<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1684-1859</journal-id>
<journal-title><![CDATA[Revista Cubana de Informática Médica]]></journal-title>
<abbrev-journal-title><![CDATA[RCIM]]></abbrev-journal-title>
<issn>1684-1859</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Ciencias Médicas de La Habana]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1684-18592021000100005</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC]]></article-title>
<article-title xml:lang="en"><![CDATA[Clinical Trials Data Management System XAVIA SIDEC]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vega Izaguirre]]></surname>
<given-names><![CDATA[Leodan]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Quintana Díaz]]></surname>
<given-names><![CDATA[Victor Manuel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Tamayo Peña]]></surname>
<given-names><![CDATA[Rafael]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Dominguez Izquierdo]]></surname>
<given-names><![CDATA[Yackelyn Dayanys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Molina Hernández]]></surname>
<given-names><![CDATA[Yenisel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de las Ciencias Informáticas Centro de Informática Médica ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2021</year>
</pub-date>
<volume>13</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1684-18592021000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1684-18592021000100005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1684-18592021000100005&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El ensayo clínico constituye el método empleado para evaluar un producto, sustancia, medicamento, técnica diagnóstica o terapéutica. La industria biotecnológica emplea sistemas de gestión de ensayos clínicos para lograr un manejo eficiente de los datos recopilados durante el proceso. El Centro de Inmunología Molecular (CIM) emplea el Sistema de Gestión de Ensayos Clínicos XAVIA Clínicas desarrollado por la UCI, para soportar el 100% de los ensayos clínicos desde el 2012. XAVIA Clínicas posee limitantes en sus funcionalidades; además, a partir de la experiencia obtenida por su uso, se identificaron mejoras y nuevas funcionalidades que constituyen el incentivo para desarrollar un nuevo sistema. El objetivo del presente artículo es presentar el Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC y su generalización en las instituciones de BioCubaFarma. Se estudió la bibliografía referente al manejo de datos de ensayos clínicos y cuadernos de recogida de datos electrónicos y se analizaron sistemas homólogos disponibles en el mercado internacional. La metodología de desarrollo empleada fue AUP-UCI. Se utilizó Eclipse como entorno integrado de desarrollo, Java como lenguaje de programación, JBoss como servidor de aplicaciones y PostgreSQL como sistema de gestión de bases de datos. El Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC facilita y flexibiliza el diseño y aprobación de los Cuadernos de recogida de información (CRD), estandariza la información manejada, valida los datos recopilados a través de reglas, mejora el flujo de información entre las entidades que conducen el ensayo y optimiza el proceso de monitoreo.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Clinical trial is the method used to evaluate a product, substance, medicine, diagnostic or therapeutic technique. The biotechnology industry employs clinical trial management systems to achieve efficient management of data collected during clinical trials. CIM (Centro de Inmunología Molecular) uses the Clinical Trials Management System XAVIA Clínicas developed by UCI, to support 100% of clinical trials since 2012. This system has limitations in its functionalities; furthermore, based on the experience obtained, improvements and new functionalities were identified, so it was decided to develop a new version of the system. The objective of this article is to present the Clinical Trials Data Management System XAVIA SIDEC and its generalization in BioCubaFarma institutions. The bibliography referring to the clinical trial data management and electronic data collection notebooks was studied and homologous systems available in the international market were analyzed. The development methodology used was AUP-UCI. Eclipse was used as an integrated development environment, Java as a programming language, JBoss as an application server and PostgreSQL as a database management system. The Clinical Trials Data Management System XAVIA SIDEC facilitates and makes the Case Report Forms (CRF) design and approval more flexible, standardizes the information handled, validates the data collected through rules, improves the flow of information between the entities conducting the trial and optimizes the monitoring process.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[sistemas de gestión de ensayos clínicos;, cuadernos de recogida de datos electrónicos]]></kwd>
<kwd lng="es"><![CDATA[XAVIA SIDEC]]></kwd>
<kwd lng="en"><![CDATA[clinical trials management system]]></kwd>
<kwd lng="en"><![CDATA[electronic clinical form record]]></kwd>
<kwd lng="en"><![CDATA[XAVIA SIDEC]]></kwd>
</kwd-group>
</article-meta>
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