a la Ingeniería de Métodos proporcionando una propuesta metodológica innovadora que está basada en la Ingeniería Dirigida por Modelos (MDE). El uso de MDE permite elevar el nivel de abstracción, automatización y reuso, lo que posibilita una reducción de la complejidad de nuestra propuesta. Además, aprovechando técnicas de MDE (como por ejemplo el metamodelado, las transformaciones de modelos y los modelos en tiempo de ejecución), nuestra aproximación da soporte a tres fases del ciclo de vida de la Ingeniería de Métodos: diseño, implementación y ejecución. Esto es a diferencia de las propuestas existentes, las cuales, por lo general, sólo dan soporte a una de estas fases. Con el objetivo de proporcionar soporte software para nuestra propuesta, implementamos una herramienta CAME (Computer-Aided Method Engineering) llamada MOSKitt4ME. Para garantizar que MOSKitt4ME proporcionaba la funcionalidad necesaria, definimos un conjunto de requisitos funcionales como paso previo al desarrollo de la herramienta. Tras la definción de estos requisitos, definimos la arquitectura de la herramienta CAME y, finalmente, implementamos la arquitectura en el contexto de Eclipse. El trabajo desarrollado en esta tesis se evaluó por medio de un estudio donde participaron usuarios finales. En este estudio, MOSKitt4ME se evaluó por medio del Technology Acceptance Model (TAM) y del método Think Aloud. Mientras que el TAM permitió medir utilidad y facilidad de uso de forma subjetiva, el método Think Aloud permitió analizar estas medidas objetivamente. En general, los resultados obtenidos fueron favorables. MOSKitt4ME fue valorado de forma positiva en cuanto a utilidad y facilidad de uso percibida; además, obtuvimos resultados positivos en cuanto al rendimiento objetivo de los usuarios y la dificultad experimentada.[CA] Els projectes de desenvolupament de programari són diversos per naturalesa. Per aquest motiu, les companyies es veuen forçades freqüenment a definir els seus mètodes de manera interna. Per poder definir mètodes de forma efectiva i eficient, les companyies necessiten solucions sistemàtiques que estiguin definides sobre uns fundaments metodològics sòlids. Proporcionar aquestes solucions és el principal objectiu de l'Enginyeria de Mètodes. L'Enginyeria de Mètodes és la disciplina que aborda el diseny, la construcció i l'adaptació de mètodes, tècniques i eines per al desenvolupament de sistemes d'informació. Durant les dues últimes dècades, s'ha dut a terme molt de treball de recerca en aquesta àrea. No obstant, malgrat els seus potencials beneficis, l'Enginyeria de Mètodes no s'aplica àmpliament en contextes industrials. Algunes de les principals causes d'aquesta situació són l'alta complexitat teòrica de l'Enginyeria de Mètodes i la falta d'un apropiat suport de programari. En aquesta tesi, pretenem mitigar alguns dels problemes que afecten a l'Enginyeria de Mètodes proporcionant una proposta metodològica innovadora que està basada en l'Enginyeria Dirigida per Models (MDE). L'ús de MDE ens permet elevar el nivell d'abstracció, automatització i reutilització, possibilitant una reducció de la complexitat de la nostra proposta. A més a més, aprofitant tècniques de MDE (com per exemple el metamodelat, les transformacions de models i els models en temps d'execució), la nostra aproximació suporta tres fases del cicle de vida de l'Enginyeria de Mètodes: diseny, implementació i execució. Açò és a diferència de les propostes existents, les quals, en general, només suporten una d'aquestes fases. Amb l'objectiu de proporcionar suport de programari per a la nostra proposta, implementàrem una eina CAME (Computer-Aided Method Engineering) anomenada MOSKitt4ME. Per garantir que MOSKitt4ME oferia la funcionalitat necessària, definírem un conjunt de requisits funcionals com a pas previ al desenvolupament de l'eina. Després de la definició d'aquests requisits, definírem la arquitectura de l'eina CAME i, finalment, implementàrem l'arquitectura en el contexte d'Eclipse. El treball desenvolupat en aquesta tesi es va avaluar per mitjà d'un estudi on van participar usuaris finals. En aquest estudi, MOSKitt4ME es va avaluar per mitjà del Technology Acceptance Model (TAM) i el mètode Think Aloud. Mentre que el TAM va permetre mesurar utilitat i facilitat d'ús de manera subjectiva, el mètode Think Aloud va permetre analitzar aquestes mesures objectivament. En general, els resultats obtinguts van ser favorables. MOSKitt4ME va ser valorat de forma positiva pel que fa a utilitat i facilitat d'ús percebuda; a més a més, vam obtenir resultats positius pel que fa al rendiment objectiu dels usuaris i a la dificultat experimentada.Cervera Úbeda, M. (2015). A Model-Driven Approach for the Design, Implementation, and Execution of Software Development Methods [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/53931TESI

