<?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>S1684-18592020000200013</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Biblioteca para el diseño del cuaderno de recogida de datos en ensayos clínicos en Openclinica]]></article-title>
<article-title xml:lang="en"><![CDATA[Library for Designing the Case Report Form of Clinical Trials in Openclinica]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sánchez Pedroso]]></surname>
<given-names><![CDATA[Victoria]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rey Kaba]]></surname>
<given-names><![CDATA[Diana Margarita]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramos Mato]]></surname>
<given-names><![CDATA[Grisel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Veliz Alvarez]]></surname>
<given-names><![CDATA[Yeni]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alvarez Fernández]]></surname>
<given-names><![CDATA[Yanet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Barrera Moreira]]></surname>
<given-names><![CDATA[Marta]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional Coordinador de Ensayos Clínicos  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<volume>12</volume>
<numero>2</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1684-18592020000200013&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1684-18592020000200013&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1684-18592020000200013&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción:  El Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) utiliza el software OpenClinica para diseñar los Cuadernos de Recogida de Datos (CRD) de los ensayos clínicos. Cada ensayo tiene características específicas, pero existen datos comunes a todos los ensayos que pueden ser estandarizados.  Objetivo:  Desarrollar una biblioteca de plantillas para el diseño de los CRD.  Método:  Se realizó un análisis documental de los estándares para el manejo de datos en los ensayos clínicos y se analizaron los diseños utilizados en cuatro ensayos desarrollados en OpenClinica.  Resultados:  Según los tipos de datos que se registran en los ensayos clínicos se diseñaron 14 plantillas. Cada plantilla, es un fichero Excel con cinco hojas de trabajo donde se registran todas las definiciones del CRD. Las plantillas se han utilizado en tres ensayos clínicos con resultados favorables.  Conclusión:  Las 14 plantillas que componen la biblioteca CRD fueron diseñadas permitiendo su futura reutilización en la gestión de datos de nuevos ensayos clínicos.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process.  Objective:  To develop a library of templates in order to design the CRF.  Methods:  A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed.  Results:  A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT.  Conclusions:  The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[cuaderno de recogida de datos]]></kwd>
<kwd lng="es"><![CDATA[manejo de datos]]></kwd>
<kwd lng="es"><![CDATA[ensayo clínico]]></kwd>
<kwd lng="es"><![CDATA[OpenClinica]]></kwd>
<kwd lng="en"><![CDATA[case report forms]]></kwd>
<kwd lng="en"><![CDATA[data management]]></kwd>
<kwd lng="en"><![CDATA[clinical trial]]></kwd>
<kwd lng="en"><![CDATA[OpenClinica]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="">
<collab>International Conference Harmonisation</collab>
<source><![CDATA[Normas De Buena Práctica Clínica. Guía Armonizada de ICH Anexo Integrado a ICH E6 (R1): Guía Para La Buena Práctica Clínica ICH E6 (R2) Pauta De Consenso De ICH]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="">
<source><![CDATA[CRD electrónico]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gaddale]]></surname>
<given-names><![CDATA[JR]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management]]></article-title>
<source><![CDATA[Perspect Clin Res]]></source>
<year></year>
<volume>6</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>179-83</page-range></nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="">
<collab>Clinical Data Interchange Standards Consortium Web site</collab>
<source><![CDATA[To Amplify Data's Impact, CDISC Collaborative Standards Forum (CSF)]]></source>
<year>2002</year>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ruberg]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
</person-group>
<source><![CDATA[No one is as smart as everyone: CDISC and the Collaborative Standards Forum]]></source>
<year></year>
<publisher-name><![CDATA[DIA eBusiness Conference]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="">
<collab>OpenClinica Enterprise Web site</collab>
<source><![CDATA[OpenClinica press release. Hundreds of standardized CRFs now available in the OpenClinica Enterprise Case Report Form Library]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="">
<collab>Medical University of South Carolina Web Site</collab>
<source><![CDATA[Data Coordination Unit Case Report Form Library]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="">
<collab>Openclinica</collab>
<source><![CDATA[]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="">
<collab>Openclinica Reference Guide</collab>
<source><![CDATA[Create and Modify Case Report Forms (CRFs)]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="">
<source><![CDATA[Clinical Data Acquisition Standards Harmonization CDASH 2.0]]></source>
<year></year>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
