Division of Biomedical Informatics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA Research Systems, Information Technology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Department of Computer Science, University of Arkansas at Little Rock, Little Rock, Arkansas, USA.
J Am Med Inform Assoc. 2014 Oct;21(e2):e369-73. doi: 10.1136/amiajnl-2013-002616. Epub 2014 Apr 28.
Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning.
管理人体研究是复杂的，不仅涉及机构审查委员会，还涉及研究机构内的许多其他监管和合规实体。其效率直接且实质性地影响临床研究的开展和管理。在本文中，我们报告了阿肯色大学医学科学分校开发的临床研究管理（CLARA）平台。CLARA 是一个全面的基于网络的系统，可以简化研究管理任务，如提交、审查和批准，供调查员和不同的审查委员会在单一的集成平台上使用。CLARA 不仅帮助调查员满足监管要求，还提供了用于管理其他临床研究活动的工具，包括预算、合同和参与者日程安排计划。