MODEL DRIVEN SOFTWARE PRODUCT LINE ENGINEERING: SYSTEM VARIABILITY VIEW AND PROCESS IMPLICATIONS

La Ingeniería de Líneas de Productos Software -Software Product Line Engineerings (SPLEs) en inglés- es una técnica de desarrollo de software que busca aplicar los principios de la fabricación industrial para la obtención de aplicaciones informáticas: esto es, una Línea de productos Software -Software Product Line (SPL)- se emplea para producir una familia de productos con características comunes, cuyos miembros, sin embargo, pueden tener características diferenciales. Identificar a priori estas características comunes y diferenciales permite maximizar la reutilización, reduciendo el tiempo y el coste del desarrollo. Describir estas relaciones con la suficiente expresividad se vuelve un aspecto fundamental para conseguir el éxito. La Ingeniería Dirigida por Modelos -Model Driven Engineering (MDE) en inglés- se ha revelado en los últimos años como un paradigma que permite tratar con artefactos software con un alto nivel de abstracción de forma efectiva. Gracias a ello, las SPLs puede aprovecharse en granmedida de los estándares y herramientas que han surgido dentro de la comunidad de MDE. No obstante, aún no se ha conseguido una buena integración entre SPLE y MDE, y como consecuencia, los mecanismos para la gestión de la variabilidad no son suficientemente expresivos. De esta manera, no es posible integrar la variabilidad de forma eficiente en procesos complejos de desarrollo de software donde las diferentes vistas de un sistema, las transformaciones de modelos y la generación de código juegan un papel fundamental. Esta tesis presenta MULTIPLE, un marco de trabajo y una herramienta que persiguen integrar de forma precisa y eficiente los mecanismos de gestión de variabilidad propios de las SPLs dentro de los procesos de MDE. MULTIPLE proporciona lenguajes específicos de dominio para especificar diferentes vistas de los sistemas software. Entre ellas se hace especial hincapié en la vista de variabilidad ya que es determinante para la especificación de SPLs.Gómez Llana, A. (2012). MODEL DRIVEN SOFTWARE PRODUCT LINE ENGINEERING: SYSTEM VARIABILITY VIEW AND PROCESS IMPLICATIONS [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/15075Palanci

Engaging end-user driven recommender systems: personalization through web augmentation

In the past decades recommender systems have become a powerful tool to improve personalization on the Web. Yet, many popular websites lack such functionality, its implementation usually requires certain technical skills, and, above all, its introduction is beyond the scope and control of end-users. To alleviate these problems, this paper presents a novel tool to empower end-users without programming skills, without any involvement of website providers, to embed personalized recommendations of items into arbitrary websites on client-side. For this we have developed a generic meta-model to capture recommender system configuration parameters in general as well as in a web augmentation context. Thereupon, we have implemented a wizard in the form of an easy-to-use browser plug-in, allowing the generation of so-called user scripts, which are executed in the browser to engage collaborative filtering functionality from a provided external rest service. We discuss functionality and limitations of the approach, and in a study with end-users we assess the usability and show its suitability for combining recommender systems with web augmentation techniques, aiming to empower end-users to implement controllable recommender applications for a more personalized browsing experience.Fil: Wischenbart, Martin. Johannes Kepler University Linz; AustriaFil: Firmenich, Sergio Damian. Universidad Nacional de La Plata. Facultad de Informática. Laboratorio de Investigación y Formación en Informática Avanzada; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; ArgentinaFil: Rossi, Gustavo Héctor. Universidad Nacional de La Plata. Facultad de Informática; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; ArgentinaFil: Bosetti, Gabriela Alejandra. Universidad Nacional de La Plata. Facultad de Informática; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; ArgentinaFil: Kapsammer, Elisabeth. Johannes Kepler University Linz; Austri

Quality Assurance of Software Models - A Structured Quality Assurance Process Supported by a Flexible Tool Environment in the Eclipse Modeling Project

