University of Texas Southwestern Medical Center Dallas, Dallas, TX 75930, USA.
J Investig Med. 2010 Apr;58(4):608-11. doi: 10.231/JIM.0b013e3181c9f68c.
This article describes practical aspects of screening and evaluation of potential study subjects for patient-oriented research. Screening and evaluation comprise the crucial initial steps in the process of any patient-oriented research study. Appropriate infrastructure, operations, and documentation of the procedures needed to efficiently and effectively conduct screening and evaluation are described. A stepwise approach for screening and evaluating potential study subjects for determination of study eligibility is described. The design and conduct of screening and evaluation procedures should be protocol driven and compliant with regulatory requirements.
本文描述了针对以患者为中心的研究筛选和评估潜在研究对象的实用方面。筛选和评估是任何以患者为中心的研究的关键初始步骤。本文介绍了有效且高效进行筛选和评估所需的适当基础设施、操作和程序文件记录。描述了一种用于筛选和评估潜在研究对象以确定研究资格的逐步方法。筛选和评估程序的设计和进行应遵循方案，并符合监管要求。
