药物临床试验纸质记录表格制定和管理

Formulation and management of paper record forms in clinical trials

数据记录是临床试验最重要工作内容之一。电子记录、纸质记录或二者兼有的记录是临床试验中主要的数据记录形式。近年来,电子记录被推广和使用,但纸质表格和纸质记录仍是临床试验数据记录的重要形式,与电子记录形成有效互补。本文结合日常临床试验实践中的经验,浅谈纸质记录表格制定和管理的注意事项。

Data recording is one of the most important part in clinical trials.The electronic record,paper record,and the mixed record mode are the three major forms of data recording in practices.Recently,electronic record is broadly employed,but the paper forms and paper record still play an important role in clinical trials,and complemented the electronic record.This report aims to provide some advices on forms set up and management of paper record by combining the experiences in our usual works.