The paradigm of model-based software development (MBSD) has become more and more popular since it promises an increase in the efficiency and quality of software development. In this paradigm, software models play an increasingly important role and software quality and quality assurance consequently leads back to the quality and quality assurance of the involved models. The fundamental aim of this thesis is the definition of a structured syntax-oriented process for quality assurance of software models that can be adapted to project-specific and domain-specific needs. It is structured into two sub-processes: a process for the specification of project-specific model quality assurance techniques, and a process for applying them on concrete software models within a MBSD project. The approach concentrates on quality aspects to be checked on the abstract model syntax and is based on quality assurance techniques model metrics, smells, and refactorings well-known from literature. So far, these techniques are mostly considered in isolation only and therefore the proposed process integrates them in order to perform model quality assurance more systematically. Three example cases performing the process serve as proof-of-concept implementations and show its applicability, its flexibility, and hence its usefulness. Related to several issues concerning model quality assurance minor contributions of this thesis are (1) the definition of a quality model for model quality that consists of high-level quality attributes and low-level characteristics, (2) overviews on metrics, smells, and refactorings for UML class models including structured descriptions of each technique, and (3) an approach for composite model refactoring that concentrates on the specification of refactoring composition. Since manually reviewing models is time consuming and error prone, several tasks of the proposed process should consequently be automated. As a further main contribution, this thesis presents a flexible tool environment for model quality assurance which is based on the Eclipse Modeling Framework (EMF), a common open source technology in model-based software development. The tool set is part of the Eclipse Modeling Project (EMP) and belongs to the Eclipse incubation project EMF Refactor which is available under the Eclipse public license (EPL). The EMF Refactor framework supports both the model designer and the model reviewer by obtaining metrics reports, by checking for potential model deficiencies (called model smells) and by systematically restructuring models using refactorings. The functionality of EMF Refactor is integrated into standard tree-based EMF instance editors, graphical GMF-based editors as used by Papyrus UML, and textual editors provided by Xtext. Several experiments and studies show the suitability of the tools for supporting the techniques of the structured syntax-oriented model quality assurance process

Achieving non-intrusive interoperability between models for involving users in modeling tasks

