为一项针对青少年和青年成年人的随机临床试验开发并使用基于网络的数据管理系统。
Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults.
作者信息
Musick Beverly S, Robb Sheri L, Burns Debra S, Stegenga Kristin, Yan Ming, McCorkle Kathy J, Haase Joan E
机构信息
Division of Biostatistics, Indiana University School of Medicine, Indianapolis, USA.
出版信息
Comput Inform Nurs. 2011 Jun;29(6):337-43. doi: 10.1097/NCN.0b013e3181fcbc95.
Recent advances in technology provide support for multisite, Web-based data-entry systems and the storage of data in a centralized location, resulting in immediate access to data for investigators, reduced participant burden and human entry error, and improved integrity of clinical trial data. The purpose of this article was to describe the development of a comprehensive, Web-based data management system for a multisite randomized behavioral intervention trial. Strategies used to create this study-specific data management system included interdisciplinary collaboration, design mapping, feasibility assessments, and input from an advisory board of former patients with characteristics similar to the targeted population. The resulting data management system and development strategies provide a template for other behavioral intervention studies.
技术上的最新进展为多地点、基于网络的数据录入系统以及数据在集中位置的存储提供了支持，从而使研究人员能够立即访问数据，减轻参与者负担并减少人工录入错误，同时提高临床试验数据的完整性。本文的目的是描述一个用于多地点随机行为干预试验的综合性、基于网络的数据管理系统的开发过程。用于创建这个针对本研究的数据管理系统的策略包括跨学科协作、设计映射、可行性评估以及来自具有与目标人群相似特征的前患者咨询委员会的意见。由此产生的数据管理系统和开发策略为其他行为干预研究提供了一个模板。
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