Enhancing the Safety of Research Participants

参与临床研究的机构努力保护人类研究参与者的安全。在临床研究中招募人类参与者时，确保使用最新版本的协议和同意书是一种主要的安全干预措施。这通常很难实现，因为通常存在多种版本的协议和同意书。拟议的安全干预措施的目的包括三个主要目标：(1)设计和实施一个基于浏览器的内部网络应用程序，其中包含每种方案的基本信息，包括方案的最新版本和同意书以及预先打印的医嘱；(2)教育研究人员在实施研究过程中每次需要这些项目时，都要一致地使用内部应用程序来获取方案、同意书和预先打印的医嘱；以及(3)设计干预措施，使其可以很容易地复制到其他进行临床研究的机构。

Institutions participating in clinical research strive to protect the safety of human research participants. Making certain that the most current version of the protocol and consent form is used when enrolling human participants in clinical research studies is a major safety intervention. This is often difficult to achieve because multiple versions of the protocol and the consent form often exist. The aims of the proposed safety intervention include three major aims: (1) to design and implement an internal browser-based web application that houses essential information for each protocol including the most current version of the protocol and the consent form and the preprinted medical orders; (2) to educate the research staff to consistently use the intemal application to obtain the protocol, consent form and the preprinted medical orders each time these items are needed when implementing the research process and (3) to design the intervention so that it can be easily duplicated in other institutions conducting clinical research studies.