[EN] Model-Driven Development (MDD) promotes models as the cornerstone in the software development process, thereby displacing source code as the development process's main feature. Although this model-centric schema claims advantages over traditional software development (e.g., the code could be automatically generated from the models), it does not have the level of adoption that has been expected. The literature review reveals a broad agreement in the fact that end-users may develop and adapt systems themselves but the complexity in modeling standards and the lack of modeling skills prevents their active involvement in modeling tasks of existing MDD processes. To overcome this, end-users should be provided with different modeling languages that use concepts, which fit their particular skills, context and needs. This challenge is the main goal of this thesis, which is addressed by combining the End-user Development and the Model-Driven Development fields. This work starts with the involvement of end-users into the modeling tasks using a tool-supported visual modeling language that allows end-users to select and customize system features of pervasive systems using closer concepts for them. Afterwards, this thesis shows the necessity of enriching existing MDD processes for supporting the development of a new generation of software systems (e.g., smart health) that require expertise in a variety of domains. Consequently, different types of users (e.g., scientists, engineers and end-users) must actively participate in the description of model fragments that depend on their expertise using a different modeling language. Thus, users are able to collaborate to obtain a unified system description. At this point, it becomes necessary to provide mechanisms that transforms models fragments from one modeling language to another, delimits which model fragments are described by a different user, and integrates those model fragments. To provide this, the presented approach encompasses variability management in a novel way to enable collaborative modeling by supporting both the selection of model fragments of the system that may be described using a different modeling language, and the integration of those model fragments once they are described. Furthermore, interoperability mechanisms bridge two different modeling languages in a non-intrusive way with the structure of models by transforming the description of gaps. Thus, our proposal could enrich models of existing MDD processes with model fragments that have been described using a different modeling language, which could make users feel confident to adopt models for describing domain-specific content and could help to adopt MDD processes. The proposal has been validated in three case studies from different levels of complexity and domains: smart home systems, web information systems, and biomechanical protocols. The results have proven the applicability and feasibility of our approach to actively involve different types of users (end- users with software professionals, domain experts with software development experts, and doctors with biomedical engineers, respectively) in model descriptions of existing MDD processes using a different modeling language.[ES] En el Desarrollo de Software Dirigido por Modelos (DSDM) los modelos son la piedra angular del proceso de desarrollo de software, desplazando así al código fuente como artefacto principal. Aunque este enfoque centrado en modelos ofrece ventajas sobre el desarrollo de software tradicional (por ejemplo, la generación de código de forma automática a partir de los modelos) no tiene el nivel de adopción esperado. La literatura científica revela un amplio acuerdo en el hecho de que los usuarios finales puedan ellos mismos desarrollar y adaptar los sistemas pero la complejidad de los estándares de modelado y la carencia de habilidades de modelado impide su participación activa en procesos DSDM existentes. Para lograrlo, los usuarios finales deben disponer de lenguajes de modelado diferentes con conceptos adaptados a sus habilidades, contexto y necesidades. Este desafío es el objetivo principal de esta tesis que se aborda combinando las ideas del desarrollo orientado al usuario final y el DSDM. Este trabajo comienza involucrando usuarios finales en tareas de modelado con una herramienta que les proporciona un lenguaje de modelado visual para seleccionar y personalizar características de un sistema pervasivo utilizando conceptos familiares para ellos. Después, esta tesis motiva la necesidad de enriquecer procesos de DSDM existentes para soportar el desarrollo de una nueva generación de sistemas software (por ejemplo, salud inteligente) que requieren conocimientos especializados en una variedad de dominios. Consecuentemente, diferentes tipos de usuarios (por ejemplo, científicos, ingenieros y usuarios finales) deben participar activamente en la descripción de fragmentos de modelos que dependen de su experiencia utilizando un lenguaje de modelado diferente. De este modo, los usuarios pueden colaborar para obtener una descripción del sistema unificada. En este punto, es necesario proporcionar mecanismos que transformen e integren los fragmentos de un lenguaje de modelado a otro y delimiten qué fragmentos se describen por un usuario diferente. Para proporcionar esto, la propuesta presentada utiliza la gestión de variabilidad de forma novedosa para permitir modelado colaborativo seleccionando fragmentos de un modelo del sistema que pueden ser descritos utilizando un lenguaje de modelado diferente y, la integración de esos fragmentos una vez que hayan sido descritos. Además, la propuesta utiliza mecanismos de interoperabilidad para conectar dos lenguajes de modelado diferentes transformando la descripción de los fragmentos de una manera no invasiva con su estructura. Por tanto, nuestra propuesta puede enriquecer los modelos de procesos DSDM existentes con fragmentos de modelos que han sido descritos con un lenguaje diferente y esto, podría hacer que los usuarios se sientan seguros al adoptar modelos para describir contenido de dominio específico y podría ayudar a adoptar procesos DSDM. La propuesta ha sido validada en tres casos de estudio con diferentes niveles de complejidad y dominios: sistemas para el hogar inteligente, sistemas de información web y protocolos biomecánicos. Los resultados han demostrado la aplicabilidad y viabilidad de nuestra propuesta para involucrar diferentes tipos de usuarios (usuarios finales con profesionales de software, expertos en el dominio con expertos en desarrollo de software y, médicos con ingenieros biomédicos, respectivamente) en descripciones de modelos de procesos DSDM existentes utilizando un lenguaje de modelado diferente.[CA] En el Desenvolupament de Programari Dirigit per Models (DPDM) els models són la pedra angular del procés de desenvolupament de programari, desplaçant així al codi font com a artefacte principal. Encara que aquest enfocament centrat en models ofereix avantatges sobre el desenvolupament de programari tradicional (per exemple, la generació de codi de forma automàtica a partir dels models) no té el nivell d'adopció esperat. La literatura científica revela un ampli acord en el fet que els usuaris finals puguen ells mateixos desenvolupar i adaptar els sistemes però la complexitat dels estàndards de modelatge i la falta d'habilitats de modelatge impedeix la seua participació activa en processos DPDM existents. Per a aconseguir-ho, els usuaris finals han de disposar de llenguatges de modelatge diferents amb conceptes adaptats a les seues habilitats, context i necessitats. Aquest desafiament és l'objectiu principal d'aquesta tesi que s'aborda combinant les idees del desenvolupament orientat a l'usuari final i el DPDM. Aquest treball comença involucrant usuaris finals en tasques de modelatge amb una eina que els proporciona un llenguatge de modelatge visual que permet als usuaris finals seleccionar i personalitzar característiques d'un sistema pervasiu utilitzant conceptes familiars per a ells. Després, aquesta tesi motiva la necessitat d'enriquir processos de DPDM existents per a suportar el desenvolupament d'una nova generació de sistemes programari (per exemple, salut intel¿ligent) que requereixen coneixements especialitzats en una varietat de dominis. Conseqüentment, diferents tipus d'usuaris (per exemple, científics, enginyers i usuaris finals) han de participar activament en la descripció de fragments de models que depenen de la seua experiència utilitzant un llenguatge de modelatge diferent. D'aquesta manera, els usuaris poden col¿laborar per a obtenir una descripció del sistema unificada. En aquest punt, és necessari proporcionar mecanismes que transformen i integren els fragments d'un llenguatge de modelatge a un altre i delimiten quins fragments es descriuen per un usuari diferent. Per a proporcionar açò, la proposta presentada utilitza la gestió de variabilitat de forma nova per a permetre modelatge col.laboratiu seleccionant fragments d'un model del sistema que poden ser descrits utilitzant un llenguatge de modelatge diferent i, la integració d'aqueixos fragments una vegada que hagen sigut descrits. A més, la proposta utilitza mecanismes d'interoperabilitat per a connectar dos llenguatges de modelatge diferents transformant la descripció dels fragments d'una manera no invasiva amb la seua estructura. Per tant, la nostra proposta pot enriquir els models de processos DPDM existents amb fragments de models que han sigut descrits amb un llenguatge diferent i açò, podria fer que els usuaris se senten segurs en adoptar models per a descriure contingut de domini específic i podria ajudar a adoptar processos DPDM. La proposta ha sigut validada en tres casos d'estudi amb diferents nivells de complexitat i dominis: sistemes per a la llar intel¿ligent, sistemes d'informació web i protocols biomecànics. Els resultats han demostrat l'aplicabilitat i viabilitat de la nostra proposta per a involucrar diferents tipus d'usuaris (usuaris finals amb professionals de programari, experts en el domini amb experts en desenvolupament de programari i, metges amb enginyers biomèdics, respectivament) en descripcions de models de processos DPDM existents utilitzant un llenguatge de modelatge diferent.Pérez Pérez, MF. (2015). Achieving non-intrusive interoperability between models for involving users in modeling tasks [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/58429TESI

