Bangdiwala Shrikant I, de Paula Cristiane S, Ramiro Laurie S, Muñoz Sergio R
University of North Carolina, Chapel Hill, NC, USA.
Salud Publica Mex. 2003 Jan-Feb;45(1):58-66. doi: 10.1590/s0036-36342003000100008.
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.
一项精心开展的多中心研究需要确保标准化、程序的一致性、高数据质量以及各研究地点之间的协作。本文描述了多中心研究的组织与动态，重点关注不同文化国家之间的管理和行政结构。文中描述了多中心研究的组织结构，并介绍了一个监督与协调系统，以及多中心研究参与者的角色和职责。还审查了管理文件的要素以及有效协作的指导方针和政策。正在进行的多国合作项目“家庭环境中虐待行为的全球研究”（WorldSAFE）的经验说明了这些指导方针的实施情况。多中心研究必须有一个客观的协调中心，并且研究人员应共同制定一份书面管理文件，以促进协作并保持参与研究的调查人员之间的合作关系。
