临床试验机构研究者培训的标准操作规程

Procedures for investigators training in institutions for clinical trials

合格的研究者是保证临床试验质量的关键。临床试验机构对研究者的培训 ,是研究者获得参加其所承担试验项目资格的必备条件。本操作规程是依据GCP以及我院对研究者培训的实践制订的。内容包括制定培训计划 ,研究者的岗位培训 ,临床试验项目开始前的研究者培训 ,培训原则 ,培训技巧 ,培训评估 ,培训者资格审定 ,以及文件和档案的建立等。

Qualified investigators play a key role in guaranteeing the quality of clinical trials. Receiving training programs arranged by clinical trial institution for each project is a prerequisite to qualify investigators. The SOP for training on the basis of GCP as well as practical experiences in this paper include establishing training plan, training programs for each position, pre-trail training programs, principles and techniques in training, evaluating training programs, reviewing qualifications of trainers, and maintaining training documentation and archives.