A pattern-oriented and model-driven architecture for interactive systems

Day-to-day experiences suggest that it is not enough to approach a complex design equipped with design tips, guidelines, and hints. Developers must also be able to use proven solutions emerging from the best design practices to solve new design challenges. Without these, the designer is unable to properly apply guidelines or take full advantage of the power of technology, resulting therefore in poor performance, poor scalability, and poor usability. Furthermore, the designer might "reinvent the wheel" when attempting to implement a design solution. A number of design problems continue to arise, such as: (1) decoupling the various aspects of interactive systems (for example, business logic, the UI, navigation, and information architecture) and (2) isolating platform specifics from the concerns common to all interactive systems. In the context of a proposal for a Pattern-Oriented and Model-driven Architecture (POMA) for interactive systems, this thesis identifies an extensive list of pattern categories and types of models aimed at providing a pool of proven solutions to these problems. The models of patterns span several levels of abstraction, such as domain, task, dialog, presentation and layout. The proposed POMA architecture illustrates how several individual models can be combined at different levels of abstraction into heterogeneous structures which can then be used as building blocks in the development of interactive systems. This document is divided into six chapters: the first chapter presents a background and related work on "Patterns" in general and on various architectures for interactive systems development such as "N-tiers architectures", "Pattern-Oriented Design" (POD), "Pattern- Supported Approach" (PSA), and "Model-Driven Architecture" (MDA). The second chapter introduces the research topic with its objectives, its limits, the research methodology, and research steps. The third chapter describes primarily the most important parts of the research which is the development of a new architecture called Pattern-Oriented and Model-Driven Architecture, facilitating the development of interactive systems including fundamentals and key concepts, an overview, justifications versus N-tiers, POD, PSA, and MDA architectures and specifications. The fourth chapter describes architectural levels and categories of patterns used in POMA. The fifth chapter describes the categories of models used in POMA. The sixth chapter presents an exploratory case study applied to the architecture proposed in this research. The last chapter presents a conclusion on this research work and its expected evolution in the future

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

AbstractEfficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard