coordination of international multicenter studies: governance and administrative structure coordinación de estudios multicéntricos internacionales: estructura administrativa y reglamentación

Clicks: 199
ID: 153871
2003
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Abstract
A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE), illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.
La ejecución de estudios multicéntricos requiere el establecimiento de procedimientos uniformes, control de calidad, asegurar estandarización, y la colaboración entre las instituciones participantes. Este trabajo describe la estructura y la dinámica de los estudios multicéntricos internacionales, enfocando los aspectos de administración y reglamentación. Se describe la estructura organizativa de un estudio multicéntrico, así como los roles de los integrantes de un sistema de supervisión y coordinación. Se presentan los elementos de un documento de reglamentación y se describen algunas guías y políticas para una colaboración eficaz. La experiencia del estudio internacional colaborativo World Studies of Abuse in the Family Environment (WorldSAFE) se utiliza como ejemplo de la aplicación de estas normas. Un centro de coordinación estadística, así como un documento de auto-reglamentación son elementos esenciales para establecer y mantener la colaboración de las diferentes instituciones que participan en un estudio multicéntrico.
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bangdiwala2003saludcoordination Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Shrikant I. Bangdiwala;Cristiane S. de Paula;Laurie S. Ramiro;Sergio R. Muñoz
Journal journal of anatomy
Year 2003
DOI
DOI not found
URL
http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342003000100008
Keywords
organization and administration multicenter studies organización y administración

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